H.R. 3580 (110th): Food and Drug Administration Amendments Act of 2007

The text of the bill below is as of Sep 27, 2007 (Passed Congress/Enrolled Bill).

Source: GPO

I

One Hundred Tenth Congress of the United States of America

At the First Session

H. R. 3580

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

1.

Short title

This Act may be cited as the Food and Drug Administration Amendments Act of 2007.

2.

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Title I—Prescription Drug User Fee Amendments of 2007

Sec. 101. Short title; references in title; finding.

Sec. 102. Definitions.

Sec. 103. Authority to assess and use drug fees.

Sec. 104. Fees relating to advisory review of prescription-drug television advertising.

Sec. 105. Reauthorization; reporting requirements.

Sec. 106. Sunset dates.

Sec. 107. Effective date.

Sec. 108. Savings clause.

Sec. 109. Technical amendment; conforming amendment.

Title II—Medical Device User Fee Amendments of 2007

Sec. 201. Short title; references in title; finding.

Subtitle A—Fees related to medical devices

Sec. 211. Definitions.

Sec. 212. Authority to assess and use device fees.

Sec. 213. Reauthorization; reporting requirements.

Sec. 214. Savings clause.

Sec. 215. Additional authorization of appropriations for postmarket safety information.

Sec. 216. Effective date.

Sec. 217. Sunset clause.

Subtitle B—Amendments regarding regulation of medical devices

Sec. 221. Extension of authority for third party review of premarket notification.

Sec. 222. Registration.

Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants; statements; accompanying disclosures.

Sec. 224. Electronic registration and listing.

Sec. 225. Report by Government Accountability Office.

Sec. 226. Unique device identification system.

Sec. 227. Frequency of reporting for certain devices.

Sec. 228. Inspections by accredited persons.

Sec. 229. Study of nosocomial infections relating to medical devices.

Sec. 230. Report by the Food and Drug Administration regarding labeling information on the relationship between the use of indoor tanning devices and development of skin cancer or other skin damage.

Title III—Pediatric Medical Device Safety and Improvement Act of 2007

Sec. 301. Short title.

Sec. 302. Tracking pediatric device approvals.

Sec. 303. Modification to humanitarian device exemption.

Sec. 304. Encouraging pediatric medical device research.

Sec. 305. Demonstration grants for improving pediatric device availability.

Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory committee.

Sec. 307. Postmarket surveillance.

Title IV—Pediatric Research Equity Act of 2007

Sec. 401. Short title.

Sec. 402. Reauthorization of Pediatric Research Equity Act.

Sec. 403. Establishment of internal committee.

Sec. 404. Government Accountability Office report.

Title V—Best Pharmaceuticals for Children Act of 2007

Sec. 501. Short title.

Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.

Sec. 503. Training of pediatric pharmacologists.

Title VI—Reagan-Udall Foundation

Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration.

Sec. 602. Office of the Chief Scientist.

Sec. 603. Critical path public-private partnerships.

Title VII—Conflicts of interest

Sec. 701. Conflicts of interest.

Title VIII—Clinical trial databases

Sec. 801. Expanded clinical trial registry data bank.

Title IX—Enhanced Authorities Regarding Postmarket Safety of Drugs

Subtitle A—Postmarket studies and surveillance

Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk evaluation and mitigation strategies.

Sec. 902. Enforcement.

Sec. 903. No effect on withdrawal or suspension of approval.

Sec. 904. Benefit-risk assessments.

Sec. 905. Active postmarket risk identification and analysis.

Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs.

Sec. 907. No effect on veterinary medicine.

Sec. 908. Authorization of appropriations.

Sec. 909. Effective date and applicability.

Subtitle B—Other provisions to ensure drug safety and surveillance

Sec. 911. Clinical trial guidance for antibiotic drugs.

Sec. 912. Prohibition against food to which drugs or biological products have been added.

Sec. 913. Assuring pharmaceutical safety.

Sec. 914. Citizen petitions and petitions for stay of agency action.

Sec. 915. Postmarket drug safety information for patients and providers.

Sec. 916. Action package for approval.

Sec. 917. Risk communication.

Sec. 918. Referral to advisory committee.

Sec. 919. Response to the institute of medicine.

Sec. 920. Database for authorized generic drugs.

Sec. 921. Adverse drug reaction reports and postmarket safety.

Title X—Food safety

Sec. 1001. Findings.

Sec. 1002. Ensuring the safety of pet food.

Sec. 1003. Ensuring efficient and effective communications during a recall.

Sec. 1004. State and Federal Cooperation.

Sec. 1005. Reportable Food Registry.

Sec. 1006. Enhanced aquaculture and seafood inspection.

Sec. 1007. Consultation regarding genetically engineered seafood products.

Sec. 1008. Sense of Congress.

Sec. 1009. Annual report to Congress.

Sec. 1010. Publication of annual reports.

Sec. 1011. Rule of construction.

Title XI—Other provisions

Subtitle A—In general

Sec. 1101. Policy on the review and clearance of scientific articles published by FDA employees.

Sec. 1102. Priority review to encourage treatments for tropical diseases.

Sec. 1103. Improving genetic test safety and quality.

Sec. 1104. NIH Technical amendments.

Sec. 1105. Severability clause.

Subtitle B—Antibiotic access and innovation

Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials.

Sec. 1112. Orphan antibiotic drugs.

Sec. 1113. Exclusivity of certain drugs containing single enantiomers.

Sec. 1114. Report.

I

Prescription Drug User Fee Amendments of 2007

101.

Short title; references in title; finding

(a)

Short title

This title may be cited as the Prescription Drug User Fee Amendments of 2007.

(b)

References in title

Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(c)

Finding

The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

102.

Definitions

Section 735 (21 U.S.C. 379g) is amended—

(1)

in the matter before paragraph (1), by striking For purposes of this subchapter and inserting For purposes of this part;

(2)

in paragraph (1)—

(A)

in subparagraph (A), by striking 505(b)(1), and inserting 505(b), or;

(B)

by striking subparagraph (B);

(C)

by redesignating subparagraph (C) as subparagraph (B); and

(D)

in the matter following subparagraph (B), as so redesignated, by striking subparagraph (C) and inserting subparagraph (B);

(3)

in paragraph (3)(C)—

(A)

by striking 505(j)(7)(A) and inserting 505(j)(7)(A) (not including the discontinued section of such list); and

(B)

by inserting before the period (not including the discontinued section of such list);

(4)

in paragraph (4), by inserting before the period at the end the following: (such as capsules, tablets, or lyophilized products before reconstitution);

(5)

by amending paragraph (6)(F) to read as follows:

(F)

Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:

(i)

Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii)

Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii)

Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv)

Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies).

(v)

Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities).

;

(6)

in paragraph (8)—

(A)

by striking April of the preceding fiscal year and inserting October of the preceding fiscal year; and

(B)

by striking April 1997 and inserting October 1996;

(7)

by redesignating paragraph (9) as paragraph (11); and

(8)

by inserting after paragraph (8) the following paragraphs:

(9)

The term person includes an affiliate thereof.

(10)

The term active, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.

.

103.

Authority to assess and use drug fees

(a)

Types of fees

Section 736(a) (21 U.S.C. 379h(a)) is amended—

(1)

in the matter preceding paragraph (1), by striking 2003 and inserting 2008;

(2)

in paragraph (1)—

(A)

in subparagraph (D)—

(i)

in the heading, by inserting or withdrawn before filing after refused for filing; and

(ii)

by inserting before the period at the end the following: or withdrawn without a waiver before filing;

(B)

by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and

(C)

by inserting after subparagraph (D) the following:

(E)

Fees for applications previously refused for filing or withdrawn before filing

A human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).

; and

(3)

in paragraph (2)—

(A)

in subparagraph (A), by striking subparagraph (B) and inserting subparagraphs (B) and (C); and

(B)

by adding at the end the following:

(C)

Special rules for positron emission tomography drugs

(i)

In general

Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application.

(ii)

Exception from annual establishment fee

Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that—

(I)

the person is a not-for-profit medical center that has only 1 establishment for the production of positron emission tomography drugs; and

(II)

at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.

(iii)

Definition

For purposes of this subparagraph, the term positron emission tomography drug has the meaning given to the term compounded positron emission tomography drug in section 201(ii), except that paragraph (1)(B) of such section shall not apply.

.

(b)

Fee revenue amounts

Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows:

(b)

Fee revenue amounts

(1)

In general

For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

(A)

$392,783,000; and

(B)

an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).

(2)

Types of fees

Of the total revenue amount determined for a fiscal year under paragraph (1)—

(A)

one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements);

(B)

one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and

(C)

one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products).

(3)

Modified workload adjustment factor for fiscal year 2007

For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12-month period for which data on such submissions is available.

(4)

Additional fee revenues for drug safety

(A)

In general

For each of the fiscal years 2008 through 2012, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) for $392,783,000.

(B)

Amount determined

For each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of—

(i)

$392,783,000; plus

(ii)
(I)

for fiscal year 2008, $25,000,000;

(II)

for fiscal year 2009, $35,000,000;

(III)

for fiscal year 2010, $45,000,000;

(IV)

for fiscal year 2011, $55,000,000; and

(V)

for fiscal year 2012, $65,000,000.

.

(c)

Adjustments to fees

(1)

Inflation adjustment

Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended—

(A)

in the matter preceding subparagraph (A), by striking The revenues established in subsection (b) and inserting For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b);

(B)

in subparagraph (A), by striking or at the end;

(C)

in subparagraph (B), by striking the period at the end and inserting , or;

(D)

by inserting after subparagraph (B) the following:

(C)

the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.

; and

(E)

in the matter following subparagraph (C) (as added by subparagraph (D)), by striking fiscal year 2003 and inserting fiscal year 2008.

(2)

Workload adjustment

Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended—

(A)

in the matter preceding subparagraph (A), by striking Beginning with fiscal year 2004, and inserting For fiscal year 2009 and subsequent fiscal years,;

(B)

in subparagraph (A), in the first sentence—

(i)

by striking human drug applications, and inserting human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),;

(ii)

by striking commercial investigational new drug applications,; and

(iii)

by inserting before the period the following: , and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available;

(C)

in subparagraph (B), by adding at the end the following: Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.; and

(D)

by adding at the end the following:

(C)

The Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make recommendations, if warranted, for future changes in the methodology for calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been completed.

.

(3)

Rent and rent-related cost adjustment

Section 736(c) (21 U.S.C. 379h(c)) is amended—

(A)

by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and

(B)

by inserting after paragraph (2) the following:

(3)

Rent and rent-related cost adjustment

For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount established in subsection (b) if actual costs paid for rent and rent-related expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2006 for such fiscal year, and shall not exceed $11,721,000 for any fiscal year.

.

(4)

Final year adjustment

Paragraph (4) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is amended to read as follows:

(4)

Final year adjustment

(A)

Increase in fees

For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2013. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2012. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made.

(B)

Decrease in fees

(i)

In general

For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), decrease the fee revenues and fees established in subsection (b) by the amount determined in clause (ii), if, for fiscal year 2009 or 2010—

(I)

the amount of the total appropriations for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriations for the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under paragraph (1); and

(II)

the amount of the total appropriations expended for the process for the review of human drug applications at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations expended for the process for the review of human drug applications at the Food and Drug Administration for fiscal year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under paragraph (1).

(ii)

Amount of decrease

The amount determined in this clause is the lesser of—

(I)

the amount equal to the sum of the amounts that, for each of fiscal years 2009 and 2010, is the lesser of—

(aa)

the excess amount described in clause (i)(II) for such fiscal year; or

(bb)

the amount specified in subsection (b)(4)(B)(ii) for such fiscal year; or

(II)

$65,000,000.

(iii)

Limitations

(I)

Fiscal year condition

In making the determination under clause (ii), an amount described in subclause (I) of such clause for fiscal year 2009 or 2010 shall be taken into account only if subclauses (I) and (II) of clause (i) apply to such fiscal year.

(II)

Relation to subparagraph (A)

The Secretary shall limit any decrease under this paragraph if such a limitation is necessary to provide for the 3 months of operating reserves described in subparagraph (A).

.

(5)

Limit

Paragraph (5) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is amended by striking 2002 and inserting 2007.

(d)

Fee waiver or reduction

Section 736(d) (21 U.S.C. 379h(d)) is amended—

(1)

in paragraph (1), in the matter preceding subparagraph (A)—

(A)

by inserting after The Secretary shall grant the following: to a person who is named as the applicant in a human drug application; and

(B)

by inserting to that person after one or more fees assessed;

(2)

by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

(3)

by inserting after paragraph (1) the following:

(2)

Considerations

In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

; and

(4)

in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the period the following: , and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.

(e)

Crediting and availability of fees

(1)

Authorization of appropriations

Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows:

(3)

Authorization of appropriations

For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4) of this subsection.

.

(2)

Offset

Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows:

(4)

Offset

If the sum of the cumulative amount of fees collected under this section for the fiscal years 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.

.

(f)

Exemption for orphan drugs

Section 736 (21 U.S.C. 379h) is further amended by adding at the end the following:

(k)

Orphan drugs

(1)

Exemption

A drug designated under section 526 for a rare disease or condition and approved under section 505 or under section 351 of the Public Health Service Act shall be exempt from product and establishment fees under this section, if the drug meets all of the following conditions:

(A)

The drug meets the public health requirements contained in this Act as such requirements are applied to requests for waivers for product and establishment fees.

(B)

The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue during the previous year.

(2)

Evidence of qualification

An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.

.

(g)

Conforming amendment

Section 736(a) (21 U.S.C. 379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by striking (c)(4) each place such term appears and inserting (c)(5).

(h)

Technical amendment

(1)

Amendment

Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is amended by striking the first sentence and inserting the following: Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended..

(2)

Effective date

Paragraph (1) shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687).

104.

Fees relating to advisory review of prescription-drug television advertising

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following:

736A.

Fees relating to advisory review of prescription-drug television advertising

(a)

Types of direct-to-consumer television advertisement review fees

Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:

(1)

Advisory review fee

(A)

In general

With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a DTC advertisement), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).

(B)

Exception for required submissions

A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review.

(C)

Notice to Secretary of number of advertisements

Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007.

(D)

Payment

(i)

In general

The fee required by subparagraph (A) (referred to in this section as an advisory review fee) shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after the date of the enactment of the Food and Drug Administration Amendments of 2007 or an earlier date as specified by the Secretary.

(ii)

Effect of submission

Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).

(iii)

Notice regarding carryover submissions

In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.

(E)

Modification of advisory review fee

(i)

Late payment

If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 or an earlier date specified by the Secretary), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(ii)

Exceeding identified number of submissions

If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(F)

Limits

(i)

Submissions

For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.

(ii)

No refunds

Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded.

(iii)

No waivers, exemptions, or reductions

The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.

(iv)

Right to advisory review not transferable

The right to an advisory review under this paragraph is not transferable, except to a successor in interest.

(2)

Operating reserve fee

(A)

In general

Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee established under subsection (d)(2) (referred to in this section as an operating reserve fee) for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.

(B)

Payment

Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—

(i)

October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or

(ii)

for fiscal year 2008, 120 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 or an earlier date specified by the Secretary.

(C)

Late notice of submission

If, in the first fiscal year of a person’s participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(D)

Late payment

(i)

In general

Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—

(I)

for fiscal year 2008, 150 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 or an earlier date specified by the Secretary; or

(II)

in any subsequent year, November 1.

(ii)

Complete payment

The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(iii)

Amount

Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d).

(b)

Advisory review fee revenue amounts

Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).

(c)

Adjustments

(1)

Inflation adjustment

Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—

(A)

the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(B)

the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

(C)

the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.
(2)

Workload adjustment

Beginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:

(A)

The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

(B)

Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.

(3)

Annual fee setting for advisory review

(A)

In general

Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under subsection (a)(1)(F)(i).

(B)

Fiscal year 2008 fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.

(C)

Annual fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.

(D)

Limit

The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.

(d)

Operating reserves

(1)

In general

The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.

(2)

Fee setting

The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.

(3)

Use of operating reserve

The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.

(4)

Refund of operating reserves

Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).

(e)

Effect of failure To pay fees

Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.

(f)

Effect of inadequate funding of program

(1)

Initial funding

If on November 1, 2007, or 120 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.

(2)

Later fiscal years

Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.

(g)

Crediting and availability of fees

(1)

In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.

(2)

Collections and appropriation acts

(A)

In general

The fees authorized by this section—

(i)

shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii)

shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.

(B)

Review employees

For purposes of subparagraph (A)(ii), the term full-time equivalent review employees means the total combined number of full-time equivalent employees in—

(i)

the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and

(ii)

the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

(3)

Authorization of appropriations

For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).

(4)

Offset

Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.

(h)

Definitions

For purposes of this section:

(1)

The term advisory review means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this Act prior to its initial public dissemination.

(2)

The term advisory review fee has the meaning indicated for such term in subsection (a)(1)(D).

(3)

The term carry over submission means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.

(4)

The term direct-to-consumer television advertisement means an advertisement for a prescription drug product (as defined in section 735(3)) intended to be displayed on any television channel for less than 3 minutes.

(5)

The term DTC advertisement has the meaning indicated for such term in subsection (a)(1)(A).

(6)

The term operating reserve fee has the meaning indicated for such term in subsection (a)(2)(A).

(7)

The term person includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.

(8)

The term process for the advisory review of prescription drug advertising means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.

(9)

The term resources allocated for the process for the advisory review of prescription drug advertising means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for—

(A)

officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;

(B)

management of information, and the acquisition, maintenance, and repair of computer resources;

(C)

leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;

(D)

collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and

(E)

terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary.

(10)

The term resubmission means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary’s comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.

(11)

The term submission for advisory review means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.

.

105.

Reauthorization; reporting requirements

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as amended by section 104, is further amended by inserting after section 736A the following:

736B.

Reauthorization; reporting requirements

(a)

Performance report

Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.

(b)

Fiscal report

Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c)

Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d)

Reauthorization

(1)

Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with—

(A)

the Committee on Energy and Commerce of the House of Representatives;

(B)

the Committee on Health, Education, Labor, and Pensions of the Senate;

(C)

scientific and academic experts;

(D)

health care professionals;

(E)

representatives of patient and consumer advocacy groups; and

(F)

the regulated industry.

(2)

Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall—

(A)

publish a notice in the Federal Register requesting public input on the reauthorization;

(B)

hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C)

provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

(D)

publish the comments on the Food and Drug Administration’s Internet Web site.

(3)

Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2).

(4)

Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A)

present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B)

publish such recommendations in the Federal Register;

(C)

provide for a period of 30 days for the public to provide written comments on such recommendations;

(D)

hold a meeting at which the public may present its views on such recommendations; and

(E)

after consideration of such public views and comments, revise such recommendations as necessary.

(5)

Transmittal of recommendations

Not later than January 15, 2012, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6)

Minutes of negotiation meetings

(A)

Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B)

Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

.

106.

Sunset dates

(a)

Authorization

The amendments made by sections 102, 103, and 104 cease to be effective October 1, 2012.

(b)

Reporting requirements

The amendment made by section 105 ceases to be effective January 31, 2013.

107.

Effective date

The amendments made by this title shall take effect on October 1, 2007, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1, 2007, regardless of the date of the enactment of this Act.

108.

Savings clause

Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.

109.

Technical amendment; conforming amendment

(a)

Section 739 (21 U.S.C. 379j–11) is amended in the matter preceding paragraph (1) by striking subchapter and inserting part.

(b)

Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended by striking 735(9) and inserting 735(11).

II

Medical Device User Fee Amendments of 2007

201.

Short title; references in title; finding

(a)

Short title

This title may be cited as the Medical Device User Fee Amendments of 2007.

(b)

References in title

Except as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(c)

Finding

The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

A

Fees related to medical devices

211.

Definitions

Section 737 is amended—

(1)

in the matter preceding paragraph (1), by striking For purposes of this subchapter and inserting For purposes of this part;

(2)

by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;

(3)

by inserting after paragraph (4) the following:

(5)

The term 30-day notice means a notice under section 515(d)(6) that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.

(6)

The term request for classification information means a request made under section 513(g) for information respecting the class in which a device has been classified or the requirements applicable to a device.

(7)

The term annual fee, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.

;

(4)

in paragraph (10), as so redesignated—

(A)

by striking April of the preceding fiscal year and inserting October of the preceding fiscal year; and

(B)

by striking April 2002 and inserting October 2001;

(5)

by inserting after paragraph (10), as so amended, the following:

(11)

The term person includes an affiliate thereof.

; and

(6)

by inserting after paragraph (12), as so redesignated, the following:

(13)

The term establishment subject to a registration fee means an establishment that is required to register with the Secretary under section 510 and is one of the following types of establishments:

(A)

Manufacturer

An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person.

(B)

Single-use device reprocessor

An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient.

(C)

Specification developer

An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

.

212.

Authority to assess and use device fees

(a)

Types of fees

(1)

In general

Section 738(a) (21 U.S.C. 379j(a)) is amended—

(A)

in paragraph (1), by striking Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002 and inserting Beginning in fiscal year 2008; and

(B)

by amending the designation and heading of paragraph (2) to read as follows:

(2)

Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device

.

(2)

Fee amounts

Section 738(a)(2)(A) (21 U.S.C. 379j(a)(2)(A)) is amended—

(A)

in clause (iii), by striking a fee equal to the fee that applies and inserting a fee equal to 75 percent of the fee that applies;

(B)

in clause (iv), by striking 21.5 percent and inserting 15 percent;

(C)

in clause (v), by striking 7.2 percent and inserting 7 percent;

(D)

by redesignating clauses (vi) and (vii) as clauses (vii) and (viii), respectively;

(E)

by inserting after clause (v) the following:

(vi)

For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).

;

(F)

in clause (viii), as so redesignated—

(i)

by striking 1.42 percent and inserting 1.84 percent; and

(ii)

by striking , subject to any adjustment under subsection (e)(2)(C)(ii); and

(G)

by inserting after such clause (viii) the following:

(ix)

For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

(x)

For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).

.

(3)

Payment

Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) is amended to read as follows:

(C)

Payment

The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to section 515(c)(4) shall pay such fees upon submission of the first portion of such applications.

.

(4)

Refunds

Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) is amended—

(A)

in clause (iii), by striking the last two sentences; and

(B)

by adding after clause (iii) the following:

(iv)

Modular applications withdrawn before first action

The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 515(c)(4) that is withdrawn before a second portion is submitted and before a first action on the first portion.

(v)

Later withdrawn modular applications

If an application submitted under section 515(c)(4) is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted.

(vi)

Sole discretion to refund

The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.

.

(5)

Annual establishment registration fee

Section 738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) the following:

(3)

Annual establishment registration fee

(A)

In general

Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 510 beginning with its registration for fiscal year 2008.

(B)

Exception

No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act), unless a device manufactured by the establishment is to be distributed commercially.

(C)

Payment

The fee required under subparagraph (A) shall be due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.

.

(b)

Fee amounts

Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows:

(b)

Fee amounts

Except as provided in subsections (c), (d), (e), and (h) the fees under subsection (a) shall be based on the following fee amounts:

Fee TypeFiscal
Year
2008
Fiscal
Year
2009
Fiscal
Year
2010
Fiscal
Year
2011
Fiscal
Year
2012
Premarket Application$185,000$200,725$217,787$236,298$256,384
Establishment Registration$1,706$1,851$2,008$2,179$2,364.

.

(c)

Annual fee setting

(1)

In general

Section 738(c) (21 U.S.C. 379j(c)(1)) is amended—

(A)

in the subsection heading, by striking Annual Fee Setting and inserting Annual fee setting; and

(B)

in paragraph (1), by striking the last sentence.

(2)

Adjustment of annual establishment fee

Section 738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is further amended—

(A)

by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

(B)

by inserting after paragraph (1) the following:

(2)

Adjustment

(A)

In general

When setting fees for fiscal year 2010, the Secretary may increase the fee under subsection (a)(3)(A) (applicable to establishments subject to registration) only if the Secretary estimates that the number of establishments submitting fees for fiscal year 2009 is fewer than 12,250. The percentage increase shall be the percentage by which the estimate of establishments submitting fees in fiscal year 2009 is fewer than 12,750, but in no case may the percentage increase be more than 8.5 percent over that specified in subsection (b) for fiscal year 2010. If the Secretary makes any adjustment to the fee under subsection (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that such fee for fiscal year 2011 is equal to the adjusted fee for fiscal year 2010 increased by 8.5 percent, and such fee for fiscal year 2012 is equal to the adjusted fee for fiscal year 2011 increased by 8.5 percent.

(B)

Publication

For any adjustment made under subparagraph (A), the Secretary shall publish in the Federal Register the Secretary’s determination to make the adjustment and the rationale for the determination.

; and

(C)

in paragraph (4), as redesignated by this paragraph, in subparagraph (A)—

(i)

by striking For fiscal years 2006 and 2007, the Secretary and inserting The Secretary; and

(ii)

by striking for the first month of fiscal year 2008 and inserting for the first month of the next fiscal year.

(d)

Small businesses; fee waiver and fee reduction regarding premarket approval

(1)

In general

Section 738(d)(1) (21 U.S.C. 379j(d)(1)) is amended—

(A)

by striking , partners, and parent firms; and

(B)

by striking clauses (i) through (vi) of subsection (a)(2)(A) and inserting clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A).

(2)

Rules relating to premarket approval fees

(A)

Definition

Section 738(d)(2)(A) (21 U.S.C. 379j(d)(2)(A)) is amended by striking , partners, and parent firms.

(B)

Evidence of qualification

Section 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended—

(i)

by striking (B) Evidence of qualification.—An applicant and inserting the following:

(B)

Evidence of qualification

(i)

In general

An applicant

;

(ii)

by striking The applicant shall support its claim and inserting the following:

(ii)

Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim

;

(iii)

by striking , partners, and parent firms each place it appears;

(iv)

by striking the last sentence and inserting If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.; and

(v)

by adding at the end the following:

(iii)

Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

.

(3)

Reduced fees

Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:

(C)

Reduced fees

Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—

(i)

25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, or periodic reporting concerning a class III device; and

(ii)

50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.

.

(e)

Small businesses; fee reduction regarding premarket notification submissions

(1)

In general

Section 738(e)(1) (21 U.S.C. 379j(e)(1)) is amended—

(A)

by striking 2004 and inserting 2008; and

(B)

by striking (a)(2)(A)(vii) and inserting (a)(2)(A)(viii).

(2)

Rules relating to premarket notification submissions

(A)

Definition

Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking , partners, and parent firms.

(B)

Evidence of qualification

Section 738(e)(2)(B) (21 U.S.C. 379j(e)(2)(B)) is amended—

(i)

by striking (B) Evidence of qualification.—An applicant and inserting the following:

(B)

Evidence of qualification

(i)

In general

An applicant

;

(ii)

by striking The applicant shall support its claim and inserting the following:

(ii)

Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim

;

(iii)

by striking , partners, and parent firms each place it appears;

(iv)

by striking the last sentence and inserting If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.; and

(v)

by adding at the end the following:

(iii)

Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

.

(3)

Reduced fees

Section 738(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows:

(C)

Reduced fees

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 50 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).

.

(f)

Effect of failure To pay fees

Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:

(f)

Effect of failure To pay fees

(1)

No acceptance of submissions

A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid.

(2)

No registration

Registration information submitted under section 510 by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 510.

.

(g)

Conditions

Section 738(g) (21 U.S.C. 379j(g)) is amended—

(1)

by striking paragraph (1) and inserting the following:

(1)

Performance goals; termination of program

With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—

(A)

the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $205,720,000 multiplied by the adjustment factor applicable to such fiscal year; or

(B)

fees were not assessed under subsection (a) for the previous fiscal year.

; and

(2)

by amending paragraph (2) to read as follows:

(2)

Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

.

(h)

Crediting and availability of fees

(1)

Authorization of appropriations

Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amended to read as follows:

(3)

Authorizations of appropriations

There are authorized to be appropriated for fees under this section—

(A)

$48,431,000 for fiscal year 2008;

(B)

$52,547,000 for fiscal year 2009;

(C)

$57,014,000 for fiscal year 2010;

(D)

$61,860,000 for fiscal year 2011; and

(E)

$67,118,000 for fiscal year 2012.

.

(2)

Offset

Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is amended to read as follows:

(4)

Offset

If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2011, exceeds the amount of fees specified in aggregate in paragraph (3) for these four fiscal years, the aggregate amount in excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.

.

213.

Reauthorization; reporting requirements

Part 3 of subchapter C of chapter VII is amended by inserting after section 738 the following:

738A.

Reauthorization; reporting requirements

(a)

Reports

(1)

Performance report

For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.

(2)

Fiscal report

For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(3)

Public availability

The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.

(b)

Reauthorization

(1)

Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with—

(A)

the Committee on Energy and Commerce of the House of Representatives;

(B)

the Committee on Health, Education, Labor, and Pensions of the Senate;

(C)

scientific and academic experts;

(D)

health care professionals;

(E)

representatives of patient and consumer advocacy groups; and

(F)

the regulated industry.

(2)

Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall—

(A)

publish a notice in the Federal Register requesting public input on the reauthorization;

(B)

hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1);

(C)

provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

(D)

publish the comments on the Food and Drug Administration’s Internet Web site.

(3)

Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2).

(4)

Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A)

present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B)

publish such recommendations in the Federal Register;

(C)

provide for a period of 30 days for the public to provide written comments on such recommendations;

(D)

hold a meeting at which the public may present its views on such recommendations; and

(E)

after consideration of such public views and comments, revise such recommendations as necessary.

(5)

Transmittal of recommendations

Not later than January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6)

Minutes of negotiation meetings

(A)

Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B)

Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

.

214.

Savings clause

Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250), and notwithstanding the amendments made by this subtitle, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle, shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.

215.

Additional authorization of appropriations for postmarket safety information

For the purpose of collecting, developing, reviewing, and evaluating postmarket safety information on medical devices, there are authorized to be appropriated to the Food and Drug Administration, in addition to the amounts authorized by other provisions of law for such purpose—

(1)

$7,100,000 for fiscal year 2008;

(2)

$7,455,000 for fiscal year 2009;

(3)

$7,827,750 for fiscal year 2010;

(4)

$8,219,138 for fiscal year 2011; and

(5)

$8,630,094 for fiscal year 2012.

216.

Effective date

The amendments made by this subtitle shall take effect on October 1, 2007, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act.

217.

Sunset clause

The amendments made by this subtitle cease to be effective October 1, 2012, except that section 738A of the Federal Food, Drug, and Cosmetic Act (regarding annual performance and financial reports) ceases to be effective January 31, 2013.

B

Amendments regarding regulation of medical devices

221.

Extension of authority for third party review of premarket notification

Section 523(c) (21 U.S.C. 360m(c)) is amended by striking 2007 and inserting 2012.

222.

Registration

(a)

Annual registration of producers of drugs and devices

Section 510(b) (21 U.S.C. 360(b)) is amended—

(1)

by striking (b) On or before and inserting (b)(1) On or before;

(2)

by striking or a device or devices; and

(3)

by adding at the end the following:

(2)

During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments.

.

(b)

Registration of foreign establishments

Section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking On or before December 31 and all that follows and inserting the following:

Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—

(A)

upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and

(B)

each establishment subject to the requirements of subparagraph (A) shall thereafter—

(i)

with respect to drugs, register with the Secretary on or before December 31 of each year; and

(ii)

with respect to devices, register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.

.

223.

Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants; statements; accompanying disclosures

Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter preceding subparagraph (A), by striking Each person and all that follows through the following information: and inserting Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:.

224.

Electronic registration and listing

Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:

(p)

Registrations and listings under this section (including the submission of updated information) shall be submitted to the Secretary by electronic means unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.

.

225.

Report by Government Accountability Office

(a)

In general

The Comptroller General of the United States shall conduct a study on the appropriate use of the process under section 510(k) of the Federal Food, Drug, and Cosmetic Act as part of the device classification process to determine whether a new device is as safe and effective as a classified device.

(b)

Consideration

In determining the effectiveness of the premarket notification and classification authority under section 510(k) and subsections (f) and (i) of section 513 of the Federal Food, Drug, and Cosmetic Act, the study under subsection (a) shall consider the Secretary of Health and Human Services’s evaluation of the respective intended uses and technologies of such devices, including the effectiveness of such Secretary’s comparative assessment of technological characteristics such as device materials, principles of operations, and power sources.

(c)

Report

Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study.

226.

Unique device identification system

(a)

In general

Section 519 (21 U.S.C. 360i) is amended—

(1)

by redesignating subsection (f) as subsection (g); and

(2)

by inserting after subsection (e) the following:

(f)

Unique device identification system

The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.

.

(b)

Conforming amendment

Section 303 (21 U.S.C. 333) is amended—

(1)

by redesignating the subsection that follows subsection (e) as subsection (f); and

(2)

in paragraph (1)(B)(ii) of subsection (f), as so redesignated, by striking 519(f) and inserting 519(g).

227.

Frequency of reporting for certain devices

Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by striking were to recur; and inserting the following:

were to recur, which report under this subparagraph—

(i)

shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is—

(I)

a class III device;

(II)

a class II device that is permanently implantable, is life supporting, or is life sustaining; or

(III)

a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health;

(ii)

shall, if the device is not subject to clause (i), be submitted in accordance with criteria established by the Secretary for reports made pursuant to this clause, which criteria shall require the reports to be in summary form and made on a quarterly basis; or

(iii)

shall, if the device is imported into the United States and for which part 803 of title 21, Code of Federal Regulations (or successor regulations) requires an importer to submit a report to the manufacturer, be submitted by the importer to the manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations)

.

228.

Inspections by accredited persons

Section 704(g) (21 U.S.C. 374(g)) is amended—

(1)

in paragraph (1), by striking Not later than one year after the date of the enactment of this subsection, the Secretary and inserting The Secretary;

(2)

in paragraph (2), by—

(A)

striking Not later than 180 days after the date of enactment of this subsection, the Secretary and inserting The Secretary; and

(B)

striking the fifth sentence;

(3)

in paragraph (3), by adding at the end the following:

(F)

Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration.

(G)

Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).

;

(4)

by amending paragraph (6) to read as follows:

(6)
(A)

Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met:

(i)

The Secretary classified the results of the most recent inspection of the establishment as no action indicated or voluntary action indicated.

(ii)

With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that—

(I)

provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection;

(II)

states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment;

(III)

identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and

(IV)

includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment—

(aa)

at least 1 of such devices is marketed in the United States; and

(bb)

at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments.

(B)
(i)

Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that—

(I)

denies clearance to participate as provided under subparagraph (C); or

(II)

makes a request under clause (ii).

(ii)

The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice—

(I)

compliance data for the establishment in accordance with clause (iii)(I); or

(II)

information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II).

The owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request.
(iii)
(I)

The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 501(h) and with other applicable provisions of this Act. Such data shall include complete reports of inspectional findings regarding good manufacturing practice or other quality control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

(II)

A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1).

(iv)

A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C).

(C)
(i)

The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence.

(ii)

The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination.

(iii)
(I)

The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person.

(II)

If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii).

(iv)

In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.

;

(5)

in paragraph (7)—

(A)

in subparagraph (A), by striking (A) Persons and all that follows through the end and inserting the following: (A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment’s designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.; and

(B)

by adding at the end the following:

(F)

For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.

; and

(6)

in paragraph (10)(C)(iii), by striking based and inserting base.

229.

Study of nosocomial infections relating to medical devices

(a)

In general

The Comptroller General of the United States shall conduct a study on—

(1)

the number of nosocomial infections attributable to new and reused medical devices; and

(2)

the causes of such nosocomial infections, including the following:

(A)

Reprocessed single-use devices.

(B)

Handling of sterilized medical devices.

(C)

In-hospital sterilization of medical devices.

(D)

Health care professionals' practices for patient examination and treatment.

(E)

Hospital-based policies and procedures for infection control and prevention.

(F)

Hospital-based practices for handling of medical waste.

(G)

Other causes.

(b)

Report

Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study.

(c)

Definition

In this section, the term nosocomial infection means an infection that is acquired while an individual is a patient at a hospital and was neither present nor incubating in the patient prior to receiving services in the hospital.

230.

Report by the Food and Drug Administration regarding labeling information on the relationship between the use of indoor tanning devices and development of skin cancer or other skin damage

(a)

In general

The Secretary of Health and Human Services (referred to in this section as the Secretary), acting through the Commissioner of Food and Drugs, shall determine—

(1)

whether the labeling requirements for indoor tanning devices, including the positioning requirements, provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; and

(2)
(A)

whether modifying the warning label required on tanning beds to read, “Ultraviolet radiation can cause skin cancer”, or any other additional warning, would communicate the risks of indoor tanning more effectively; or

(B)

whether there is no warning that would be capable of adequately communicating such risks.

(b)

Consumer testing

In making the determinations under subsection (a), the Secretary shall conduct appropriate consumer testing to determine consumer understanding of label warnings.

(c)

Report

Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to the Congress a report that provides the determinations under subsection (a). In addition, the Secretary shall include in the report the measures being implemented by the Secretary to significantly reduce the risks associated with indoor tanning devices.

III

Pediatric Medical Device Safety and Improvement Act of 2007

301.

Short title

This title may be cited as the Pediatric Medical Device Safety and Improvement Act of 2007.

302.

Tracking pediatric device approvals

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515 the following:

515A.

Pediatric uses of devices

(a)

New devices

(1)

In general

A person that submits to the Secretary an application under section 520(m), or an application (or supplement to an application) or a product development protocol under section 515, shall include in the application or protocol the information described in paragraph (2).

(2)

Required information

The application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available—

(A)

a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and

(B)

the number of affected pediatric patients.

(3)

Annual report

Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—

(A)

the number of devices approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure;

(B)

the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;

(C)

the number of pediatric devices approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v); and

(D)

the review time for each device described in subparagraphs (A), (B), and (C).

(b)

Determination of pediatric effectiveness based on similar course of disease or condition or similar effect of device on adults

(1)

In general

If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate.

(2)

Extrapolation between subpopulations

A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.

(c)

Pediatric Subpopulation

For purposes of this section, the term pediatric subpopulation has the meaning given the term in section 520(m)(6)(E)(ii).

.

303.

Modification to humanitarian device exemption

(a)

In general

Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended—

(1)

in paragraph (3), by striking No and inserting Except as provided in paragraph (6), no;

(2)

in paragraph (5)—

(A)

by inserting , if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met, after public health; and

(B)

by adding at the end the following: If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.; and

(3)

by striking paragraph (6) and inserting after paragraph (5) the following new paragraphs:

(6)
(A)

Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply:

(i)
(I)

The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.

(II)

The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to the date of the enactment of the Pediatric Medical Device Safety and Improvement Act of 2007.

(ii)

During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A).

(iii)

Such person immediately notifies the Secretary if the number of such devices distributed during any calendar year exceeds the annual distribution number referred to in clause (ii).

(iv)

The request for such exemption is submitted on or before October 1, 2012.

(B)

The Secretary may inspect the records relating to the number of devices distributed during any calendar year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.

(C)

A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A).

(D)

If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device for any sales of such device after such notification.

(E)
(i)

In this subsection, the term pediatric patients means patients who are 21 years of age or younger at the time of the diagnosis or treatment.

(ii)

In this subsection, the term pediatric subpopulation means 1 of the following populations:

(I)

Neonates.

(II)

Infants.

(III)

Children.

(IV)

Adolescents.

(7)

The Secretary shall refer any report of an adverse event regarding a device for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In considering the report, the Director of the Office of Pediatric Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this Act in response to the report.

(8)

The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee of all devices described in paragraph (6) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for which it is granted.

.

(b)

Report

Not later than January 1, 2012, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the impact of allowing persons granted an exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a device to profit from such device pursuant to section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection (a)), including—

(1)

an assessment of whether such section 520(m)(6) (as amended by subsection (a)) has increased the availability of pediatric devices for conditions that occur in small numbers of children, including any increase or decrease in the number of—

(A)

exemptions granted under such section 520(m)(2) for pediatric devices; and

(B)

applications approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to treat, diagnose, or cure conditions that occur in pediatric patients or for devices labeled for use in a pediatric population;

(2)

the conditions or diseases the pediatric devices were intended to treat or diagnose and the estimated size of the pediatric patient population for each condition or disease;

(3)

the costs of purchasing pediatric devices, based on a representative sampling of children’s hospitals;

(4)

the extent to which the costs of such devices are covered by health insurance;

(5)

the impact, if any, of allowing profit on access to such devices for patients;

(6)

the profits made by manufacturers for each device that receives an exemption;

(7)

an estimate of the extent of the use of the pediatric devices by both adults and pediatric populations for a condition or disease other than the condition or disease on the label of such devices;

(8)

recommendations of the Comptroller General of the United States regarding the effectiveness of such section 520(m)(6) (as amended by subsection (a)) and whether any modifications to such section 520(m)(6) (as amended by subsection (a)) should be made;

(9)

existing obstacles to pediatric device development; and

(10)

an evaluation of the demonstration grants described in section 305, which shall include an evaluation of the number of pediatric medical devices—

(A)

that have been or are being studied in children; and

(B)

that have been submitted to the Food and Drug Administration for approval, clearance, or review under such section 520(m) (as amended by this Act) and any regulatory actions taken.

(c)

Guidance

Not later than 180 days after the date of the enactment of this Act, the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

304.

Encouraging pediatric medical device research

(a)

Contact point for available funding

Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended—

(1)

in paragraph (21), by striking and after the semicolon at the end;

(2)

in paragraph (22), by striking the period at the end and inserting ; and; and

(3)

by inserting after paragraph (22) the following:

(23)

shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.

.

(b)

Plan for pediatric medical device research

(1)

In general

Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Director of the National Institutes of Health, and the Director of the Agency for Healthcare Research and Quality, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a plan for expanding pediatric medical device research and development. In developing such plan, the Secretary of Health and Human Services shall consult with individuals and organizations with appropriate expertise in pediatric medical devices.

(2)

Contents

The plan under paragraph (1) shall include—

(A)

the current status of federally funded pediatric medical device research;

(B)

any gaps in such research, which may include a survey of pediatric medical providers regarding unmet pediatric medical device needs, as needed; and

(C)

a research agenda for improving pediatric medical device development and Food and Drug Administration clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and effectiveness of pediatric medical devices.

305.

Demonstration grants for improving pediatric device availability

(a)

In general

(1)

Request for proposals

Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development.

(2)

Determination on grants or contracts

Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section.

(b)

Application

A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require.

(c)

Use of funds

A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by—

(1)

encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;

(2)

mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;

(3)

connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;

(4)

assessing the scientific and medical merit of proposed pediatric device projects; and

(5)

providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section.

(d)

Coordination

(1)

National institutes of health

Each consortium that receives a grant or contract under this section shall—

(A)

coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and

(B)

provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest.

(2)

Food and drug administration

Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use.

(3)

Effectiveness and outcomes

Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium.

(e)

Authorization of appropriations

There are authorized to be appropriated to carry out this section $6,000,000 for each of fiscal years 2008 through 2012.

306.

Amendments to office of pediatric therapeutics and pediatric advisory committee

(a)

Office of Pediatric Therapeutics

Section 6(b) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by inserting , including increasing pediatric access to medical devices after pediatric issues.

(b)

Pediatric Advisory Committee

Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—

(1)

in subsection (a), by inserting (including drugs and biological products) and medical devices after therapeutics; and

(2)

in subsection (b)—

(A)

in paragraph (1), by inserting (including drugs and biological products) and medical devices after therapeutics; and

(B)

in paragraph (2)—

(i)

in subparagraph (A), by striking and 505B and inserting 505B, 510(k), 515, and 520(m);

(ii)

by striking subparagraph (B) and inserting the following:

(B)

identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;

; and

(iii)

in subparagraph (C), by inserting (including drugs and biological products) and medical devices after therapeutics.

307.

Postmarket surveillance

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended—

(1)

by amending the section heading and designation to read as follows:

522.

Postmarket surveillance

;

(2)

by striking subsection (a) and inserting the following:

(a)

Postmarket surveillance

(1)

In general

(A)

Conduct

The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device—

(i)

the failure of which would be reasonably likely to have serious adverse health consequences;

(ii)

that is expected to have significant use in pediatric populations; or

(iii)

that is intended to be—

(I)

implanted in the human body for more than 1 year; or

(II)

a life-sustaining or life-supporting device used outside a device user facility.

(B)

Condition

The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii).

(2)

Rule of construction

The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the Act or regulations issued under this Act.

; and

(3)

in subsection (b)—

(A)

by striking (b) Surveillance Approval.—Each and inserting the following:

(b)

Surveillance approval

(1)

In general

Each

;

(B)

by striking The Secretary, in consultation and inserting Except as provided in paragraph (2), the Secretary, in consultation;

(C)

by striking Any determination and inserting Except as provided in paragraph (2), any determination; and

(D)

by adding at the end the following:

(2)

Longer surveillance for pediatric devices

The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.

(c)

Dispute resolution

A manufacturer may request review under section 562 of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed necessary to protect the public health.

.

IV

Pediatric Research Equity Act of 2007

401.

Short title

This title may be cited as the Pediatric Research Equity Act of 2007.

402.

Reauthorization of Pediatric Research Equity Act

(a)

In general

Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows:

505B.

Research into pediatric uses for drugs and biological products

(a)

New drugs and biological products

(1)

In general

A person that submits, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, an application (or supplement to an application)—

(A)

under section 505 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, or

(B)

under section 351 of the Public Health Service Act (42 U.S.C. 262) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration,

shall submit with the application the assessments described in paragraph (2).
(2)

Assessments

(A)

In general

The assessments referred to in paragraph (1) shall contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate—

(i)

to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant pediatric subpopulations; and

(ii)

to support dosing and administration for each pediatric subpopulation for which the drug or the biological product is safe and effective.

(B)

Similar course of disease or similar effect of drug or biological product

(i)

In general

If the course of the disease and the effects of the drug are sufficiently similar in adults and pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies.

(ii)

Extrapolation between age groups

A study may not be needed in each pediatric age group if data from one age group can be extrapolated to another age group.

(iii)

Information on extrapolation

A brief documentation of the scientific data supporting the conclusion under clauses (i) and (ii) shall be included in any pertinent reviews for the application under section 505 of this Act or section 351 of the Public Health Service Act (42 U.S.C. 262).

(3)

Deferral

(A)

In general

On the initiative of the Secretary or at the request of the applicant, the Secretary may defer submission of some or all assessments required under paragraph (1) until a specified date after approval of the drug or issuance of the license for a biological product if—

(i)

the Secretary finds that—

(I)

the drug or biological product is ready for approval for use in adults before pediatric studies are complete;

(II)

pediatric studies should be delayed until additional safety or effectiveness data have been collected; or

(III)

there is another appropriate reason for deferral; and

(ii)

the applicant submits to the Secretary—

(I)

certification of the grounds for deferring the assessments;

(II)

a description of the planned or ongoing studies;

(III)

evidence that the studies are being conducted or will be conducted with due diligence and at the earliest possible time; and

(IV)

a timeline for the completion of such studies.

(B)

Annual review

(i)

In general

On an annual basis following the approval of a deferral under subparagraph (A), the applicant shall submit to the Secretary the following information:

(I)

Information detailing the progress made in conducting pediatric studies.

(II)

If no progress has been made in conducting such studies, evidence and documentation that such studies will be conducted with due diligence and at the earliest possible time.

(ii)

Public availability

The information submitted through the annual review under clause (i) shall promptly be made available to the public in an easily accessible manner, including through the Web site of the Food and Drug Administration.

(4)

Waivers

(A)

Full waiver

On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments for a drug or biological product under this subsection if the applicant certifies and the Secretary finds that—

(i)

necessary studies are impossible or highly impracticable (because, for example, the number of patients is so small or the patients are geographically dispersed);

(ii)

there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups; or

(iii)

the drug or biological product—

(I)

does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients; and

(II)

is not likely to be used in a substantial number of pediatric patients.

(B)

Partial waiver

On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments for a drug or biological product under this subsection with respect to a specific pediatric age group if the applicant certifies and the Secretary finds that—

(i)

necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed);

(ii)

there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group;

(iii)

the drug or biological product—

(I)

does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and

(II)

is not likely to be used by a substantial number of pediatric patients in that age group; or

(iv)

the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed.

(C)

Pediatric formulation not possible

If a waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration.

(D)

Labeling requirement

If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product.

(b)

Marketed drugs and biological products

(1)

In general

After providing notice in the form of a letter (that, for a drug approved under section 505, references a declined written request under section 505A for a labeled indication which written request is not referred under section 505A(n)(1)(A) to the Foundation of the National Institutes of Health for the pediatric studies), the Secretary may (by order in the form of a letter) require the sponsor or holder of an approved application for a drug under section 505 or the holder of a license for a biological product under section 351 of the Public Health Service Act to submit by a specified date the assessments described in subsection (a)(2), if the Secretary finds that—

(A)
(i)

the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and

(ii)

adequate pediatric labeling could confer a benefit on pediatric patients;

(B)

there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients for 1 or more of the claimed indications; or

(C)

the absence of adequate pediatric labeling could pose a risk to pediatric patients.

(2)

Waivers

(A)

Full waiver

At the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments under this subsection if the applicant certifies and the Secretary finds that—

(i)

necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed); or

(ii)

there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups.

(B)

Partial waiver

At the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments under this subsection with respect to a specific pediatric age group if the applicant certifies and the Secretary finds that—

(i)

necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed);

(ii)

there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group;

(iii)
(I)

the drug or biological product—

(aa)

does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and

(bb)

is not likely to be used in a substantial number of pediatric patients in that age group; and

(II)

the absence of adequate labeling could not pose significant risks to pediatric patients; or

(iv)

the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed.

(C)

Pediatric formulation not possible

If a waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration.

(D)

Labeling requirement

If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product.

(3)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.

(c)

Meaningful therapeutic benefit

For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological product shall be considered to represent a meaningful therapeutic benefit over existing therapies if the Secretary determines that—

(1)

if approved, the drug or biological product could represent an improvement in the treatment, diagnosis, or prevention of a disease, compared with marketed products adequately labeled for that use in the relevant pediatric population; or

(2)

the drug or biological product is in a class of products or for an indication for which there is a need for additional options.

(d)

Submission of assessments

If a person fails to submit an assessment described in subsection (a)(2), or a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b)—

(1)

the drug or biological product that is the subject of the assessment or request may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303); but

(2)

the failure to submit the assessment or request shall not be the basis for a proceeding—

(A)

to withdraw approval for a drug under section 505(e); or

(B)

to revoke the license for a biological product under section 351 of the Public Health Service Act.

(e)

Meetings

Before and during the investigational process for a new drug or biological product, the Secretary shall meet at appropriate times with the sponsor of the new drug or biological product to discuss—

(1)

information that the sponsor submits on plans and timelines for pediatric studies; or

(2)

any planned request by the sponsor for waiver or deferral of pediatric studies.

(f)

Review of pediatric plans, assessments, deferrals, and waivers

(1)

Review

Beginning not later than 30 days after the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall utilize the internal committee established under section 505C to provide consultation to reviewing divisions on all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required under this section and all deferral and waiver requests granted pursuant to this section.

(2)

Activity by Committee

The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee.

(3)

Documentation of Committee Action

For each drug or biological product, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (4) or (5), which members of the committee participated in such activity.

(4)

Review of pediatric plans, assessments, deferrals, and waivers

Consultation on pediatric plans and assessments by the committee referred to in paragraph (1) pursuant to this section shall occur prior to approval of an application or supplement for which a pediatric assessment is required under this section. The committee shall review all requests for deferrals and waivers from the requirement to submit a pediatric assessment granted under this section and shall provide recommendations as needed to reviewing divisions, including with respect to whether such a supplement, when submitted, shall be considered for priority review.

(5)

Retrospective review of pediatric assessments, deferrals, and waivers

Not later than 1 year after the date of the enactment of the Pediatric Research Equity Act of 2007, the committee referred to in paragraph (1) shall conduct a retrospective review and analysis of a representative sample of assessments submitted and deferrals and waivers approved under this section since the enactment of the Pediatric Research Equity Act of 2003. Such review shall include an analysis of the quality and consistency of pediatric information in pediatric assessments and the appropriateness of waivers and deferrals granted. Based on such review, the Secretary shall issue recommendations to the review divisions for improvements and initiate guidance to industry related to the scope of pediatric studies required under this section.

(6)

Tracking of assessments and labeling changes

The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration—

(A)

the number of assessments conducted under this section;

(B)

the specific drugs and biological products and their uses assessed under this section;

(C)

the types of assessments conducted under this section, including trial design, the number of pediatric patients studied, and the number of centers and countries involved;

(D)

the total number of deferrals requested and granted under this section and, if granted, the reasons for such deferrals, the timeline for completion, and the number completed and pending by the specified date, as outlined in subsection (a)(3);

(E)

the number of waivers requested and granted under this section and, if granted, the reasons for the waivers;

(F)

the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons any such formulation was not developed;

(G)

the labeling changes made as a result of assessments conducted under this section;

(H)

an annual summary of labeling changes made as a result of assessments conducted under this section for distribution pursuant to subsection (h)(2);

(I)

an annual summary of information submitted pursuant to subsection (a)(3)(B); and

(J)

the number of times the committee referred to in paragraph (1) made a recommendation to the Secretary under paragraph (4) regarding priority review, the number of times the Secretary followed or did not follow such a recommendation, and, if not followed, the reasons why such a recommendation was not followed.

(g)

Labeling changes

(1)

Dispute resolution

(A)

Request for labeling change and failure to agree

If, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, the Commissioner determines that a sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application or supplement, not later than 180 days after the date of the submission of the application or supplement—

(i)

the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and

(ii)

if the sponsor does not agree within 30 days after the Commissioner’s request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.

(B)

Action by the pediatric advisory committee

Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—

(i)

review the pediatric study reports; and

(ii)

make a recommendation to the Commissioner concerning appropriate labeling changes, if any.

(C)

Consideration of recommendations

The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application or supplement to make any labeling changes that the Commissioner determines to be appropriate.

(D)

Misbranding

If the sponsor of the application or supplement, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application or supplement to be misbranded.

(E)

No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(2)

Other labeling changes

If, on or after the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary makes a determination that a pediatric assessment conducted under this section does or does not demonstrate that the drug that is the subject of such assessment is safe and effective in pediatric populations or subpopulations, including whether such assessment results are inconclusive, the Secretary shall order the label of such product to include information about the results of the assessment and a statement of the Secretary’s determination.

(h)

Dissemination of pediatric information

(1)

In general

Not later than 210 days after the date of submission of a pediatric assessment under this section, the Secretary shall make available to the public in an easily accessible manner the medical, statistical, and clinical pharmacology reviews of such pediatric assessments, and shall post such assessments on the Web site of the Food and Drug Administration.

(2)

Dissemination of information regarding labeling changes

Beginning on the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall require that the sponsors of the assessments that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(H) distribute such information to physicians and other health care providers.

(3)

Effect of subsection

Nothing in this subsection shall alter or amend section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.

(i)

Adverse event reporting

(1)

Reporting in year one

Beginning on the date of the enactment of the Pediatric Research Equity Act of 2007, during the one-year period beginning on the date a labeling change is made pursuant to subsection (g), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics. In considering such reports, the Director of such Office shall provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this Act in response to such reports.

(2)

Reporting in subsequent years

Following the one-year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.

(3)

Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary.

(j)

Scope of authority

Nothing in this section provides to the Secretary any authority to require a pediatric assessment of any drug or biological product, or any assessment regarding other populations or uses of a drug or biological product, other than the pediatric assessments described in this section.

(k)

Orphan drugs

Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for an indication for which orphan designation has been granted under section 526.

(l)

Institute of Medicine study

(1)

In general

Not later than three years after the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall contract with the Institute of Medicine to conduct a study and report to Congress regarding the pediatric studies conducted pursuant to this section or precursor regulations since 1997 and labeling changes made as a result of such studies.

(2)

Content of study

The study under paragraph (1) shall review and assess the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, the number and type of pediatric adverse events, and ethical issues in pediatric clinical trials.

(3)

Representative sample

The Institute of Medicine may devise an appropriate mechanism to review a representative sample of studies conducted pursuant to this section from each review division within the Center for Drug Evaluation and Research in order to make the requested assessment.

(m)

Integration with other pediatric studies

The authority under this section shall remain in effect so long as an application subject to this section may be accepted for filing by the Secretary on or before the date specified in section 505A(q).

.

(b)

Applicability

(1)

In general

Notwithstanding subsection (h) of section 505B of the Federal Food, Drug and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, a pending assessment, including a deferred assessment, required under such section 505B shall be deemed to have been required under section 505B of the Federal Food, Drug and Cosmetic Act as in effect on or after the date of the enactment of this Act.

(2)

Certain assessments and waiver requests

An assessment pending on or after the date that is 1 year prior to the date of the enactment of this Act shall be subject to the tracking and disclosure requirements established under such section 505B, as in effect on or after such date of enactment, except that any such assessments submitted or waivers of such assessments requested before such date of enactment shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such section 505B.

403.

Establishment of internal committee

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following:

505C.

Internal committee for review of pediatric plans, assessments, deferrals, and waivers

The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 505A(f) and 505B(f). Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry, and other individuals designated by the Secretary.

.

404.

Government Accountability Office report

Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the Secretary of Health and Human Services, shall submit to the Congress a report that addresses the effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are tested and properly labeled. Such report shall include—

(1)

the number and importance of drugs and biological products for children that are being tested as a result of the amendments made by this title and title V and the importance for children, health care providers, parents, and others of labeling changes made as a result of such testing;

(2)

the number and importance of drugs and biological products for children that are not being tested for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of testing;

(3)

the number of drugs and biological products for which testing is being done and labeling changes required, including the date labeling changes are made and which labeling changes required the use of the dispute resolution process established pursuant to the amendments made by this title, together with a description of the outcomes of such process, including a description of the disputes and the recommendations of the Pediatric Advisory Committee;

(4)

any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C. 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation; and

(5)
(A)

the efforts made by the Secretary to increase the number of studies conducted in the neonate population; and

(B)

the results of those efforts, including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe.

V

Best Pharmaceuticals for Children Act of 2007

501.

Short title

This title may be cited as the Best Pharmaceuticals for Children Act of 2007.

502.

Reauthorization of Best Pharmaceuticals for Children Act

(a)

Pediatric studies of drugs

(1)

In general

Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read as follows:

505A.

Pediatric studies of drugs

(a)

Definitions

As used in this section, the term pediatric studies or studies means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.

(b)

Market exclusivity for new drugs

(1)

In general

Except as provided in paragraph (2), if, prior to approval of an application that is submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(3)—

(A)
(i)
(I)

the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or

(II)

the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and

(ii)

if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and

(B)
(i)

if the drug is the subject of—

(I)

a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or

(II)

a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505,

the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or
(ii)

if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions).

(2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.

(c)

Market exclusivity for already-marketed drugs

(1)

In general

Except as provided in paragraph (2), if the Secretary determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved application under section 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies), the holder agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(3)—

(A)
(i)
(I)

the period referred to in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or

(II)

the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and

(ii)

if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and

(B)
(i)

if the drug is the subject of—

(I)

a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or

(II)

a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505,

the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)(ii) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or
(ii)

if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions).

(2)

Exception

The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(3) is made later than 9 months prior to the expiration of such period.

(d)

Conduct of pediatric studies

(1)

Request for studies

(A)

In general

The Secretary may, after consultation with the sponsor of an application for an investigational new drug under section 505(i), the sponsor of an application for a new drug under section 505(b)(1), or the holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such studies.

(B)

Single written request

A single written request—

(i)

may relate to more than one use of a drug; and

(ii)

may include uses that are both approved and unapproved.

(2)

Written request for pediatric studies

(A)

Request and response

(i)

In general

If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the applicant or holder to act on the request by—

(I)

indicating when the pediatric studies will be initiated, if the applicant or holder agrees to the request; or

(II)

indicating that the applicant or holder does not agree to the request and stating the reasons for declining the request.

(ii)

Disagree with request

If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed.

(B)

Adverse event reports

An applicant or holder that, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, agrees to the request for such studies shall provide the Secretary, at the same time as the submission of the reports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such reports.

(3)

Meeting the studies requirement

Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.

(4)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.

(e)

Notice of determinations on studies requirement

(1)

In general

The Secretary shall publish a notice of any determination, made on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary’s determination regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c).

(2)

Identification of certain drugs

The Secretary shall publish a notice identifying any drug for which, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within one year after the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such one year period.

(f)

Internal review of written requests and pediatric studies

(1)

Internal review

The Secretary shall utilize the internal review committee established under section 505C to review all written requests issued on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, in accordance with paragraph (2).

(2)

Review of written requests

The committee referred to in paragraph (1) shall review all written requests issued pursuant to this section prior to being issued.

(3)

Review of pediatric studies

The committee referred to in paragraph (1) may review studies conducted pursuant to this section to make a recommendation to the Secretary whether to accept or reject such reports under subsection (d)(3).

(4)

Activity by Committee

The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee.

(5)

Documentation of Committee Action

For each drug, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (2) or (3), which members of the committee participated in such activity.

(6)

Tracking pediatric studies and labeling changes

The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public, in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration—

(A)

the number of studies conducted under this section and under section 409I of the Public Health Service Act;

(B)

the specific drugs and drug uses, including labeled and off-labeled indications, studied under such sections;

(C)

the types of studies conducted under such sections, including trial design, the number of pediatric patients studied, and the number of centers and countries involved;

(D)

the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons such formulations were not developed;

(E)

the labeling changes made as a result of studies conducted under such sections;

(F)

an annual summary of labeling changes made as a result of studies conducted under such sections for distribution pursuant to subsection (k)(2); and

(G)

information regarding reports submitted on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007.

(g)

Limitations

Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b) or (c) has already been applied—

(1)

may receive an additional six-month period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other requirements under this section are satisfied, except that such drug may not receive any additional such period under subsection (c)(1)(B); and

(2)

may not receive any additional such period under subsection (c)(1)(A)(ii).

(h)

Relationship to pediatric research requirements

Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section.

(i)

Labeling changes

(1)

Priority status for pediatric applications and supplements

Any application or supplement to an application under section 505 proposing a labeling change as a result of any pediatric study conducted pursuant to this section—

(A)

shall be considered to be a priority application or supplement; and

(B)

shall be subject to the performance goals established by the Commissioner for priority drugs.

(2)

Dispute resolution

(A)

Request for labeling change and failure to agree

If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Commissioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application—

(i)

the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and

(ii)

if the sponsor of the application does not agree within 30 days after the Commissioner’s request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.

(B)

Action by the pediatric advisory committee

Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—

(i)

review the pediatric study reports; and

(ii)

make a recommendation to the Commissioner concerning appropriate labeling changes, if any.

(C)

Consideration of recommendations

The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor of the application to make any labeling change that the Commissioner determines to be appropriate.

(D)

Misbranding

If the sponsor of the application, within 30 days after receiving a request under subparagraph (C), does not agree to make a labeling change requested by the Commissioner, the Commissioner may deem the drug that is the subject of the application to be misbranded.

(E)

No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under this Act when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(j)

Other labeling changes

If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary determines that a pediatric study conducted under this section does or does not demonstrate that the drug that is the subject of the study is safe and effective, including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary shall order the labeling of such product to include information about the results of the study and a statement of the Secretary’s determination.

(k)

Dissemination of pediatric information

(1)

In general

Not later than 210 days after the date of submission of a report on a pediatric study under this section, the Secretary shall make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under subsection (b) or (c).

(2)

Dissemination of information regarding labeling changes

Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(3)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers.

(3)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.

(l)

Adverse event reporting

(1)

Reporting in year one

Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, during the one-year period beginning on the date a labeling change is approved pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was received) are referred to the Office of Pediatric Therapeutics established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations of such Committee regarding whether the Secretary should take action under this Act in response to such reports.

(2)

Reporting in subsequent years

Following the one-year period described in paragraph (1), the Secretary shall, as appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee regarding whether the Secretary should take action in response to such reports.

(3)

Effect

The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary.

(m)

Clarification of Interaction of Market Exclusivity Under This Section and Market Exclusivity Awarded to An Applicant for Approval of A Drug Under Section 505(j)

If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 505(j) entitled to the 180-day period under that section loses a portion of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be extended from—

(1)

the date on which the 180-day period would have expired by the number of days of the overlap, if the 180-day period would, but for the application of this subsection, expire after the 6-month exclusivity period; or

(2)

the date on which the 6-month exclusivity period expires, by the number of days of the overlap if the 180-day period would, but for the application of this subsection, expire during the six-month exclusivity period.

(n)

Referral if pediatric studies not completed

(1)

In general

Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, if pediatric studies of a drug have not been completed under subsection (d) and if the Secretary, through the committee established under section 505C, determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following:

(A)

For a drug for which a listed patent has not expired, make a determination regarding whether an assessment shall be required to be submitted under section 505B(b). Prior to making such a determination, the Secretary may not take more than 30 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such certification to initiate and fund all of the studies in the written request in their entirety within the timeframes specified within the written request. Only if the Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 505B(b) for such drug.

(B)

For a drug that has no listed patents or has 1 or more listed patents that have expired, the Secretary shall refer the drug for inclusion on the list established under section 409I of the Public Health Service Act for the conduct of studies.

(2)

Public notice

The Secretary shall give the public notice of a decision under paragraph (1)(A) not to require an assessment under section 505B and the basis for such decision.

(3)

Effect of subsection

Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.

(o)

Prompt approval of drugs under section 505(j) when pediatric information is added to labeling

(1)

General rule

A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).

(2)

Labeling

Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(F), the Secretary may require that the labeling of a drug approved under section 505(j) that omits a pediatric indication or other aspect of labeling as described in paragraph (1) include—

(A)

a statement that, because of marketing exclusivity for a manufacturer—

(i)

the drug is not labeled for pediatric use; or

(ii)

in the case of a drug for which there is an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and

(B)

a statement of any appropriate pediatric contraindications, warnings, or precautions that the Secretary considers necessary.

(3)

Preservation of pediatric exclusivity and other provisions

This subsection does not affect—

(A)

the availability or scope of exclusivity under this section;

(B)

the availability or scope of exclusivity under section 505 for pediatric formulations;

(C)

the question of the eligibility for approval of any application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(F); or

(D)

except as expressly provided in paragraphs (1) and (2), the operation of section 505.

(p)

Institute of Medicine study

Not later than 3 years after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute of Medicine to conduct a study and report to Congress regarding the written requests made and the studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to review a representative sample of requests made and studies conducted pursuant to this section in order to conduct such study. Such study shall—

(1)

review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c);

(2)

review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and labeling changes made as a result of such studies;

(3)

review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, and ethical issues in pediatric clinical trials;

(4)

review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 505B; and

(5)

make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics.

(q)

Sunset

A drug may not receive any 6-month period under subsection (b) or (c) unless—

(1)

on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug;

(2)

on or before October 1, 2012, an application for the drug is accepted for filing under section 505(b); and

(3)

all requirements of this section are met.

.

(2)

Applicability

(A)

In general

The amendment made by this subsection shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment of this Act.

(B)

Certain written requests

A written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been accepted and for which no determination under subsection (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on or after the date of the enactment of this Act.

(b)

Program for Pediatric Studies of Drugs

Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended to read as follows:

409I.

Program for pediatric studies of drugs

(a)

List of priority issues in pediatric therapeutics

(1)

In general

Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that require study. The list shall be revised every three years.

(2)

Consideration of available information

In developing and prioritizing the list under paragraph (1), the Secretary shall consider—

(A)

therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;

(B)

particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and

(C)

the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators.

(b)

Pediatric studies and research

The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.

(c)

Process for proposed pediatric study requests and labeling changes

(1)

Submission of proposed pediatric study request

The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—

(A)
(i)

there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act; or

(ii)

there is a submitted application that could be approved under the criteria of such section; and

(B)

there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and

(C)

additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.

(2)

Written request to holders of approved applications for drugs lacking exclusivity

The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) of section 505A of such Act, including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.

(3)

Requests for proposals

If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b).

(4)

Disqualification

A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3).

(5)

Contracts, grants, or other funding mechanisms

A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.

(6)

Reporting of studies

(A)

In general

On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued.

(B)

Availability of reports

Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs.

(C)

Action by Commissioner

The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7).

(7)

Requests for labeling change

During the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—

(A)

review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied;

(B)

negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and

(C)
(i)

place in the public docket file a copy of the report and of any requested labeling changes; and

(ii)

publish in the Federal Register and through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes.

(8)

Dispute resolution

(A)

Referral to pediatric advisory committee

If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.

(B)

Action by the pediatric advisory committee

Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—

(i)

review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and

(ii)

make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.

(9)

FDA determination

Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate.

(10)

Failure to agree

If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act.

(11)

No effect on authority

Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.

(d)

Dissemination of pediatric information

Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress.

(e)

Authorization of appropriations

(1)

In general

There are authorized to be appropriated to carry out this section—

(A)

$200,000,000 for fiscal year 2008; and

(B)

such sums as are necessary for each of the four succeeding fiscal years.

(2)

Availability

Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.

.

(c)

Foundation for the national institutes of health

Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of this Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)’ and inserting and studies for which the Secretary issues a certification in the affirmative under section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act.

(d)

Continuation of operation of committee

Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by adding at the end the following new subsection:

(d)

Continuation of operation of committee

Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007.

.

(e)

Pediatric subcommittee of the oncologic drugs advisory committee

Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

in subparagraph (B), by striking “and” after the semicolon;

(ii)

in subparagraph (C), by striking the period at the end and inserting “; and”; and

(iii)

by adding at the end the following new subparagraph:

(D)

provide recommendations to the internal review committee created under section 505B(f) of the Federal Food, Drug, and Cosmetic Act regarding the implementation of amendments to sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act with respect to the treatment of pediatric cancers.

; and

(B)

by adding at the end the following new paragraph:

(3)

Continuation of operation of subcommittee

Notwithstanding section 14 of the Federal Advisory Committee Act, the Subcommittee shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007.

; and

(2)

in subsection (d), by striking “2003” and inserting “2009”.

(f)

Effective date and limitation for rule relating to toll-free number for adverse events on labeling for human drug products

(1)

In general

Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the “Administrative Procedure Act”) and any other provision of law, the proposed rule issued by the Commissioner of Food and Drugs entitled “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products,” 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on January 1, 2008, unless such Commissioner issues the final rule before such date.

(2)

Limitation

The proposed rule that takes effect under subsection (a), or the final rule described under subsection (a), shall, notwithstanding section 17(a) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply to a drug—

(A)

for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);

(B)

that is not described under section 503(b)(1) of such Act (21 U.S.C. 353(b)(1)); and

(C)

the packaging of which includes a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug.

503.

Training of pediatric pharmacologists

(a)

Investment in tomorrow's pediatric researchers

Section 452G(2) of the Public Health Service Act (42 U.S.C. 285g–10(2)) is amended by adding before the period at the end the following: , including pediatric pharmacological research.

(b)

Pediatric research loan repayment program

Section 487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) is amended by inserting including pediatric pharmacological research, after pediatric research,.

VI

Reagan-Udall Foundation

601.

The Reagan-Udall Foundation for the Food and Drug Administration

(a)

In general

Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:

I

Reagan-Udall Foundation for the Food and Drug Administration

770.

Establishment and functions of the Foundation

(a)

In general

A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this subchapter as the Foundation) shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e). The Foundation shall not be an agency or instrumentality of the United States Government.

(b)

Purpose of Foundation

The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

(c)

Duties of the Foundation

The Foundation shall—

(1)

taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety;

(2)

establish goals and priorities in order to meet the unmet needs identified in paragraph (1);

(3)

in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;

(4)

award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) of the Internal Revenue Code (and exempt from tax under section 501(a) of such Code), and industry, to efficiently and effectively advance the goals and priorities established under paragraph (2);

(5)

recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);

(6)

release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);

(7)

ensure that—

(A)

action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;

(B)

action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and

(C)

executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);

(8)

provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency's public health mission;

(9)

conduct annual assessments of the unmet needs identified in paragraph (1); and

(10)

carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.

(d)

Board of directors

(1)

Establishment

(A)

In general

The Foundation shall have a Board of Directors (referred to in this subchapter as the Board), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.

(B)

Ex officio members

The ex officio members of the Board shall be the following individuals or their designees:

(i)

The Commissioner.

(ii)

The Director of the National Institutes of Health.

(iii)

The Director of the Centers for Disease Control and Prevention.

(iv)

The Director of the Agency for Healthcare Research and Quality.

(C)

Appointed members

(i)

In general

The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members—

(I)

4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;

(II)

3 shall be representatives of academic research organizations;

(III)

2 shall be representatives of patient or consumer advocacy organizations;

(IV)

1 shall be a representative of health care providers; and

(V)

4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.

(ii)

Requirements

(I)

Expertise

The ex officio members shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.

(II)

Federal employees

No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B).

(D)

Initial meeting

(i)

In general

Not later than 30 days after the date of the enactment of this subchapter, the Secretary shall convene a meeting of the ex officio members of the Board to—

(I)

incorporate the Foundation; and

(II)

appoint the members of the Board in accordance with subparagraph (C).

(ii)

Service of ex officio members

Upon the appointment of the members of the Board under clause (i)(II)—

(I)

the terms of service of the Director of the Centers for Disease Control and Prevention and of the Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall terminate; and

(II)

the Commissioner and the Director of the National Institutes of Health shall continue to serve as ex officio members of the Board, but shall be nonvoting members.

(iii)

Chair

The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.

(2)

Duties of board

The Board shall—

(A)

establish bylaws for the Foundation that—

(i)

are published in the Federal Register and available for public comment;

(ii)

establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;

(iii)

establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient of donated funds;

(iv)

establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under section 208 of title 18, United States Code;

(v)

establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;

(vi)

specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;

(vii)

specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;

(viii)

establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;

(ix)

establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;

(x)

specify a process for annual Board review of the operations of the Foundation; and

(xi)

establish specific duties of the Executive Director;

(B)

prioritize and provide overall direction to the activities of the Foundation;

(C)

evaluate the performance of the Executive Director; and

(D)

carry out any other necessary activities regarding the functioning of the Foundation.

(3)

Terms and vacancies

(A)

Term

The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4 years, except that the terms of offices for the initial appointed members of the Board shall expire on a staggered basis as determined by the ex officio members.

(B)

Vacancy

Any vacancy in the membership of the Board—

(i)

shall not affect the power of the remaining members to execute the duties of the Board; and

(ii)

shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.

(C)

Partial term

If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

(D)

Serving past term

A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.

(4)

Compensation

Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.

(e)

Incorporation

The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.

(f)

Nonprofit status

In carrying out subsection (b), the Board shall establish such policies and bylaws under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be necessary to ensure that the Foundation maintains status as an organization that—

(1)

is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and

(2)

is, under subsection (a) of such section, exempt from taxation.

(g)

Executive Director

(1)

In general

The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.

(2)

Compensation

The compensation of the Executive Director shall be fixed by the Board but shall not be greater than the compensation of the Commissioner.

(h)

Administrative powers

In carrying out this subchapter, the Board, acting through the Executive Director, may—

(1)

adopt, alter, and use a corporate seal, which shall be judicially noticed;

(2)

hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;

(3)

prescribe the manner in which—

(A)

real or personal property of the Foundation is acquired, held, and transferred;

(B)

general operations of the Foundation are to be conducted; and

(C)

the privileges granted to the Board by law are exercised and enjoyed;

(4)

with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;

(5)

enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;

(6)

hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);

(7)

enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;

(8)

modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this subchapter;

(9)

take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;

(10)

sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;

(11)

appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; and

(12)

exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this subchapter.

(i)

Acceptance of funds from other sources

The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.

(j)

Service of Federal employees

Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.

(k)

Detail of government employees; Fellowships

(1)

Detail from Federal agencies

Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.

(2)

Voluntary service; acceptance of Federal employees

(A)

Foundation

The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.

(B)

Food and Drug Administration

The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in section 708.

(l)

Annual reports

(1)

Reports to Foundation

Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.

(2)

Report to Congress and the FDA

Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that—

(A)

describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;

(B)

provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; and

(C)

provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.

(m)

Separation of funds

The Executive Director shall ensure that the funds received from the Treasury are held in separate accounts from funds received from entities under subsection (i).

(n)

Funding

From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $500,000 and not more than $1,250,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).

.

(b)

Other Foundation provisions

Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as amended by subsection (a)) is amended by adding at the end the following:

771.

Location of Foundation

The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.

772.

Activities of the Food and Drug Administration

(a)

In general

The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 770(l)(2).

(b)

Report to Congress

Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 770(l)(2) and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.

(c)

Extramural grants

The provisions of this subchapter and section 566 shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after the date of the enactment of this subchapter.

.

(c)

Conforming amendment

Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the end the following: Any such fellowships and training programs under this section or under section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services..

602.

Office of the Chief Scientist

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

910.

Office of the chief scientist

(a)

Establishment; appointment

The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.

(b)

Duties of the Office

The Office of the Chief Scientist shall—

(1)

oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;

(2)

track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;

(3)

develop and advocate for a budget to support intramural research;

(4)

develop a peer review process by which intramural research can be evaluated;

(5)

identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include—

(A)

representatives of each of the centers and the science-based offices within the Office of the Commissioner; and

(B)

experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and

(6)

develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review.

.

603.

Critical path public-private partnerships

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:

566.

Critical path public-private partnerships

(a)

Establishment

The Secretary, acting through the Commissioner of Food and Drugs, may enter into collaborative agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical Path Initiative of the Food and Drug Administration by developing innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.

(b)

Eligible Entity

In this section, the term eligible entity means an entity that meets each of the following:

(1)

The entity is—

(A)

an institution of higher education (as such term is defined in section 101 of the Higher Education Act of 1965) or a consortium of such institutions; or

(B)

an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such Code.

(2)

The entity has experienced personnel and clinical and other technical expertise in the biomedical sciences, which may include graduate training programs in areas relevant to priorities of the Critical Path Initiative.

(3)

The entity demonstrates to the Secretary’s satisfaction that the entity is capable of—

(A)

developing and critically evaluating tools, methods, and processes—

(i)

to increase efficiency, predictability, and productivity of medical product development; and

(ii)

to more accurately identify the benefits and risks of new and existing medical products;

(B)

establishing partnerships, consortia, and collaborations with health care practitioners and other providers of health care goods or services; pharmacists; pharmacy benefit managers and purchasers; health maintenance organizations and other managed health care organizations; health care insurers; government agencies; patients and consumers; manufacturers of prescription drugs, biological products, diagnostic technologies, and devices; and academic scientists; and

(C)

securing funding for the projects of a Critical Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private individuals.

(c)

Funding

The Secretary may not enter into a collaborative agreement under subsection (a) unless the eligible entity involved provides an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by any source of funding.

(d)

Annual Report

Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary, in collaboration with the parties to each Critical Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives—

(1)

reviewing the operations and activities of the Partnerships in the previous year; and

(2)

addressing such other issues relating to this section as the Secretary determines to be appropriate.

(e)

Definition

In this section, the term medical product includes a drug, a biological product as defined in section 351 of the Public Health Service Act, a device, and any combination of such products.

(f)

Authorization of Appropriations

To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2008 and such sums as may be necessary for each of fiscal years 2009 through 2012.

.

VII

Conflicts of interest

701.

Conflicts of interest

(a)

In general

Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting at the end the following:

712.

Conflicts of interest

(a)

Definitions

For purposes of this section:

(1)

Advisory committee

The term advisory committee means an advisory committee under the Federal Advisory Committee Act that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(2)

Financial interest

The term financial interest means a financial interest under section 208(a) of title 18, United States Code.

(b)

Appointments to advisory committees

(1)

Recruitment

(A)

In general

The Secretary shall—

(i)

develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;

(ii)

seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities; and

(iii)

take into account the advisory committees with the greatest number of vacancies.

(B)

Recruitment activities

The recruitment activities under subparagraph (A) may include—

(i)

advertising the process for becoming an advisory committee member at medical and scientific society conferences;

(ii)

making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and

(iii)

developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person who the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.

(2)

Evaluation and criteria

When considering a term appointment to an advisory committee, the Secretary shall review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in Government Act of 1978 for each individual under consideration for the appointment, so as to reduce the likelihood that an appointed individual will later require a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in subsection (c)(2) of this section for service on the committee at a meeting of the committee.

(c)

Disclosures; prohibitions on participation; waivers

(1)

Disclosure of financial interest

Prior to a meeting of an advisory committee regarding a particular matter (as that term is used in section 208 of title 18, United States Code), each member of the committee who is a full-time Government employee or special Government employee shall disclose to the Secretary financial interests in accordance with subsection (b) of such section 208.

(2)

Prohibitions and waivers on participation

(A)

In general

Except as provided under subparagraph (B), a member of an advisory committee may not participate with respect to a particular matter considered in an advisory committee meeting if such member (or an immediate family member of such member) has a financial interest that could be affected by the advice given to the Secretary with respect to such matter, excluding interests exempted in regulations issued by the Director of the Office of Government Ethics as too remote or inconsequential to affect the integrity of the services of the Government officers or employees to which such regulations apply.

(B)

Waiver

If the Secretary determines it necessary to afford the advisory committee essential expertise, the Secretary may grant a waiver of the prohibition in subparagraph (A) to permit a member described in such subparagraph to—

(i)

participate as a non-voting member with respect to a particular matter considered in a committee meeting; or

(ii)

participate as a voting member with respect to a particular matter considered in a committee meeting.

(C)

Limitation on waivers and other exceptions

(i)

Definition

For purposes of this subparagraph, the term exception means each of the following with respect to members of advisory committees:

(I)

A waiver under section 505(n)(4) (as in effect on the day before the date of the enactment of the Food and Drug Administration Amendments Act of 2007).

(II)

A written determination under section 208(b) of title 18, United States Code.

(III)

A written certification under section 208(b)(3) of such title.

(ii)

Determination of total number of members slots and member exceptions during fiscal year 2007

The Secretary shall determine—

(I)
(aa)

for each meeting held by any advisory committee during fiscal year 2007, the number of members who participated in the meeting; and

(bb)

the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the “total number of 2007 meeting slots”); and

(II)
(aa)

for each meeting held by any advisory committee during fiscal year 2007, the number of members who received an exception for the meeting; and

(bb)

the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the “total number of 2007 meeting exceptions”).

(iii)

Determination of percentage regarding exceptions during fiscal year 2007

The Secretary shall determine the percentage constituted by—

(I)

the total number of 2007 meeting exceptions; divided by

(II)

the total number of 2007 meeting slots.

(iv)

Limitation for fiscal years 2008 through 2012

The number of exceptions at the Food and Drug Administration for members of advisory committees for a fiscal year may not exceed the following:

(I)

For fiscal year 2008, 95 percent of the percentage determined under clause (iii) (referred to in this clause as the “base percentage”).

(II)

For fiscal year 2009, 90 percent of the base percentage.

(III)

For fiscal year 2010, 85 percent of the base percentage.

(IV)

For fiscal year 2011, 80 percent of the base percentage.

(V)

For fiscal year 2012, 75 percent of the base percentage.

(v)

Allocation of exceptions

The exceptions authorized under clause (iv) for a fiscal year may be allocated within the centers or other organizational units of the Food and Drug Administration as determined appropriate by the Secretary.

(3)

Disclosure of waiver

Notwithstanding section 107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the following shall apply:

(A)

15 or more days in advance

As soon as practicable, but (except as provided in subparagraph (B)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet Web site of the Food and Drug Administration—

(i)

the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination, certification, or waiver applies; and

(ii)

the reasons of the Secretary for such determination, certification, or waiver.

(B)

Less than 30 days in advance

In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 18, United States Code, or a waiver as referred to in paragraph (2)(B) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code) on the Internet Web site of the Food and Drug Administration, the information described in clauses (i) and (ii) of subparagraph (A) as soon as practicable after the Secretary makes such determination, certification, or waiver, but in no case later than the date of such meeting.

(d)

Public record

The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c)(3) (other than information exempted from disclosure under section 552 of title 5, United States Code, and section 552a of title 5, United States Code).

(e)

Annual report

Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report that describes—

(1)

with respect to the fiscal year that ended on September 30 of the previous year, the number of vacancies on each advisory committee, the number of nominees received for each committee, and the number of such nominees willing to serve;

(2)

with respect to such year, the aggregate number of disclosures required under subsection (c)(3) for each meeting of each advisory committee and the percentage of individuals to whom such disclosures did not apply who served on such committee for each such meeting;

(3)

with respect to such year, the number of times the disclosures required under subsection (c)(3) occurred under subparagraph (B) of such subsection; and

(4)

how the Secretary plans to reduce the number of vacancies reported under paragraph (1) during the fiscal year following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, including those who are classified by the Food and Drug Administration as academicians or practitioners.

(f)

Periodic review of guidance

Not less than once every 5 years, the Secretary shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary.

.

(b)

Conforming amendments

Section 505(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by—

(1)

striking paragraph (4); and

(2)

redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively.

(c)

Effective date

The amendments made by this section shall take effect on October 1, 2007.

VIII

Clinical trial databases

801.

Expanded clinical trial registry data bank

(a)

In general

Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by—

(1)

redesignating subsections (j) and (k) as subsections (k) and (l), respectively; and

(2)

inserting after subsection (i) the following:

(j)

Expanded clinical trial registry data bank

(1)

Definitions; requirement

(A)

Definitions

In this subsection:

(i)

Applicable clinical trial

The term applicable clinical trial means an applicable device clinical trial or an applicable drug clinical trial.

(ii)

applicable device clinical trial

The term applicable device clinical trial means—

(I)

a prospective clinical study of health outcomes comparing an intervention with a device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and

(II)

a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act.

(iii)

Applicable drug clinical trial

(I)

In general

The term applicable drug clinical trial means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of this Act.

(II)

Clinical investigation

For purposes of subclause (I), the term clinical investigation has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation).

(III)

Phase I

For purposes of subclause (I), the term phase I has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).

(iv)

Clinical trial information

The term clinical trial information means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).

(v)

Completion date

The term completion date means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

(vi)

Device

The term device means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act.

(vii)

Drug

The term drug means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act or a biological product as defined in section 351 of this Act.

(viii)

Ongoing

The term ongoing means, with respect to a clinical trial of a drug or a device and to a date, that—

(I)

1 or more patients is enrolled in the clinical trial; and

(II)

the date is before the completion date of the clinical trial.

(ix)

Responsible party

The term responsible party, with respect to a clinical trial of a drug or device, means—

(I)

the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or

(II)

the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.

(B)

Requirement

The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).

(2)

Expansion of clinical trial registry data bank with respect to clinical trial information

(A)

In general

(i)

Expansion of data bank

To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the registry data bank). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.

(ii)

Content

The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include—

(I)

descriptive information, including—

(aa)

a brief title, intended for the lay public;

(bb)

a brief summary, intended for the lay public;

(cc)

the primary purpose;

(dd)

the study design;

(ee)

for an applicable drug clinical trial, the study phase;

(ff)

study type;

(gg)

the primary disease or condition being studied, or the focus of the study;

(hh)

the intervention name and intervention type;

(ii)

the study start date;

(jj)

the expected completion date;

(kk)

the target number of subjects; and

(ll)

outcomes, including primary and secondary outcome measures;

(II)

recruitment information, including—

(aa)

eligibility criteria;

(bb)

gender;

(cc)

age limits;

(dd)

whether the trial accepts healthy volunteers;

(ee)

overall recruitment status;

(ff)

individual site status; and

(gg)

in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;

(III)

location and contact information, including—

(aa)

the name of the sponsor;

(bb)

the responsible party, by official title; and

(cc)

the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and

(IV)

administrative data (which the Secretary may make publicly available as necessary), including—

(aa)

the unique protocol identification number;

(bb)

other protocol identification numbers, if any; and

(cc)

the Food and Drug Administration IND/IDE protocol number and the record verification date.

(iii)

Modifications

The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information.

(B)

Format and structure

(i)

Searchable categories

The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:

(I)

The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.

(II)

The name of the intervention, including any drug or device being studied in the clinical trial.

(III)

The location of the clinical trial.

(IV)

The age group studied in the clinical trial, including pediatric subpopulations.

(V)

The study phase of the clinical trial.

(VI)

The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.

(VII)

The recruitment status of the clinical trial.

(VIII)

The National Clinical Trial number or other study identification for the clinical trial.

(ii)

Additional searchable category

Not later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.

(iii)

Other elements

The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.

(iv)

Format

The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.

(C)

Data submission

The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, the date of the enactment of the Food and Drug Administration Amendments Act of 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of subparagraph (A)(ii) not later than the later of—

(i)

90 days after such date of enactment;

(ii)

21 days after the first patient is enrolled in such clinical trial; or

(iii)

in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on such date of enactment, 1 year after such date of enactment.

(D)

Posting of data

(i)

Applicable drug clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission.

(ii)

Applicable device clinical trial

The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank—

(I)

not earlier than the date of clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or approval under section 515 or 520(m) of such Act, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date; or

(II)

for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.

(3)

Expansion of registry data bank to include results of clinical trials

(A)

Linking registry data bank to existing results

(i)

In general

Beginning not later than 90 days after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—

(I)

not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or

(II)

not later than 30 days after the results information described in clause (ii) becomes publicly available.

(ii)

Required information

(I)

FDA information

The Secretary shall ensure that the registry data bank includes links to the following information:

(aa)

If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.

(bb)

If an applicable drug clinical trial was conducted under section 505A or 505B of the Federal Food, Drug, and Cosmetic Act, a link to the posted Food and Drug Administration assessment of the results of such trial.

(cc)

Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.

(dd)

For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 505(l)(2) of the Federal Food, Drug, and Cosmetic Act.

(ee)

For an applicable device clinical trial, in the case of a premarket application under section 515 of the Federal Food, Drug, and Cosmetic Act, the detailed summary of information respecting the safety and effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of a report under section 510(k) of such Act, the section 510(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation).

(II)

NIH information

The Secretary shall ensure that the registry data bank includes links to the following information:

(aa)

Medline citations to any publications focused on the results of an applicable clinical trial.

(bb)

The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.

(iii)

Results for existing data bank entries

The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to enactment of the Food and Drug Administration Amendments Act of 2007, as available.

(B)

Inclusion of results

The Secretary, acting through the Director of NIH, shall—

(i)

expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the registry and results data bank);

(ii)

ensure that such results are made publicly available through the Internet;

(iii)

post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and

(iv)

in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.

(C)

Basic results

Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act:

(i)

Demographic and baseline characteristics of patient sample

A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.

(ii)

Primary and secondary outcomes

The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.

(iii)

Point of contact

A point of contact for scientific information about the clinical trial results.

(iv)

Certain agreements

Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.

(D)

Expanded registry and results data bank

(i)

Expansion by rulemaking

To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.

(ii)

Clinical trials

(I)

Approved products

The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for—

(aa)

each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; and

(bb)

each applicable device clinical trial for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act.

(II)

Unapproved products

The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for—

(aa)

an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure was sought or not); and

(bb)

an applicable device clinical trial for a device that is not cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act and not approved under section 515 or section 520(m) of such Act (whether clearance or approval was sought or not).

(iii)

Required elements

The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:

(I)

A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional.

(II)

A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional.

(III)

The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial.

(IV)

Such other categories as the Secretary determines appropriate.

(iv)

Results submission

The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine—

(I)

whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months;

(II)

whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and

(III)

in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account—

(aa)

the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and

(bb)

whether there should be a delay of submission when approval, licensure, or clearance will not be sought.

(v)

Additional provisions

The regulations under this subparagraph shall also establish—

(I)

a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank;

(II)

additional information on clinical trials and results that is written in nontechnical, understandable language for patients;

(III)

considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional;

(IV)

the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked;

(V)

a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and

(VI)

additions or modifications to the manner of reporting of the data elements established under subparagraph (C).

(vi)

Consideration of World Health Organization data set

The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph.

(vii)

Public meeting

The Secretary shall hold a public meeting no later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph.

(E)

Submission of results information

(i)

In general

Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—

(I)

the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or

(II)

the actual date of completion.

(ii)

Clinical trials described

An applicable clinical trial described in this clause is an applicable clinical trial subject to—

(I)

paragraph (2)(C); and

(II)
(aa)

subparagraph (C); or

(bb)

the regulations issued under subparagraph (D).

(iii)

Delayed submission of results with certification

If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause.

(iv)

Seeking initial approval of a drug or device

With respect to an applicable clinical trial that is completed before the drug is initially approved under section 505 of the Federal Food, Drug, and Cosmetic Act or initially licensed under section 351 of this Act, or the device is initially cleared under section 510(k) or initially approved under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515 or 520(m), as applicable.

(v)

Seeking approval of a new use for the drug or device

(I)

In general

With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act, licensing under section 351 of this Act, or clearance under section 510(k), or approval under section 515 or 520(m), of the Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date—

(aa)

the new use of the drug or device is approved under such section 505, licensed under such section 351, cleared under such section 510(k), or approved under such section 515 or 520(m);

(bb)

the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 505, 351, 510(k), 515, or 520(m); or

(cc)

except as provided in subclause (III), the application or premarket notification under such section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days.

(II)

Requirement that each clinical trial in application be treated the same

If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under section 351 of this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as applicable) of the use studied in the clinical trial.

(III)

Two-year limitation

The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.

(vi)

Extensions

The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial.

(F)

Notice to director of NIH

The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action.

(G)

Posting of data

The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission.

(H)

Waivers regarding certain clinical trial results

The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.

(I)

Adverse events

(i)

Regulations

Not later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for drugs described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists.

(ii)

Default

If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, clause (iii) shall take effect.

(iii)

Additional elements

Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for drugs described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:

(I)

Serious adverse events

A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

(II)

Frequent adverse events

A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.

(iv)

Posting of other information

In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.

(v)

Relation to subparagraph (c)

Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).

(4)

Additional submissions of clinical trial information

(A)

Voluntary submissions

A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act in an application or report for licensure, approval, or clearance of the drug or device for the use studied in the clinical trial.

(B)

Required submissions

(i)

In general

Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health—

(I)

the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission;

(II)

unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and

(III)

failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs.

(ii)

Clinical trials described

A clinical trial described in this clause is—

(I)

an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on or after the date 10 years before the date of the enactment of the Food and Drug Administration Amendments Act of 2007; or

(II)

an applicable clinical trial that is described by both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)).

(C)

Updates to clinical trial data bank

(i)

Submission of updates

The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates—

(I)

shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;

(II)

shall include identification of the dates of any such changes;

(III)

not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and

(IV)

not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.

(ii)

Public availability of updates

The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).

(5)

Coordination and compliance

(A)

Clinical trials supported by grants from Federal agencies

(i)

Grants from certain Federal agencies

If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).

(ii)

Verification by Federal agencies

The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee.

(iii)

Notice and opportunity to remedy

If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.

(iv)

Consultation with other Federal agencies

The Secretary shall—

(I)

consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and

(II)

develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3).

(B)

Certification to accompany drug, biological product, and device submissions

At the time of submission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, section 520(m) of such Act, or section 351 of this Act, or submission of a report under section 510(k) of such Act, such application or submission shall be accompanied by a certification that all applicable requirements of this subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial control numbers.

(C)

Quality control

(i)

Pilot quality control project

Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C).

(ii)

Notice of compliance

If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification.

(D)

Truthful clinical trial information

(i)

In general

The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.

(ii)

Effect

Clause (i) shall not have the effect of—

(I)

requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or

(II)

requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).

(E)

Public notices

(i)

Notice of violations

If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—

(I)

that the responsible party is not in compliance with this Act by—

(aa)

failing to submit required clinical trial information; or

(bb)

submitting false or misleading clinical trial information;

(II)

of the penalties imposed for the violation, if any; and

(III)

whether the responsible party has corrected the clinical trial information in the registry and results data bank.

(ii)

Notice of failure to submit primary and secondary outcomes

If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this act, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial.

(iii)

Failure to submit statement

The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry..

(iv)

Submission of false information statement

The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law..

(v)

Non-submission of statement

The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry..

(vi)

Compliance searches

The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph.

(6)

Limitation on disclosure of clinical trial information

(A)

In general

Nothing in this subsection (or under section 552 of title 5, United States Code) shall require the Secretary to publicly disclose, by any means other than the registry and results data bank, information described in subparagraph (B).

(B)

Information described

Information described in this subparagraph is—

(i)

information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and

(ii)

information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5, United States Code.

(7)

Authorization of appropriations

There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.

.

(b)

Conforming amendments

(1)

Prohibited acts

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(jj)
(1)

The failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service Act, or knowingly submitting a false certification under such section.

(2)

The failure to submit clinical trial information required under subsection (j) of section 402 of the Public Health Service Act.

(3)

The submission of clinical trial information under subsection (j) of section 402 of the Public Health Service Act that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).

.

(2)

Civil money penalties

Subsection (f) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as redesignated by section 226, is amended—

(A)

by redesignating paragraphs (3), (4), and (5) as paragraphs (5), (6), and (7), respectively;

(B)

by inserting after paragraph (2) the following:

(3)
(A)

Any person who violates section 301(jj) shall be subject to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding.

(B)

If a violation of section 301(jj) is not corrected within the 30-day period following notification under section 402(j)(5)(C)(ii), the person shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected.

;

(C)

in paragraph (2)(C), by striking paragraph (3)(A) and inserting paragraph (5)(A);

(D)

in paragraph (5), as so redesignated, by striking paragraph (1) or (2) each place it appears and inserting paragraph (1), (2), or (3);

(E)

in paragraph (6), as so redesignated, by striking paragraph (3)(A) and inserting paragraph (5)(A); and

(F)

in paragraph (7), as so redesignated, by striking paragraph (4) each place it appears and inserting paragraph (6).

(3)

New drugs and devices

(A)

Investigational new drugs

Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended in paragraph (4), by adding at the end the following: The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act..

(B)

New drug applications

Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following:

(6)

An application submitted under this subsection shall be accompanied by the certification required under section 402(j)(5)(B) of the Public Health Service Act. Such certification shall not be considered an element of such application.

.

(C)

Device reports under section 510(k)

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is amended by adding at the end the following:

A notification submitted under this subsection that contains clinical trial data for an applicable device clinical trial (as defined in section 402(j)(1) of the Public Health Service Act) shall be accompanied by the certification required under section 402(j)(5)(B) of such Act. Such certification shall not be considered an element of such notification.

.

(D)

Device premarket approval application

Section 515(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(1)) is amended—

(i)

in subparagraph (F), by striking ; and and inserting a semicolon;

(ii)

by redesignating subparagraph (G) as subparagraph (H); and

(iii)

by inserting after subparagraph (F) the following:

(G)

the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be considered an element of such application); and

.

(E)

Humanitarian device exemption

Section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended in the first sentence in the matter following subparagraph (C), by inserting at the end before the period and such application shall include the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be considered an element of such application).

(c)

Surveillances

Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act, as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial.

(d)

Preemption

(1)

In general

Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act, as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database.

(2)

Rule of construction

The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

IX

Enhanced Authorities Regarding Postmarket Safety of Drugs

A

Postmarket studies and surveillance

901.

Postmarket studies and clinical trials regarding human drugs; risk evaluation and mitigation strategies

(a)

In general

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following subsections:

(o)

Postmarket studies and clinical trials; labeling

(1)

In general

A responsible person may not introduce or deliver for introduction into interstate commerce the new drug involved if the person is in violation of a requirement established under paragraph (3) or (4) with respect to the drug.

(2)

Definitions

For purposes of this subsection:

(A)

Responsible person

The term responsible person means a person who—

(i)

has submitted to the Secretary a covered application that is pending; or

(ii)

is the holder of an approved covered application.

(B)

Covered application

The term covered application means—

(i)

an application under subsection (b) for a drug that is subject to section 503(b); and

(ii)

an application under section 351 of the Public Health Service Act.

(C)

New safety information; serious risk

The terms new safety information, serious risk, and signal of a serious risk have the meanings given such terms in section 505–1(b).

(3)

Studies and clinical trials

(A)

In general

For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to subparagraph (D), require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs.

(B)

Purposes of study or clinical trial

The purposes referred to in this subparagraph with respect to a postapproval study or postapproval clinical trial are the following:

(i)

To assess a known serious risk related to the use of the drug involved.

(ii)

To assess signals of serious risk related to the use of the drug.

(iii)

To identify an unexpected serious risk when available data indicates the potential for a serious risk.

(C)

Establishment of requirement after approval of covered application

The Secretary may require a postapproval study or studies or postapproval clinical trial or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary seeks to establish such requirement only if the Secretary becomes aware of new safety information.

(D)

Determination by Secretary

(i)

Postapproval studies

The Secretary may not require the responsible person to conduct a study under this paragraph, unless the Secretary makes a determination that the reports under subsection (k)(1) and the active postmarket risk identification and analysis system as available under subsection (k)(3) will not be sufficient to meet the purposes set forth in subparagraph (B).

(ii)

Postapproval clinical trials

The Secretary may not require the responsible person to conduct a clinical trial under this paragraph, unless the Secretary makes a determination that a postapproval study or studies will not be sufficient to meet the purposes set forth in subparagraph (B).

(E)

Notification; timetables; periodic reports

(i)

Notification

The Secretary shall notify the responsible person regarding a requirement under this paragraph to conduct a postapproval study or clinical trial by the target dates for communication of feedback from the review team to the responsible person regarding proposed labeling and postmarketing study commitments as set forth in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(ii)

Timetable; periodic reports

For each study or clinical trial required to be conducted under this paragraph, the Secretary shall require that the responsible person submit a timetable for completion of the study or clinical trial. With respect to each study required to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary shall require the responsible person to periodically report to the Secretary on the status of such study including whether any difficulties in completing the study have been encountered. With respect to each clinical trial required to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary shall require the responsible person to periodically report to the Secretary on the status of such clinical trial including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to the requirements under section 402(j) of the Public Health Service Act. If the responsible person fails to comply with such timetable or violates any other requirement of this subparagraph, the responsible person shall be considered in violation of this subsection, unless the responsible person demonstrates good cause for such noncompliance or such other violation. The Secretary shall determine what constitutes good cause under the preceding sentence.

(F)

Dispute resolution

The responsible person may appeal a requirement to conduct a study or clinical trial under this paragraph using dispute resolution procedures established by the Secretary in regulation and guidance.

(4)

Safety Labeling Changes Requested by Secretary

(A)

New safety information

If the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person or, if the same drug approved under section 505(b) is not currently marketed, the holder of an approved application under 505(j).

(B)

Response to notification

Following notification pursuant to subparagraph (A), the responsible person or the holder of the approved application under section 505(j) shall within 30 days—

(i)

submit a supplement proposing changes to the approved labeling to reflect the new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions; or

(ii)

notify the Secretary that the responsible person or the holder of the approved application under section 505(j) does not believe a labeling change is warranted and submit a statement detailing the reasons why such a change is not warranted.

(C)

Review

Upon receipt of such supplement, the Secretary shall promptly review and act upon such supplement. If the Secretary disagrees with the proposed changes in the supplement or with the statement setting forth the reasons why no labeling change is necessary, the Secretary shall initiate discussions to reach agreement on whether the labeling for the drug should be modified to reflect the new safety information, and if so, the contents of such labeling changes.

(D)

Discussions

Such discussions shall not extend for more than 30 days after the response to the notification under subparagraph (B), unless the Secretary determines an extension of such discussion period is warranted.

(E)

Order

Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary may issue an order directing the responsible person or the holder of the approved application under section 505(j) to make such a labeling change as the Secretary deems appropriate to address the new safety information. Within 15 days of such an order, the responsible person or the holder of the approved application under section 505(j) shall submit a supplement containing the labeling change.

(F)

Dispute Resolution

Within 5 days of receiving an order under subparagraph (E), the responsible person or the holder of the approved application under section 505(j) may appeal using dispute resolution procedures established by the Secretary in regulation and guidance.

(G)

Violation

If the responsible person or the holder of the approved application under section 505(j) has not submitted a supplement within 15 days of the date of such order under subparagraph (E), and there is no appeal or dispute resolution proceeding pending, the responsible person or holder shall be considered to be in violation of this subsection. If at the conclusion of any dispute resolution procedures the Secretary determines that a supplement must be submitted and such a supplement is not submitted within 15 days of the date of that determination, the responsible person or holder shall be in violation of this subsection.

(H)

Public health threat

Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that such a labeling change is necessary to protect the public health, the Secretary may accelerate the timelines in such subparagraphs.

(I)

Rule of construction

This paragraph shall not be construed to affect the responsibility of the responsible person or the holder of the approved application under section 505(j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).

(5)

Non-delegation

Determinations by the Secretary under this subsection for a drug shall be made by individuals at or above the level of individuals empowered to approve a drug (such as division directors within the Center for Drug Evaluation and Research).

(p)

Risk evaluation and mitigation strategy

(1)

In general

A person may not introduce or deliver for introduction into interstate commerce a new drug if—

(A)
(i)

the application for such drug is approved under subsection (b) or (j) and is subject to section 503(b); or

(ii)

the application for such drug is approved under section 351 of the Public Health Service Act; and

(B)

a risk evaluation and mitigation strategy is required under section 505–1 with respect to the drug and the person fails to maintain compliance with the requirements of the approved strategy or with other requirements under section 505–1, including requirements regarding assessments of approved strategies.

(2)

Certain postmarket studies

The failure to conduct a postmarket study under section 506, subpart H of part 314, or subpart E of part 601 of title 21, Code of Federal Regulations (or any successor regulations), is deemed to be a violation of paragraph (1).

.

(b)

Requirements regarding strategies

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following section:

505–1.

Risk evaluation and mitigation strategies

(a)

Submission of proposed strategy

(1)

Initial approval

If the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, determines that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug, and informs the person who submits such application of such determination, then such person shall submit to the Secretary as part of such application a proposed risk evaluation and mitigation strategy. In making such a determination, the Secretary shall consider the following factors:

(A)

The estimated size of the population likely to use the drug involved.

(B)

The seriousness of the disease or condition that is to be treated with the drug.

(C)

The expected benefit of the drug with respect to such disease or condition.

(D)

The expected or actual duration of treatment with the drug.

(E)

The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug.

(F)

Whether the drug is a new molecular entity.

(2)

Postapproval requirement

(A)

In general

If the Secretary has approved a covered application (including an application approved before the effective date of this section) and did not when approving the application require a risk evaluation and mitigation strategy under paragraph (1), the Secretary, in consultation with the offices described in paragraph (1), may subsequently require such a strategy for the drug involved (including when acting on a supplemental application seeking approval of a new indication for use of the drug) if the Secretary becomes aware of new safety information and makes a determination that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks of the drug.

(B)

Submission of proposed strategy

Not later than 120 days after the Secretary notifies the holder of an approved covered application that the Secretary has made a determination under subparagraph (A) with respect to the drug involved, or within such other reasonable time as the Secretary requires to protect the public health, the holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy.

(3)

Abbreviated new drug applications

The applicability of this section to an application under section 505(j) is subject to subsection (i).

(4)

Non-delegation

Determinations by the Secretary under this subsection for a drug shall be made by individuals at or above the level of individuals empowered to approve a drug (such as division directors within the Center for Drug Evaluation and Research).

(b)

Definitions

For purposes of this section:

(1)

Adverse drug experience

The term adverse drug experience means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including—

(A)

an adverse event occurring in the course of the use of the drug in professional practice;

(B)

an adverse event occurring from an overdose of the drug, whether accidental or intentional;

(C)

an adverse event occurring from abuse of the drug;

(D)

an adverse event occurring from withdrawal of the drug; and

(E)

any failure of expected pharmacological action of the drug.

(2)

Covered application

The term covered application means an application referred to in section 505(p)(1)(A).

(3)

New safety information

The term new safety information, with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study (including a study under section 505(o)(3)), or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system under section 505(k); or other scientific data deemed appropriate by the Secretary about—

(A)

a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing information) since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or

(B)

the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy.

(4)

Serious adverse drug experience

The term serious adverse drug experience is an adverse drug experience that—

(A)

results in—

(i)

death;

(ii)

an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form);

(iii)

inpatient hospitalization or prolongation of existing hospitalization;

(iv)

a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or

(v)

a congenital anomaly or birth defect; or

(B)

based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(5)

Serious risk

The term serious risk means a risk of a serious adverse drug experience.

(6)

Signal of a serious risk

The term signal of a serious risk means information related to a serious adverse drug experience associated with use of a drug and derived from—

(A)

a clinical trial;

(B)

adverse event reports;

(C)

a postapproval study, including a study under section 505(o)(3);

(D)

peer-reviewed biomedical literature;

(E)

data derived from the postmarket risk identification and analysis system under section 505(k)(4); or

(F)

other scientific data deemed appropriate by the Secretary.

(7)

Responsible person

The term responsible person means the person submitting a covered application or the holder of the approved such application.

(8)

Unexpected serious risk

The term unexpected serious risk means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.

(c)

Contents

A proposed risk evaluation and mitigation strategy under subsection (a) shall—

(1)

include the timetable required under subsection (d); and

(2)

to the extent required by the Secretary, in consultation with the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug, include additional elements described in subsections (e) and (f).

(d)

Minimal strategy

For purposes of subsection (c)(1), the risk evaluation and mitigation strategy for a drug shall require a timetable for submission of assessments of the strategy that—

(1)

includes an assessment, by the date that is 18 months after the strategy is initially approved;

(2)

includes an assessment by the date that is 3 years after the strategy is initially approved;

(3)

includes an assessment in the seventh year after the strategy is so approved; and

(4)

subject to paragraphs (1), (2), and (3)—

(A)

is at a frequency specified in the strategy;

(B)

is increased or reduced in frequency as necessary as provided for in subsection (g)(4)(A); and

(C)

is eliminated after the 3-year period described in paragraph (1) if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed.

(e)

Additional potential elements of strategy

(1)

In general

The Secretary, in consultation with the offices described in subsection (c)(2), may under such subsection require that the risk evaluation and mitigation strategy for a drug include 1 or more of the additional elements described in this subsection if the Secretary makes the determination required with respect to each element involved.

(2)

Medication Guide; patient package insert

The risk evaluation and mitigation strategy for a drug may require that, as applicable, the responsible person develop for distribution to each patient when the drug is dispensed—

(A)

a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); and

(B)

a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk of the drug.

(3)

Communication plan

The risk evaluation and mitigation strategy for a drug may require that the responsible person conduct a communication plan to health care providers, if, with respect to such drug, the Secretary determines that such plan may support implementation of an element of the strategy (including under this paragraph). Such plan may include—

(A)

sending letters to health care providers;

(B)

disseminating information about the elements of the risk evaluation and mitigation strategy to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or

(C)

disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to assure safe use.

(f)

Providing safe access for patients to drugs with known serious risks that would otherwise be unavailable

(1)

Allowing safe access to drugs with known serious risks

The Secretary, in consultation with the offices described in subsection (c)(2), may require that the risk evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that—

(A)

the drug, which has been shown to be effective, but is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug; and

(B)

for a drug initially approved without elements to assure safe use, other elements under subsections (c), (d), and (e) are not sufficient to mitigate such serious risk.

(2)

Assuring access and minimizing burden

Such elements to assure safe use under paragraph (1) shall—

(A)

be commensurate with the specific serious risk listed in the labeling of the drug;

(B)

within 30 days of the date on which any element under paragraph (1) is imposed, be posted publicly by the Secretary with an explanation of how such elements will mitigate the observed safety risk;

(C)

considering such risk, not be unduly burdensome on patient access to the drug, considering in particular—

(i)

patients with serious or life-threatening diseases or conditions; and

(ii)

patients who have difficulty accessing health care (such as patients in rural or medically underserved areas); and

(D)

to the extent practicable, so as to minimize the burden on the health care delivery system—

(i)

conform with elements to assure safe use for other drugs with similar, serious risks; and

(ii)

be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.

(3)

Elements to assure safe use

The elements to assure safe use under paragraph (1) shall include 1 or more goals to mitigate a specific serious risk listed in the labeling of the drug and, to mitigate such risk, may require that—

(A)

health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);

(B)

pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area);

(C)

the drug be dispensed to patients only in certain health care settings, such as hospitals;

(D)

the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;

(E)

each patient using the drug be subject to certain monitoring; or

(F)

each patient using the drug be enrolled in a registry.

(4)

Implementation system

The elements to assure safe use under paragraph (1) that are described in subparagraphs (B), (C), and (D) of paragraph (3) may include a system through which the applicant is able to take reasonable steps to—

(A)

monitor and evaluate implementation of such elements by health care providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements; and

(B)

work to improve implementation of such elements by such persons.

(5)

Evaluation of elements to assure safe use

The Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the Food and Drug Administration, shall—

(A)

seek input from patients, physicians, pharmacists, and other health care providers about how elements to assure safe use under this subsection for 1 or more drugs may be standardized so as not to be—

(i)

unduly burdensome on patient access to the drug; and

(ii)

to the extent practicable, minimize the burden on the health care delivery system;

(B)

at least annually, evaluate, for 1 or more drugs, the elements to assure safe use of such drug to assess whether the elements—

(i)

assure safe use of the drug;

(ii)

are not unduly burdensome on patient access to the drug; and

(iii)

to the extent practicable, minimize the burden on the health care delivery system; and

(C)

considering such input and evaluations—

(i)

issue or modify agency guidance about how to implement the requirements of this subsection; and

(ii)

modify elements under this subsection for 1 or more drugs as appropriate.

(6)

Additional mechanisms to assure access

The mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that is subject to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a physician may provide the drug under the mechanisms of section 561.

(7)

Waiver in public health emergencies

The Secretary may waive any requirement of this subsection during the period described in section 319(a) of the Public Health Service Act with respect to a qualified countermeasure described under section 319F–1(a)(2) of such Act, to which a requirement under this subsection has been applied, if the Secretary has—

(A)

declared a public health emergency under such section 319; and

(B)

determined that such waiver is required to mitigate the effects of, or reduce the severity of, such public health emergency.

(8)

Limitation

No holder of an approved covered application shall use any element to assure safe use required by the Secretary under this subsection to block or delay approval of an application under section 505(b)(2) or (j) or to prevent application of such element under subsection (i)(1)(B) to a drug that is the subject of an abbreviated new drug application.

(g)

Assessment and modification of approved strategy

(1)

Voluntary assessments

After the approval of a risk evaluation and mitigation strategy under subsection (a), the responsible person involved may, subject to paragraph (2), submit to the Secretary an assessment of, and propose a modification to, the approved strategy for the drug involved at any time.

(2)

Required assessments

A responsible person shall, subject to paragraph (5), submit an assessment of, and may propose a modification to, the approved risk evaluation and mitigation strategy for a drug—

(A)

when submitting a supplemental application for a new indication for use under section 505(b) or under section 351 of the Public Health Service Act, unless the drug is not subject to section 503(b) and the risk evaluation and mitigation strategy for the drug includes only the timetable under subsection (d);

(B)

when required by the strategy, as provided for in such timetable under subsection (d);

(C)

within a time period to be determined by the Secretary, if the Secretary, in consultation with the offices described in subsection (c)(2), determines that new safety or effectiveness information indicates that—

(i)

an element under subsection (d) or (e) should be modified or included in the strategy; or

(ii)

an element under subsection (f) should be modified or included in the strategy; or

(D)

within 15 days when ordered by the Secretary, in consultation with the offices described in subsection (c)(2), if the Secretary determines that there may be a cause for action by the Secretary under section 505(e).

(3)

Requirements for assessments

An assessment under paragraph (1) or (2) of an approved risk evaluation and mitigation strategy for a drug shall include—

(A)

with respect to any goal under subsection (f), an assessment of the extent to which the elements to assure safe use are meeting the goal or whether the goal or such elements should be modified;

(B)

with respect to any postapproval study required under section 505(o) or otherwise undertaken by the responsible person to investigate a safety issue, the status of such study, including whether any difficulties completing the study have been encountered; and

(C)

with respect to any postapproval clinical trial required under section 505(o) or otherwise undertaken by the responsible party to investigate a safety issue, the status of such clinical trial, including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to requirements under subsections (i) and (j) of section 402 of the Public Health Service Act.

(4)

Modification

A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subsection (d) or the addition, modification, or removal of any element under subsection (e) or (f), such as—

(A)

modifying the timetable for assessments of the strategy as provided in subsection (d)(3), including to eliminate assessments; or

(B)

adding, modifying, or removing an element to assure safe use under subsection (f).

(h)

Review of proposed strategies; review of assessments of approved strategies

(1)

In general

The Secretary, in consultation with the offices described in subsection (c)(2), shall promptly review each proposed risk evaluation and mitigation strategy for a drug submitted under subsection (a) and each assessment of an approved risk evaluation and mitigation strategy for a drug submitted under subsection (g).

(2)

Discussion

The Secretary, in consultation with the offices described in subsection (c)(2), shall initiate discussions with the responsible person for purposes of this subsection to determine a strategy not later than 60 days after any such assessment is submitted or, in the case of an assessment submitted under subsection (g)(2)(D), not later than 30 days after such assessment is submitted.

(3)

Action

(A)

In general

Unless the dispute resolution process described under paragraph (4) or (5) applies, the Secretary, in consultation with the offices described in subsection (c)(2), shall describe any required risk evaluation and mitigation strategy for a drug, or any modification to any required strategy—

(i)

as part of the action letter on the application, when a proposed strategy is submitted under subsection (a) or a modification to the strategy is proposed as part of an assessment of the strategy submitted under subsection (g)(1); or

(ii)

in an order issued not later than 90 days after the date discussions of such modification begin under paragraph (2), when a modification to the strategy is proposed as part of an assessment of the strategy submitted under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2).

(B)

Inaction

An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided under subparagraph (A).

(C)

Public availability

Any action letter described in subparagraph (A)(i) or order described in subparagraph (A)(ii) shall be made publicly available.

(4)

Dispute resolution at initial approval

If a proposed risk evaluation and mitigation strategy is submitted under subsection (a)(1) in an application for initial approval of a drug and there is a dispute about the strategy, the responsible person shall use the major dispute resolution procedures as set forth in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.

(5)

Dispute resolution in all other cases

(A)

Request for review

(i)

In general

Not earlier than 15 days, and not later than 35 days, after discussions under paragraph (2) have begun, the responsible person may request in writing that a dispute about the strategy be reviewed by the Drug Safety Oversight Board under subsection (j), except that the determination of the Secretary to require a risk evaluation and mitigation strategy is not subject to review under this paragraph. The preceding sentence does not prohibit review under this paragraph of the particular elements of such a strategy.

(ii)

Scheduling

Upon receipt of a request under clause (i), the Secretary shall schedule the dispute involved for review under subparagraph (B) and, not later than 5 business days of scheduling the dispute for review, shall publish by posting on the Internet or otherwise a notice that the dispute will be reviewed by the Drug Safety Oversight Board.

(B)

Scheduling review

If a responsible person requests review under subparagraph (A), the Secretary—

(i)

shall schedule the dispute for review at 1 of the next 2 regular meetings of the Drug Safety Oversight Board, whichever meeting date is more practicable; or

(ii)

may convene a special meeting of the Drug Safety Oversight Board to review the matter more promptly, including to meet an action deadline on an application (including a supplemental application).

(C)

Agreement after discussion or administrative appeals

(i)

Further discussion or administrative appeals

A request for review under subparagraph (A) shall not preclude further discussions to reach agreement on the risk evaluation and mitigation strategy, and such a request shall not preclude the use of administrative appeals within the Food and Drug Administration to reach agreement on the strategy, including appeals as described in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 for procedural or scientific matters involving the review of human drug applications and supplemental applications that cannot be resolved at the divisional level. At the time a review has been scheduled under subparagraph (B) and notice of such review has been posted, the responsible person shall either withdraw the request under subparagraph (A) or terminate the use of such administrative appeals.

(ii)

Agreement terminates dispute resolution

At any time before a decision and order is issued under subparagraph (G) , the Secretary (in consultation with the offices described in subsection (c)(2)) and the responsible person may reach an agreement on the risk evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the strategy.

(D)

Meeting of the board

At a meeting of the Drug Safety Oversight Board described in subparagraph (B), the Board shall—

(i)

hear from both parties via written or oral presentation; and

(ii)

review the dispute.

(E)

Record of proceedings

The Secretary shall ensure that the proceedings of any such meeting are recorded, transcribed, and made public within 90 days of the meeting. The Secretary shall redact the transcript to protect any trade secrets and other information that is exempted from disclosure under section 552 of title 5, United States Code, or section 552a of title 5, United States Code.

(F)

Recommendation of the Board

Not later than 5 days after any such meeting, the Drug Safety Oversight Board shall provide a written recommendation on resolving the dispute to the Secretary. Not later than 5 days after the Board provides such written recommendation to the Secretary, the Secretary shall make the recommendation available to the public.

(G)

Action by the Secretary

(i)

Action letter

With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall issue an action letter that resolves the dispute not later than the later of—

(I)

the action deadline for the action letter on the application; or

(II)

7 days after receiving the recommendation of the Drug Safety Oversight Board.

(ii)

Order

With respect to an assessment of an approved risk evaluation and mitigation strategy under subsection (g)(1) or under any of subparagraphs (B) through (D) of subsection (g)(2), the Secretary shall issue an order, which shall be made public, that resolves the dispute not later than 7 days after receiving the recommendation of the Drug Safety Oversight Board.

(H)

Inaction

An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided for under subparagraph (G).

(I)

Effect on action deadline

With respect to a proposal or assessment referred to in paragraph (1), the Secretary shall be considered to have met the action deadline for the action letter on the application if the responsible person requests the dispute resolution process described in this paragraph and if the Secretary—

(i)

has initiated the discussions described under paragraph (2) not less than 60 days before such action deadline; and

(ii)

has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under subparagraphs (B), (F), and (G), respectively.

(J)

Disqualification

No individual who is an employee of the Food and Drug Administration and who reviews a drug or who participated in an administrative appeal under subparagraph (C)(i) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under subparagraph (D) to review a dispute about the risk evaluation and mitigation strategy for such drug.

(K)

Additional expertise

The Drug Safety Oversight Board may add members with relevant expertise from the Food and Drug Administration, including the Office of Pediatrics, the Office of Women's Health, or the Office of Rare Diseases, or from other Federal public health or health care agencies, for a meeting under subparagraph (D) of the Drug Safety Oversight Board.

(6)

Use of advisory committees

The Secretary may convene a meeting of 1 or more advisory committees of the Food and Drug Administration to—

(A)

review a concern about the safety of a drug or class of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be submitted under any of subparagraphs (B) through (D) of subsection (g)(2);

(B)

review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; or

(C)

review a dispute under paragraph (4) or (5).

(7)

Process for addressing drug class effects

(A)

In general

When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary, in consultation with the offices described in subsection (c)(2), may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened 1 or more public meetings to consider possible responses to such concern.

(B)

Notice

If the Secretary defers an assessment under subparagraph (A), the Secretary shall—

(i)

give notice of the deferral to the holder of the approved covered application not later than 5 days after the deferral;

(ii)

publish the deferral in the Federal Register; and

(iii)

give notice to the public of any public meetings to be convened under subparagraph (A), including a description of the deferral.

(C)

Public meetings

Such public meetings may include—

(i)

1 or more meetings of the responsible person for such drugs;

(ii)

1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as provided for under paragraph (6); or

(iii)

1 or more workshops of scientific experts and other stakeholders.

(D)

Action

After considering the discussions from any meetings under subparagraph (A), the Secretary may—

(i)

announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological class;

(ii)

seek public comment about such action; and

(iii)

after seeking such comment, issue an order addressing such regulatory action.

(8)

International coordination

The Secretary, in consultation with the offices described in subsection (c)(2), may coordinate the timetable for submission of assessments under subsection (d), or a study or clinical trial under section 505(o)(3), with efforts to identify and assess the serious risks of such drug by the marketing authorities of other countries whose drug approval and risk management processes the Secretary deems comparable to the drug approval and risk management processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary shall give notice to the responsible person.

(9)

Effect

Use of the processes described in paragraphs (7) and (8) shall not be the sole source of delay of action on an application or a supplement to an application for a drug.

(i)

Abbreviated new drug applications

(1)

In general

A drug that is the subject of an abbreviated new drug application under section 505(j) is subject to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) for the applicable listed drug:

(A)

A Medication Guide or patient package insert, if required under subsection (e) for the applicable listed drug.

(B)

Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the subject of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application, and permit the applicant to use a different, comparable aspect of the elements to assure safe use, if the Secretary determines that—

(i)

the burden of creating a single, shared system outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the abbreviated new drug application, and the holder of the reference drug product; or

(ii)

an aspect of the elements to assure safe use for the applicable listed drug is claimed by a patent that has not expired or is a method or process that, as a trade secret, is entitled to protection, and the applicant for the abbreviated new drug application certifies that it has sought a license for use of an aspect of the elements to assure safe use for the applicable listed drug and that it was unable to obtain a license.

A certification under clause (ii) shall include a description of the efforts made by the applicant for the abbreviated new drug application to obtain a license. In a case described in clause (ii), the Secretary may seek to negotiate a voluntary agreement with the owner of the patent, method, or process for a license under which the applicant for such abbreviated new drug application may use an aspect of the elements to assure safe use, if required under subsection (f) for the applicable listed drug, that is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection.
(2)

Action by Secretary

For an applicable listed drug for which a drug is approved under section 505(j), the Secretary—

(A)

shall undertake any communication plan to health care providers required under subsection (e)(3) for the applicable listed drug; and

(B)

shall inform the responsible person for the drug that is so approved if the risk evaluation and mitigation strategy for the applicable listed drug is modified.

(j)

Drug safety oversight board

(1)

In general

There is established a Drug Safety Oversight Board.

(2)

Composition; meetings

The Drug Safety Oversight Board shall—

(A)

be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an employee of the Federal Government;

(B)

include representatives from offices throughout the Food and Drug Administration, including the offices responsible for postapproval safety of drugs;

(C)

include at least 1 representative each from the National Institutes of Health and the Department of Health and Human Services (other than the Food and Drug Administration);

(D)

include such representatives as the Secretary shall designate from other appropriate agencies that wish to provide representatives; and

(E)

meet at least monthly to provide oversight and advice to the Secretary on the management of important drug safety issues.

.

(c)

Regulation of biological products

Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—

(1)

in subsection (a)(2), by adding at the end the following:

(D)

Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy

A person that submits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and Cosmetic Act.

; and

(2)

in subsection (j), by inserting , including the requirements under sections 505(o), 505(p), and 505–1 of such Act, after , and Cosmetic Act.

(d)

Advertisements of drugs

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 801(b), is amended—

(1)

in section 301 (21 U.S.C. 331), by adding at the end the following:

(kk)

The dissemination of a television advertisement without complying with section 503B.

; and

(2)

by inserting after section 503A the following:

503B.

Prereview of television advertisements

(a)

In general

The Secretary may require the submission of any television advertisement for a drug (including any script, story board, rough, or a completed video production of the television advertisement) to the Secretary for review under this section not later than 45 days before dissemination of the television advertisement.

(b)

Review

In conducting a review of a television advertisement under this section, the Secretary may make recommendations with respect to information included in the label of the drug—

(1)

on changes that are—

(A)

necessary to protect the consumer good and well-being; or

(B)

consistent with prescribing information for the product under review; and

(2)

if appropriate and if information exists, on statements for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities.

(c)

No authority to require changes

Except as provided by subsection (e), this section does not authorize the Secretary to make or direct changes in any material submitted pursuant to subsection (a).

(d)

Elderly populations, children, racially and ethnically diverse communities

In formulating recommendations under subsection (b), the Secretary shall take into consideration the impact of the advertised drug on elderly populations, children, and racially and ethnically diverse communities.

(e)

Specific Disclosures

(1)

Serious risk; safety protocol

In conducting a review of a television advertisement under this section, if the Secretary determines that the advertisement would be false or misleading without a specific disclosure about a serious risk listed in the labeling of the drug involved, the Secretary may require inclusion of such disclosure in the advertisement.

(2)

Date of approval

In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed 2 years from the date of the approval of the drug under section 505 or section 351 of the Public Health Service Act, a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.

(f)

Rule of construction

Nothing in this section may be construed as having any effect on requirements under section 502(n) or on the authority of the Secretary under section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).

.

(3)

Direct-to-consumer advertisements

(A)

In general

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding at the end the following: In the case of an advertisement for a drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner..

(B)

Regulations to determine clear, conspicuous, and neutral manner

Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary of Health and Human Services shall by regulation establish standards for determining whether a major statement relating to side effects and contraindications of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) is presented in the manner required under such section.

(4)

Civil penalties

Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 801(b), is amended by adding at the end the following:

(g)
(1)

With respect to a person who is a holder of an approved application under section 505 for a drug subject to section 503(b) or under section 351 of the Public Health Service Act, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this Act (including the civil penalty in section 303(f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.

(2)

A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the person to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and section 554 of title 5, United States Code. If upon receipt of the written notice, the person to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in paragraph (3).

(3)

The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors:

(A)

Whether the person submitted the advertisement or a similar advertisement for review under section 736A.

(B)

Whether the person submitted the advertisement for review if required under section 503B.

(C)

Whether, after submission of the advertisement as described in subparagraph (A) or (B), the person disseminated or caused another party to disseminate the advertisement before the end of the 45-day comment period.

(D)

Whether the person incorporated any comments made by the Secretary with regard to the advertisement into the advertisement prior to its dissemination.

(E)

Whether the person ceased distribution of the advertisement upon receipt of the written notice referred to in paragraph (2) for such advertisement.

(F)

Whether the person had the advertisement reviewed by qualified medical, regulatory, and legal reviewers prior to its dissemination.

(G)

Whether the violations were material.

(H)

Whether the person who created the advertisement or caused the advertisement to be created acted in good faith.

(I)

Whether the person who created the advertisement or caused the advertisement to be created has been assessed a civil penalty under this provision within the previous 1-year period.

(J)

The scope and extent of any voluntary, subsequent remedial action by the person.

(K)

Such other matters, as justice may require.

(4)
(A)

Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the person submitted the advertisement to the Secretary and disseminated or caused another party to disseminate such advertisement after incorporating each comment received from the Secretary.

(B)

The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed circumstances, so long as the Secretary provides written notice to the person of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1).

(5)

The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owed by the United States to the person charged.

(6)

Any person who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued.

(7)

If any person fails to pay an assessment of a civil penalty under paragraph (1)—

(A)

after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or

(B)

after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary,

the Attorney General of the United States shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review.

.

(5)

Report on direct-to-consumer advertising

Not later than 24 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall report to the Congress on direct-to-consumer advertising and its ability to communicate to subsets of the general population, including elderly populations, children, and racial and ethnic minority communities. The Secretary shall utilize the Advisory Committee on Risk Communication established under this Act to advise the Secretary with respect to such report. The Advisory Committee shall study direct-to-consumer advertising as it relates to increased access to health information and decreased health disparities for these populations. The report required by this paragraph shall recommend effective ways to present and disseminate information to these populations. Such report shall also make recommendations regarding impediments to the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials and shall recommend best practice approaches for increasing the inclusion of such subsets of the general population. The Secretary of Health and Human Services shall submit the report under this paragraph to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(6)

Rulemaking

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking the procedure specified in section 701(e) of this Act and inserting section 701(a).

(e)

Rule of construction regarding pediatric studies

This title and the amendments made by this title may not be construed as affecting the authority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act or to require such studies under section 505B of such Act.

902.

Enforcement

(a)

Misbranding

Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

(y)

If it is a drug subject to an approved risk evaluation and mitigation strategy pursuant to section 505(p) and the responsible person (as such term is used in section 505–1) fails to comply with a requirement of such strategy provided for under subsection (d), (e), or (f) of section 505–1.

(z)

If it is a drug, and the responsible person (as such term is used in section 505(o)) is in violation of a requirement established under paragraph (3) (relating to postmarket studies and clinical trials) or paragraph (4) (relating to labeling) of section 505(o) with respect to such drug.

.

(b)

Civil penalties

Section 303(f) of the Federal Food, Drug, and Cosmetic Act, as amended by section 801(b), is amended—

(1)

by inserting after paragraph (3), as added by section 801(b)(2), the following:

(4)
(A)

Any responsible person (as such term is used in section 505–1) that violates a requirement of section 505(o), 505(p), or 505–1 shall be subject to a civil monetary penalty of—

(i)

not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or

(ii)

in the case of a violation that continues after the Secretary provides written notice to the responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any portion thereof) that the responsible person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding.

(B)

In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary shall take into consideration whether the responsible person is making efforts toward correcting the violation of the requirement of section 505(o), 505(p), or 505–1 for which the responsible person is subject to such civil penalty.

; and

(2)

in paragraph (5), as redesignated by section 801(b)(2)(A), by striking paragraph (1), (2), or (3) each place it appears and inserting paragraph (1), (2), (3), or (4).

903.

No effect on withdrawal or suspension of approval

Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the following: The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 505–1(g)(2)(D)..

904.

Benefit-risk assessments

Not later than 1 year after the date of the enactment of this Act, the Commissioner of Food and Drugs shall submit to the Congress a report on how best to communicate to the public the risks and benefits of new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits. As part of such study, the Commissioner may consider the possibility of including in the labeling and any direct-to-consumer advertisements of a newly approved drug or indication a unique symbol indicating the newly approved status of the drug or indication for a period after approval.

905.

Active postmarket risk identification and analysis

(a)

In general

Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

(3)

Active postmarket risk identification

(A)

Definition

In this paragraph, the term data refers to information with respect to a drug approved under this section or under section 351 of the Public Health Service Act, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any other data deemed appropriate by the Secretary.

(B)

Development of postmarket risk identification and analysis methods

The Secretary shall, not later than 2 years after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, in collaboration with public, academic, and private entities—

(i)

develop methods to obtain access to disparate data sources including the data sources specified in subparagraph (C);

(ii)

develop validated methods for the establishment of a postmarket risk identification and analysis system to link and analyze safety data from multiple sources, with the goals of including, in aggregate—

(I)

at least 25,000,000 patients by July 1, 2010; and

(II)

at least 100,000,000 patients by July 1, 2012; and

(iii)

convene a committee of experts, including individuals who are recognized in the field of protecting data privacy and security, to make recommendations to the Secretary on the development of tools and methods for the ethical and scientific uses for, and communication of, postmarketing data specified under subparagraph (C), including recommendations on the development of effective research methods for the study of drug safety questions.

(C)

Establishment of the postmarket risk identification and analysis system

(i)

In general

The Secretary shall, not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), establish and maintain procedures—

(I)

for risk identification and analysis based on electronic health data, in compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and in a manner that does not disclose individually identifiable health information in violation of paragraph (4)(B);

(II)

for the reporting (in a standardized form) of data on all serious adverse drug experiences (as defined in section 505–1(b)) submitted to the Secretary under paragraph (1), and those adverse events submitted by patients, providers, and drug sponsors, when appropriate;

(III)

to provide for active adverse event surveillance using the following data sources, as available:

(aa)

Federal health-related electronic data (such as data from the Medicare program and the health systems of the Department of Veterans Affairs);

(bb)

private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and

(cc)

other data as the Secretary deems necessary to create a robust system to identify adverse events and potential drug safety signals;

(IV)

to identify certain trends and patterns with respect to data accessed by the system;

(V)

to provide regular reports to the Secretary concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative national adverse event trends; and

(VI)

to enable the program to export data in a form appropriate for further aggregation, statistical analysis, and reporting.

(ii)

Timeliness of reporting

The procedures established under clause (i) shall ensure that such data are accessed, analyzed, and reported in a timely, routine, and systematic manner, taking into consideration the need for data completeness, coding, cleansing, and standardized analysis and transmission.

(iii)

Private sector resources

To ensure the establishment of the active postmarket risk identification and analysis system under this subsection not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), as required under clause (i), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities.

(iv)

Complementary approaches

To the extent the active postmarket risk identification and analysis system under this subsection is not sufficient to gather data and information relevant to a priority drug safety question, the Secretary shall develop, support, and participate in complementary approaches to gather and analyze such data and information, including—

(I)

approaches that are complementary with respect to assessing the safety of use of a drug in domestic populations not included, or underrepresented, in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children); and

(II)

existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or successor databases.

(v)

Authority for contracts

The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subparagraph.

(4)

Advanced analysis of drug safety data

(A)

Purpose

The Secretary shall establish collaborations with public, academic, and private entities, which may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other information that is publicly available or is provided by the Secretary, in order to—

(i)

improve the quality and efficiency of postmarket drug safety risk-benefit analysis;

(ii)

provide the Secretary with routine access to outside expertise to study advanced drug safety questions; and

(iii)

enhance the ability of the Secretary to make timely assessments based on drug safety data.

(B)

Privacy

Such analysis shall not disclose individually identifiable health information when presenting such drug safety signals and trends or when responding to inquiries regarding such drug safety signals and trends.

(C)

Public process for priority questions

At least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Committee (or any successor committee) and from other advisory committees, as appropriate, to the Food and Drug Administration on—

(i)

priority drug safety questions; and

(ii)

mechanisms for answering such questions, including through—

(I)

active risk identification under paragraph (3); and

(II)

when such risk identification is not sufficient, postapproval studies and clinical trials under subsection (o)(3).

(D)

Procedures for the development of drug safety collaborations

(i)

In general

Not later than 180 days after the date of the establishment of the active postmarket risk identification and analysis system under this subsection, the Secretary shall establish and implement procedures under which the Secretary may routinely contract with one or more qualified entities to—

(I)

classify, analyze, or aggregate data described in paragraph (3)(C) and information that is publicly available or is provided by the Secretary;

(II)

allow for prompt investigation of priority drug safety questions, including—

(aa)

unresolved safety questions for drugs or classes of drugs; and

(bb)

for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not included, or underrepresented, in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children);

(III)

perform advanced research and analysis on identified drug safety risks;

(IV)

focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a drug; and

(V)

carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph.

(ii)

Request for specific methodology

The procedures described in clause (i) shall permit the Secretary to request that a specific methodology be used by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be used.

(E)

Use of analyses

The Secretary shall provide the analyses described in this paragraph, including the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.

(F)

Qualified entities

(i)

In general

The Secretary shall enter into contracts with a sufficient number of qualified entities to develop and provide information to the Secretary in a timely manner.

(ii)

Qualification

The Secretary shall enter into a contract with an entity under clause (i) only if the Secretary determines that the entity has a significant presence in the United States and has one or more of the following qualifications:

(I)

The research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this paragraph, including the capability and expertise to provide the Secretary de-identified data consistent with the requirements of this subsection.

(II)

An information technology infrastructure in place to support electronic data and operational standards to provide security for such data.

(III)

Experience with, and expertise on, the development of drug safety and effectiveness research using electronic population data.

(IV)

An understanding of drug development or risk/benefit balancing in a clinical setting.

(V)

Other expertise which the Secretary deems necessary to fulfill the activities under this paragraph.

(G)

Contract requirements

Each contract with a qualified entity under subparagraph (F)(i) shall contain the following requirements:

(i)

Ensuring privacy

The qualified entity shall ensure that the entity will not use data under this subsection in a manner that—

(I)

violates the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996;

(II)

violates sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually-identifiable beneficiary health information; or

(III)

discloses individually identifiable health information when presenting drug safety signals and trends or when responding to inquiries regarding drug safety signals and trends.

Nothing in this clause prohibits lawful disclosure for other purposes.
(ii)

Component of another organization

If a qualified entity is a component of another organization—

(I)

the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and

(II)

the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirement.

(iii)

Termination or nonrenewal

If a contract with a qualified entity under this subparagraph is terminated or not renewed, the following requirements shall apply:

(I)

Confidentiality and privacy protections

The entity shall continue to comply with the confidentiality and privacy requirements under this paragraph with respect to all data disclosed to the entity.

(II)

Disposition of data

The entity shall return any data disclosed to such entity under this subsection to which it would not otherwise have access or, if returning the data is not practicable, destroy the data.

(H)

Competitive procedures

The Secretary shall use competitive procedures (as defined in section 4(5) of the Federal Procurement Policy Act) to enter into contracts under subparagraph (G).

(I)

Review of contract in the event of a merger or acquisition

The Secretary shall review the contract with a qualified entity under this paragraph in the event of a merger or acquisition of the entity in order to ensure that the requirements under this paragraph will continue to be met.

(J)

Coordination

In carrying out this paragraph, the Secretary shall provide for appropriate communications to the public, scientific, public health, and medical communities, and other key stakeholders, and to the extent practicable shall coordinate with the activities of private entities, professional associations, or other entities that may have sources of drug safety data.

.

(b)

Rule of construction

Nothing in this section or the amendment made by this section shall be construed to prohibit the lawful disclosure or use of data or information by an entity other than as described in paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(c)

Report to congress

Not later than 4 years after the date of the enactment of this Act, the Secretary shall report to the Congress on the ways in which the Secretary has used the active postmarket risk identification and analysis system described in paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), to identify specific drug safety signals and to better understand the outcomes associated with drugs marketed in the United States.

(d)

Authorization of appropriations

To carry out activities under the amendment made by this section for which funds are made available under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are authorized to be appropriated to carry out the amendment made by this section, in addition to such funds, $25,000,000 for each of fiscal years 2008 through 2012.

(e)

GAO report

Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall evaluate data privacy, confidentiality, and security issues relating to accessing, transmitting, and maintaining data for the active postmarket risk identification and analysis system described in paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and make recommendations to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate, and any other congressional committees of relevant jurisdiction, regarding the need for any additional legislative or regulatory actions to ensure privacy, confidentiality, and security of this data or otherwise address privacy, confidentiality, and security issues to ensure the effective operation of such active postmarket identification and analysis system.

906.

Statement for inclusion in direct-to-consumer advertisements of drugs

(a)

Published direct-to-consumer advertisements

Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by section 901(d)(6), is further amended by inserting and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088., after section 701(a),.

(b)

Study

(1)

In general

In the case of direct-to-consumer television advertisements, the Secretary of Health and Human Services, in consultation with the Advisory Committee on Risk Communication under section 567 of the Federal Food, Drug, and Cosmetic Act (as added by section 917), shall, not later than 6 months after the date of the enactment of this Act, conduct a study to determine if the statement in section 502(n) of such Act (as added by subsection (a)) required with respect to published direct-to-consumer advertisements is appropriate for inclusion in such television advertisements.

(2)

Content

As part of the study under paragraph (1), such Secretary shall consider whether the information in the statement described in paragraph (1) would detract from the presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion of such statement is appropriate in direct-to-consumer television advertisements, such Secretary shall issue regulations requiring the implementation of such statement in direct-to-consumer television advertisements, including determining a reasonable length of time for displaying the statement in such advertisements. The Secretary shall report to the appropriate committees of Congress the findings of such study and any plans to issue regulations under this paragraph.

907.

No effect on veterinary medicine

This subtitle, and the amendments made by this subtitle, shall have no effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act by, or on the lawful written or oral order of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such Act.

908.

Authorization of appropriations

(a)

In general

For carrying out this subtitle and the amendments made by this subtitle, there is authorized to be appropriated $25,000,000 for each of fiscal years 2008 through 2012.

(b)

Relation to other funding

The authorization of appropriations under subsection (a) is in addition to any other funds available for carrying out this subtitle and the amendments made by this subtitle.

909.

Effective date and applicability

(a)

Effective date

This subtitle takes effect 180 days after the date of the enactment of this Act.

(b)

Drugs deemed to have risk evaluation and mitigation strategies

(1)

In general

A drug that was approved before the effective date of this Act is, in accordance with paragraph (2), deemed to have in effect an approved risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act (as added by section 901) (referred to in this section as the Act) if there are in effect on the effective date of this Act elements to assure safe use—

(A)

required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or

(B)

otherwise agreed to by the applicant and the Secretary for such drug.

(2)

Elements of strategy; enforcement

The approved risk evaluation and mitigation strategy in effect for a drug under paragraph (1)—

(A)

is deemed to consist of the timetable required under section 505–1(d) and any additional elements under subsections (e) and (f) of such section in effect for such drug on the effective date of this Act; and

(B)

is subject to enforcement by the Secretary to the same extent as any other risk evaluation and mitigation strategy under section 505–1 of the Act, except that sections 303(f)(4) and 502(y) and (z) of the Act (as added by section 902) shall not apply to such strategy before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505–1.

(3)

Submission

Not later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitigation strategy is deemed to be in effect under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505–1 of the Act as if included in such application at the time of submission of the application to the Secretary.

B

Other provisions to ensure drug safety and surveillance

911.

Clinical trial guidance for antibiotic drugs

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:

511.

Clinical trial guidance for antibiotic drugs

(a)

In General

Not later than 1 year after the date of the enactment of this section, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.

(b)

Review

Not later than 5 years after the date of the enactment of this section, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.

.

912.

Prohibition against food to which drugs or biological products have been added

(a)

Prohibition

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 901(d), is amended by adding at the end the following:

(ll)

The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—

(1)

such drug or such biological product was marketed in food before any approval of the drug under section 505, before licensure of the biological product under such section 351, and before any substantial clinical investigations involving the drug or the biological product have been instituted;

(2)

the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food;

(3)

the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—

(A)

a regulation issued under section 409 prescribing conditions of safe use in food;

(B)

a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;

(C)

the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier's determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;

(D)

a food contact substance notification that is effective under section 409(h); or

(E)

such drug or biological product had been marketed for smoking cessation prior to the date of the enactment of the Food and Drug Administration Amendments Act of 2007; or

(4)

the drug is a new animal drug whose use is not unsafe under section 512.

.

(b)

Conforming changes

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

(1)

in section 304(a)(1), by striking section 404 or 505 and inserting section 301(ll), 404, or 505; and

(2)

in section 801(a), by striking is adulterated, misbranded, or in violation of section 505, and inserting is adulterated, misbranded, or in violation of section 505, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll),.

913.

Assuring pharmaceutical safety

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended in section 403, is amended by inserting after section 505C the following:

505D.

Pharmaceutical security

(a)

In general

The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.

(b)

Standards development

(1)

In general

The Secretary shall, in consultation with the agencies specified in paragraph (4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.

(2)

Standardized numeral identifier

Not later than 30 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.

(3)

Promising technologies

The standards developed under this subsection shall address promising technologies, which may include—

(A)

radio frequency identification technology;

(B)

nanotechnology;

(C)

encryption technologies; and

(D)

other track-and-trace or authentication technologies.

(4)

Interagency collaboration

In carrying out this subsection, the Secretary shall consult with Federal health and security agencies, including—

(A)

the Department of Justice;

(B)

the Department of Homeland Security;

(C)

the Department of Commerce; and

(D)

other appropriate Federal and State agencies.

(c)

Inspection and enforcement

(1)

In general

The Secretary shall expand and enhance the resources and facilities of agency components of the Food and Drug Administration involved with regulatory and criminal enforcement of this Act to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs including biological products and active pharmaceutical ingredients from domestic and foreign sources.

(2)

Activities

The Secretary shall undertake enhanced and joint enforcement activities with other Federal and State agencies, and establish regional capacities for the validation of prescription drugs and the inspection of the prescription drug supply chain.

(d)

Definition

In this section, the term prescription drug means a drug subject to section 503(b)(1).

.

914.

Citizen petitions and petitions for stay of agency action

(a)

In general

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 901(a), is amended by adding at the end the following:

(q)

Petitions and civil actions regarding approval of certain applications

(1)

In general

(A)

Determination

The Secretary shall not delay approval of a pending application submitted under subsection (b)(2) or (j) because of any request to take any form of action relating to the application, either before or during consideration of the request, unless—

(i)

the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30 or 10.35 of title 21, Code of Federal Regulations (or any successor regulations); and

(ii)

the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.

(B)

Notification

If the Secretary determines under subparagraph (A) that a delay is necessary with respect to an application, the Secretary shall provide to the applicant, not later than 30 days after making such determination, the following information:

(i)

Notification of the fact that a determination under subparagraph (A) has been made.

(ii)

If applicable, any clarification or additional data that the applicant should submit to the docket on the petition to allow the Secretary to review the petition promptly.

(iii)

A brief summary of the specific substantive issues raised in the petition which form the basis of the determination.

(C)

Format

The information described in subparagraph (B) shall be conveyed via either, at the discretion of the Secretary—

(i)

a document; or

(ii)

a meeting with the applicant involved.

(D)

Public disclosure

Any information conveyed by the Secretary under subparagraph (C) shall be considered part of the application and shall be subject to the disclosure requirements applicable to information in such application.

(E)

Denial based on intent to delay

If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination. The Secretary may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application.

(F)

Final agency action

The Secretary shall take final agency action on a petition not later than 180 days after the date on which the petition is submitted. The Secretary shall not extend such period for any reason, including—

(i)

any determination made under subparagraph (A);

(ii)

the submission of comments relating to the petition or supplemental information supplied by the petitioner; or

(iii)

the consent of the petitioner.

(G)

Extension of 30-month period

If the filing of an application resulted in first-applicant status under subsection (j)(5)(D)(i)(IV) and approval of the application was delayed because of a petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, the petition.

(H)

Certification

The Secretary shall not consider a petition for review unless the party submitting such petition does so in written form and the subject document is signed and contains the following certification: I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: __________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: _____________. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition., with the date on which such information first became known to such party and the names of such persons or organizations inserted in the first and second blank space, respectively.

(I)

Verification

The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and the subject document is signed and contains the following verification: I certify that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the action requested herein first became known to me on or about __________. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: _____. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition., with the date on which such information first became known to the party and the names of such persons or organizations inserted in the first and second blank space, respectively.

(2)

Exhaustion of administrative remedies

(A)

Final agency action within 180 days

The Secretary shall be considered to have taken final agency action on a petition if—

(i)

during the 180-day period referred to in paragraph (1)(F), the Secretary makes a final decision within the meaning of section 10.45(d) of title 21, Code of Federal Regulations (or any successor regulation); or

(ii)

such period expires without the Secretary having made such a final decision.

(B)

Dismissal of certain civil actions

If a civil action is filed against the Secretary with respect to any issue raised in the petition before the Secretary has taken final agency action on the petition within the meaning of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.

(C)

Administrative record

For purposes of judicial review related to the approval of an application for which a petition under paragraph (1) was submitted, the administrative record regarding any issue raised by the petition s