< Back to S. 3807 (109th Congress, 2005–2006)

Text of the Enhancing Drug Safety and Innovation Act of 2006

This bill was introduced on August 3, 2006, in a previous session of Congress, but was not enacted. The text of the bill below is as of Aug 3, 2006 (Introduced).

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II

109th CONGRESS

2d Session

S. 3807

IN THE SENATE OF THE UNITED STATES

August 3, 2006

(for himself and Mr. Kennedy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes.

1.

Short title

This Act may be cited as the Enhancing Drug Safety and Innovation Act of 2006.

I

Risk evaluation and mitigation strategies

101.

Risk evaluation and mitigation strategies

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

(o)

Risk evaluation and mitigation strategy

(1)

In general

In the case of any drug subject to subsection (b) or (j) or section 351 of the Public Health Service Act for which a risk evaluation and mitigation strategy is approved as provided for in this subsection, the applicant shall comply with the requirements of such strategy, which—

(A)

shall require the elements under paragraph (3); and

(B)

may require one or more additional elements under paragraph (4) or (5), so long as the Secretary makes the determination required with respect to each such element.

(2)

Definitions

In this subsection:

(A)

Serious risk

The term serious risk means a risk of a serious adverse drug experience as defined in section 314.80 of title 21, Code of Federal Regulations (or any successor regulation).

(B)

Unexpected serious risk

The term unexpected serious risk means a serious adverse drug experience as defined in section 314.80 of title 21, Code of Federal Regulations (or any successor regulation) 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 or specificity.

(C)

Empirical signal of a serious risk

The term empirical signal of a serious risk means information related to a serious adverse drug experience as defined in section 314.80 of title 21, Code of Federal Regulations (or any successor regulation) associated with use of a drug and derived from—

(i)

a clinical trial;

(ii)

adverse event reports;

(iii)

a post-approval study, including a study under paragraph (4)(D); or

(iv)

peer-reviewed biomedical literature.

(D)

New safety information

The term new safety information with respect to a drug means information about—

(i)

a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or

(ii)

the effectiveness of the approved risk evaluation and mitigation strategy for the drug.

(E)

Drug safety oversight board

The term Drug Safety Oversight Board means a body of scientists who have been appointed to serve from offices throughout the Food and Drug Administration and other Federal agencies to provide oversight and advice to the Secretary through the Director of the Center for Drug Evaluation and Research of the Food and Drug Administration on the management of important drug safety issues and which meets monthly.

(3)

Required elements of a risk evaluation and mitigation strategy

The risk evaluation and mitigation strategy for a drug shall require—

(A)

labeling for the drug for use by health care providers as approved under subsection (c);

(B)
(i)

submission of reports for the drug as required under subsection (k); and

(ii)

for a drug that is a vaccine—

(I)

analysis by the Secretary of reports to the Vaccine Adverse Event Reporting Systems (VAERS); or

(II)

surveillance by the Secretary using the Vaccine Safety Datalink (VSD) or successor databases;

(C)

a pharmacovigilance statement as to whether—

(i)

the reports under subparagraph (B)(i) or, for a vaccine, the analysis and surveillance under subparagraph (B)(ii), and the periodic assessment under subparagraph (E), are sufficient to assess the serious risks and to identify unexpected serious risks of the drug; or

(ii)

studies under paragraph (4)(D) or clinical trials under paragraph (4)(E) are needed to assess the serious risks and identify unexpected serious risks of the drug;

(D)

a justification for the pharmacovigilance statement in subparagraph (C) that takes into consideration—

(i)

the estimated size of the treatment population for the drug;

(ii)

the seriousness of the disease or condition that the drug is used to treat;

(iii)

the expected or actual duration of treatment with the drug;

(iv)

the availability and safety of a drug or other treatment, if any, for such disease or condition to which the drug may be compared; and

(v)

the seriousness of the risk at issue and its background incidence in the population; and

(E)

a timetable for submission of assessments of the strategy, that—

(i)

shall be no less frequently than once annually for the first 3 years after the drug is initially approved under subsection (c) or licensed under section 351 of the Public Health Service Act, and at a frequency determined by the Secretary for subsequent years;

(ii)

may be increased or reduced by the Secretary in frequency as necessary; and

(iii)

may be eliminated after the first 3 years if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed.

(4)

Additional potential elements of a risk evaluation and mitigation strategy

(A)

In general

The risk evaluation and mitigation strategy for a drug may require one or more of the additional elements described in this paragraph, so long as the Secretary makes the determination required with respect to each such element.

(B)

Medguide

The risk evaluation and mitigation strategy for a drug may require that the applicant develop for distribution to each patient when the drug is dispensed—

(i)

a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii)

a patient package insert, if the Secretary determines that such insert may help minimize a serious risk of the drug.

(C)

Communication plan

The risk evaluation and mitigation strategy for a drug may require that the applicant 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 under subparagraph (D) or (E) or under paragraph (5), which may include—

(i)

sending letters to health care providers;

(ii)

disseminating information about the elements of the risk evaluation and mitigation strategy to encourage compliance by health care providers with components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); or

(iii)

disseminating information to health care providers through professional societies about any serious risks of the drug and how to prescribe and use the drug safely.

(D)

Post-approval studies

The risk evaluation and mitigation strategy for a drug may require that the applicant or the Secretary conduct an appropriate post-approval study of the drug (with target commencement and completion dates), if the Secretary determines the study is necessary to assess an empirical signal of a serious risk with use of the drug or to identify unexpected serious risks in domestic populations who use the drug but were not included in studies used to approve the drug (such as older people, people with comorbidities, pregnant women, or children), such as a prospective or retrospective observational study.

(E)

Post-approval clinical trials

The risk evaluation and mitigation strategy for a drug may require that the applicant for a drug for which there is no effective approved application under subsection (j) as of the date that the requirement is first imposed conduct an appropriate post-approval clinical trial of the drug (with target commencement and completion dates), to be included in the clinical trial registry database and clinical trial results database provided for under section 402(j) of the Public Health Service Act, if the Secretary determines that the clinical trial is necessary, and that a study under subparagraph (D) will likely be inadequate, to assess an empirical signal of a serious risk with use of the drug;

(F)

Preclearance

The risk evaluation and mitigation strategy for a drug may require that the applicant submit to the Secretary advertisements of the drug for preclearance, if the Secretary determines that such preclearance is necessary to ensure compliance with section 502(n) with respect to the disclosure of information about a serious risk listed in the labeling of the drug, so long as advertisements required to be submitted under this subparagraph are reviewed and cleared within 30 days by the Secretary.

(G)

Specific disclosures

The risk evaluation and mitigation strategy for a drug may require that the applicant include a specific disclosure in advertisements of the drug, if the Secretary determines that advertisements lacking such disclosure would be false or misleading or that such disclosure is necessary to protect public health and safety—

(i)

of the date the drug was approved and that the existing information may not have identified or fully assessed all serious risks of using the drug;

(ii)

about a serious adverse event listed in the labeling of the drug; or

(iii)

about a protocol to ensure safe use described in the labeling of the drug; or

(H)

Temporary moratorium

The risk evaluation and mitigation strategy for a drug may require that for a fixed period after initial approval, not to exceed 2 years, the applicant not issue or cause to be issued direct-to-consumer advertisements of the drug, if the Secretary determines that disclosure under subparagraph (G) is inadequate to protect public health and safety, and that such prohibition is necessary to protect public health and safety while additional information about serious risks of the drug is collected, considering—

(i)

the number of patients who may be treated with the drug;

(ii)

the seriousness of the condition for which the drug will be used;

(iii)

the serious adverse events listed in the labeling of the drug;

(iv)

the extent to which patients have access to other approved drugs in the pharmacological class of the drug and with the same intended use as the drug; and

(v)

the extent to which studies used to approve the drug may not have identified serious risks that might occur among patients expected to be treated with the drug.

(5)

Restrictions on distribution and use

(A)

In general

If the Secretary determines that a drug presents a significant risk to public health, and provides significant benefits to patients, the risk evaluation and mitigation strategy may require restrictions on distribution and use to address such risk of the drug, so long as application of elements under paragraph (4) are insufficient to manage such risk.

(B)

Limits on restrictions

Such restrictions under subparagraph (A) shall be—

(i)

commensurate with the risk;

(ii)

necessary to ensure safe use of the drug given the risk; and

(iii)

not unduly burdensome on patient access to the drug, particularly for patients with serious or life-threatening diseases or conditions.

(C)

Elements

The restrictions on distribution and use described under subparagraph (A) shall include one or more goals to evaluate or mitigate a serious risk listed in the labeling of the drug and may require that—

(i)

health care providers that prescribe the drug have particular training or experience, or elect to be specially certified;

(ii)

pharmacies, practitioners, or health care settings that dispense the drug elect to be specially certified;

(iii)

the drug be dispensed to patients only in certain health care settings, such as hospitals;

(iv)

the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;

(v)

each patient using the drug be subject to certain monitoring; or

(vi)

each patient using the drug be enrolled in a registry.

(D)

Compliance System

The restrictions on distribution and use described under subparagraph (A) may require a compliance system through which the applicant is able to—

(i)

monitor and evaluate compliance with the restrictions by health care providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restrictions;

(ii)

work to improve implementation of the restrictions by health care providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restrictions; and

(iii)

limit participation by those health care providers, pharmacists, and other parties in the health care system—

(I)

who are responsible for implementing the restrictions; and

(II)

whom the applicant knows have failed to meet their responsibilities for implementing the restrictions, after the applicant has informed such party of such failure and such party has not remedied such failure.

(6)

Submission and review of risk evaluation and mitigation strategy

(A)

Proposed risk evaluation and mitigation strategy

An applicant shall include in an application under subsection (b) or section 351 of the Public Health Service Act (including in a supplemental application seeking a new indication if no risk evaluation and mitigation strategy for the drug is in effect under this subsection) a proposed risk evaluation and mitigation strategy, which—

(i)

shall include the minimal elements required under paragraph (3); and

(ii)

may also include additional elements as provided for under paragraphs (4) and (5).

(B)

Assessment and modification of a risk evaluation and mitigation strategy

(i)

In general

The applicant may submit to the Secretary an assessment of, and propose a modification to, the approved risk evaluation and mitigation strategy for a drug at any time, and shall submit such an assessment, which may propose such a modification—

(I)

when submitting a supplemental application for a new indication under subsection (b) or section 351 of the Public Health Service Act;

(II)

when required by the strategy, as provided for in the timetable under paragraph (3)(E);

(III)

within a time specified by the Secretary, not to be less than 45 days, when ordered by the Secretary if the Secretary determines that new safety information indicates that an element under paragraph (3) or (4) should be modified or included in the strategy;

(IV)

within 90 days when ordered by the Secretary if the Secretary determines that new safety information indicates that an element under paragraph (5) should be modified or included in the strategy; or

(V)

within 15 days when ordered by the Secretary if the Secretary determines that there may be a cause for action by the Secretary under subsection (e).

(ii)

Assessment

An assessment of the performance and adequacy of the approved risk evaluation and mitigation strategy for a drug shall include—

(I)

with respect to any goal under paragraph (5), an assessment of whether the restrictions on distribution and use are meeting the goal or whether the goal or such restrictions should be modified;

(II)

with respect to any post-approval study required under paragraph (4)(D), the status of such study, the expected completion date, and whether any difficulties completing the study have been encountered; and

(III)

with respect to any post-approval clinical trial required under paragraph (4)(E), whether enrollment has begun, the number of participants enrolled, the expected completion date, and whether any difficulties completing the clinical trial have been encountered.

(iii)

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 subparagraph (A), (C), or (D) of paragraph (3) or the addition, modification, or removal of any element under paragraph (4) or (5), such as—

(I)

a labeling change, including the addition of a boxed warning;

(II)

adding a post-approval study or clinical trial requirement;

(III)

modifying a post-approval study or clinical trial requirement (such as a change in trial design due to legitimate difficulties recruiting participants);

(IV)

adding, modifying, or removing a restriction on advertising under subparagraph (F), (G), or (H) of paragraph (4);

(V)

adding, modifying, or removing a restriction on distribution or use under paragraph (5); or

(VI)

modifying the timetable for assessments of the strategy under paragraph (3)(E).

(C)

Review

The Secretary shall promptly review the proposed risk evaluation and mitigation strategy for a drug submitted under paragraph (A), or an assessment of the approved risk evaluation and mitigation strategy for a drug submitted under subparagraph (B).

(D)

Discussion

The Secretary shall initiate discussions of the proposed risk evaluation and mitigation strategy for a drug submitted under subparagraph (A), or of an assessment of the approved risk evaluation and mitigation strategy for a drug submitted under subparagraph (B), with the applicant to determine a mutually agreeable strategy—

(i)

when submitted as part of an application or supplemental application under subparagraph (A) or (B)(i)(I), not less than 60 days before the action deadline for the application that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the review of human drug applications);

(ii)

when submitted under subparagraph (B)(i)(II) or (III), not later than 20 days after such submission;

(iii)

when submitted voluntarily by the applicant or under subparagraph (B)(i)(IV), not later than 30 days after such submission; or

(iv)

when submitted under subparagraph (B)(i)(V), not later than 10 days after such submission.

(E)

Action

(i)

In general

Unless the applicant requests the dispute resolution process described under subparagraph (F), the Secretary shall approve and describe the risk evaluation and mitigation strategy for a drug, or any modification to the strategy—

(I)

as part of the action letter on the application, when a proposed strategy is submitted under subparagraph (A) or an assessment of the strategy is submitted under subparagraph (B)(i)(I); or

(II)

in an order, which shall be made public, issued not later than 50 days after the date discussions of such modification begin under subparagraph (C), when an assessment of the strategy is submitted voluntarily by the applicant or under subclause (II), (III), (IV), or (V) of subparagraph (B)(i).

(ii)

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 clause (i).

(F)

Dispute resolution

(i)

Request for review

Not earlier than 15 days, and not later than 35 days, after discussions under subparagraph (D) have begun to determine a mutually agreeable risk evaluation and mitigation strategy, the applicant may request in writing that a dispute about the strategy be reviewed by the Drug Safety Oversight Board.

(ii)

Scheduling review

If the applicant requests review under clause (i), 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).

(iii)

Agreement terminates dispute resolution

At any time before a decision and order is issued under clause (vi), the Secretary and the applicant may reach an agreement on the risk evaluation and mitigation strategy, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the mutually agreeable strategy.

(iv)

Meeting of the board

At the meeting of the Drug Safety Oversight Board described in clause (ii), the Board shall—

(I)

hear from both parties; and

(II)

review the dispute.

(v)

Recommendation of the Board

Not later than 5 days after such meeting of the Drug Safety Oversight Board, the Board shall provide a written recommendation on resolving the dispute to the Secretary.

(vi)

Action by the secretary

(I)

Action letter

With respect to a proposed risk evaluation and mitigation strategy submitted under subparagraph (A) or to an assessment of the strategy submitted under subparagraph (B)(i)(I), the Secretary shall issue an action letter that resolves the dispute not later than the later of—

(aa)

the action deadline referred to in subparagraph (D)(i); or

(bb)

7 days after receiving the recommendation of the Drug Safety Oversight Board.

(II)

Order

With respect to an assessment of the risk evaluation and mitigation strategy submitted voluntarily by the applicant or under subclause (II), (III), (IV), or (V) of subparagraph (B)(i), 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.

(vii)

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 clause (vi).

(viii)

Effect on action deadline

With respect to the application or supplemental application in which a proposed risk evaluation and mitigation strategy is submitted under subparagraph (A) or in which an assessment of the strategy is submitted under subparagraph (B)(i)(I), the Secretary shall be considered to have met the action deadline referred to in subparagraph (D)(i) with respect to such application if the applicant requests the dispute resolution process described in this subparagraph and if the Secretary—

(I)

has initiated the discussions described under such subparagraph not less than 60 days before such action deadline; and

(II)

has complied with the timing requirements of scheduling review, providing a written recommendation, and issuing an action letter under clauses (ii), (v), and (vi), respectively.

(ix)

Other dispute resolution

Procedural or scientific matters involving the review of human drug applications and supplements that cannot be resolved at the divisional level may in addition be appealed as described in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the review of human drug applications).

(x)

Disqualification

No individual who is an employee of the Food and Drug Administration and who reviews the application for a drug or who participated in other dispute resolution under clause (ix) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under clause (iv) to review a dispute about the risk evaluation and mitigation strategy for such drug.

(xi)

Additional expertise

The Drug Safety Oversight Board may add members from offices within the Food and Drug Administration with relevant expertise, including the Office of Pediatrics, the Office of Women's Health, or the Office of Rare Diseases, for a meeting under clause (iv) of the Drug Safety Oversight Board.

(G)

Process for addressing Drug Class Effects

(i)

In General

When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has convened, after appropriate public notice, one or more public meetings to consider possible responses to such concern.

(ii)

Public Meetings

Such public meetings may include—

(I)

one or more meetings of the applicants for such drugs;

(II)

one or more meetings of an appropriate advisory committee of the Food and Drug Administration; or

(III)

one or more workshops of scientific experts and other stakeholders.

(iii)

Action

After considering the discussions from any meetings under clause (ii), 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.

(H)

International Coordination

To the extent practicable, the Secretary shall coordinate elements of the risk evaluation and mitigation strategy for a drug, such as the timetable for submission of assessments under paragraph (3)(E), a study under paragraph (4)(D), or a clinical trial under paragraph (4)(E), with efforts to manage 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.

(I)

Effect

Use of the processes described in subparagraphs (G) and (H) shall not delay action on an application or a supplement to an application for a drug.

(J)

No effect on labeling changes that do not require preapproval

In the case of a labeling change to which section 314.70 of title 21, Code of Federal Regulations (or any successor regulation), applies for which the submission of a supplemental application is not required or for which distribution of the drug involved may commence upon the receipt by the Secretary of a supplemental application for the change, the submission of an assessment of the approved risk evaluation and mitigation strategy for the drug under this subsection is not required.

.

102.

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:

(x)

If it is a drug subject to an approved risk evaluation and mitigation strategy under section 505(o) and the applicant for such drug fails to—

(1)

make a labeling change required by such strategy after the Secretary has completed review of, and acted on, an assessment of such strategy under paragraph (6) of such section; or

(2)

comply with a requirement of such strategy with respect to advertising as provided for under subparagraph (F), (G), or (H) of paragraph (4) of such section.

.

(b)

Civil penalties

Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended—

(1)

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

(2)

by inserting after paragraph (2) the following:

(3)

An applicant (as such term is used in section 505(o)) who knowingly fails to comply with a requirement of an approved risk evaluation and mitigation strategy under such section 505(o) shall be subject to a civil money penalty of not less than $15,000 and not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding.

;

(3)

in paragraph (2)(C), by striking paragraph (3)(A) and inserting paragraph (4)(A);

(4)

in paragraph (4), as so redesignated, by striking paragraph (1) or (2) each place it appears and inserting paragraph (1), (2), or (3); and

(5)

in paragraph (6), as so redesignated, by striking paragraph (4) each place it appears and inserting paragraph (5).

103.

Conforming amendments

(a)

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)

Risk evaluation and mitigation strategy

A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application a proposed risk evaluation and mitigation strategy as described under section 505(o) of the Federal Food, Drug, and Cosmetic Act.

; and

(2)

in subsection (j), by inserting , including the requirements under section 505(o) of such Act, after , and Cosmetic Act.

(b)

Preclearance of advertisement

Section 502(n)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)(3)(A)) is amended by inserting (or when required under section 505(o)(4)(F)) after except in extraordinary circumstances.

(c)

Content of a new drug application

Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended—

(1)

in subparagraph (F), by striking and; and

(2)

in subparagraph (G), by striking the period and inserting the following: , and (H) a proposed risk evaluation and mitigation strategy as described under subsection (o)..

(d)

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 subsection (b) or (j), 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 subsection (o)(6)(B)(i)(V)..

(e)

Drugs subject to an abbreviated new drug application

Section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding at the end the following:

(D)

Risk evaluation and mitigation strategy requirement

A drug that is the subject of an abbreviated new drug application under this subsection shall be subject to each element of the risk evaluation and mitigation strategy required under subsection (o) for the applicable listed drug, except for any post-approval clinical trial requirement described under paragraph (4)(E) of such subsection.

.

104.

Resources

(a)

User fees

Subparagraph (F) of section 735(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(6)) is amended to read as follows:

(F)

Reviewing and implementing risk evaluation and mitigation strategies, and collecting, developing, and reviewing safety information on drugs, including adverse event reports.

.

(b)

Public accountability

Section 505(a) of the Prescription Drug User Fee Amendments of 2002 (Subtitle A of title V of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188)) is amended by adding at the end the following:

(3)

Drug safety

The recommendations under paragraph (1) shall include estimates of the amounts by which the fee revenue amounts for fiscal years 2008 through 2012 should be increased to review and implement risk evaluation and mitigation strategies, and to collect, develop, and review safety information on drugs, including adverse event reports.

.

(c)

Strategic Plan for information technology

Not later than 1 year after the date of enactment of this title, the Secretary of Health and Human Services (referred to in this Act as the Secretary) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a strategic plan on information technology that includes—

(1)

an assessment of the information technology infrastructure, including data collection and data mining systems, needed by the Food and Drug Administration to comply with the requirements of this title (and the amendments made by this title), to establish standards to achieve interoperability, and to move toward electronic health records;

(2)

an assessment of the extent to which the current information technology assets of the Food and Drug Administration are sufficient to meet the needs assessment under paragraph (1);

(3)

a plan for enhancing the information technology assets of the Food and Drug Administration toward meeting the needs assessment under paragraph (1); and

(4)

an assessment of additional resources needed to so enhance the information technology assets of the Food and Drug Administration.

105.

Drug labeling

(a)

Accessible repository of drug labeling

Not later than the effective date of this title, the Secretary, through the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall establish a searchable repository of structured, electronic product information, including the approved professional labeling and any required patient labeling of each drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) in order to improve patient safety through accessible product information, support initiatives to improve patient care by better management of health care information, and provide standards for drug information. Such repository shall be made publicly accessible on the Internet website of the National Library of Medicine and through a link on the homepage of the Internet website of the Food and Drug Administration.

(b)

Posting upon approval

The Secretary shall post in the repository under subsection (a) the approved professional labeling and any required patient labeling of a drug approved under such section 505 or licensed under such section 351 not later than 21 days after the date the drug is approved, including in a supplemental application with respect to a labeling change.

(c)

Report

The Secretary shall report annually to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate on the status of the repository under subsection (a), and on progress in posting structured electronic product information, including posting of information regarding drugs approved prior to the effective date of this title.

(d)

Medication guides

Not later than the effective date of this title, the Secretary, through the Commissioner of Food and Drugs, shall establish on the Internet website page for the repository under subsection (a) a link to a list of each drug, whether approved under such section 505 or licensed under such section 351, for which a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations), is required.

106.

Effective date and applicability

(a)

Effective date

This title shall take effect 180 days after the date of 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 title and for which there are in effect on the effective date of this title restrictions on distribution and use required under section 314.520 or section 600.42 of title 21, Code of Federal Regulations, or otherwise agreed to by the applicant and the Secretary for such drug, shall be deemed to have an approved risk evaluation and mitigation strategy under such section 505(o) of the Federal Food, Drug, and Cosmetic Act (as added by this title).

(2)

Risk evaluation and mitigation strategy

The approved risk evaluation and mitigation strategy deemed in effect for a drug under paragraph (1) shall consist of the elements described in subparagraphs (A) and (B) of paragraph (3) of such section 505(o) and any other additional elements under paragraphs (4) and (5) in effect for such drug on the effective date of this title.

(3)

Notification

Not later than 30 days after the effective date of this title, the Secretary shall notify the applicant for each drug described in paragraph (1)—

(A)

that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; and

(B)

of the date, which shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (6)(B) of such section 505(o).

(4)

Enforcement Only after Assessment and Review

Neither the Secretary nor the Attorney General may seek to enforce a requirement of a risk evaluation and mitigation strategy deemed in effect under paragraph (1) before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505(o).

(c)

Other drugs approved before the effective date

The Secretary, on a case-by-case basis, may require the applicant for a drug approved before the effective date of this title to which subsection (b) does not apply to submit a proposed risk evaluation and mitigation strategy in accordance with the timeframes provided for in subclause (III), (IV), or (V), as applicable, of paragraph (6)(B)(i) of such section 505(o) if the Secretary determines that—

(1)

an element described under paragraph (3)(A) of such section 505(o) may require modification; or

(2)

a standard for adding an element described in paragraph (4) or (5) of such section 505(o) that is not in effect with respect to such drug may apply to such drug.

II

Reagan-Udall Institute for Applied Biomedical Research

201.

The Reagan-Udall Institute for Applied Biomedical Research

(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:

H

Establishment of Reagan-Udall Institute for Applied Biomedical Research

760.

Establishment and functions of the Institute

(a)

In general

There is established within the Food and Drug Administration an Institute to be known as the Reagan-Udall Institute for Applied Biomedical Research (referred to in this subchapter as the Institute). The Institute shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e).

(b)

Purpose of Institute

The purpose of the Institute is to advance the Critical Path Initiative of the Food and Drug Administration to modernize medical product development, accelerate innovation, and enhance product safety by—

(1)

initiating, sponsoring, and organizing collaborative and multidisciplinary research in the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs;

(2)

ensuring the broad participation of academic, government, and industrial researchers in the work of the Institute; and

(3)

ensuring the maximum distribution and utilization of the outcomes of such research, including through publication of research results and dissemination of intellectual property generated by the Institute.

(c)

Duties of the Institute

The Institute shall—

(1)

establish goals and priorities relating to the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs;

(2)

identify unmet needs in the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs;

(3)

in consultation with the National Institutes of Health, assess existing and proposed Federal intramural and extramural research and development programs relating to such sciences, facilitate and encourage interagency coordination of such programs, and participate in such programs relating to such sciences, including—

(A)

the identification and validation of biomarkers for use in diagnostic, device, biologic, and drug development;

(B)

the development and validation of animal models for human disease;

(C)

pharmacogenomics and inter-individual variability in drug and biologic response;

(D)

the development of data analysis technology for use in device, biologic, and drug development;

(E)

advancing improvements to the design and conduct of clinical trials;

(F)

toxicological quality assessment technologies;

(G)

device manufacturing, design and materials science;

(H)

failure mode assessment for product development;

(I)

improving adverse event reporting and analysis;

(J)

bridging engineering data and clinical performance for devices; and

(K)

computer modeling;

(4)

award grants to, or enter into contracts or cooperative agreements with, scientists and entities to advance the purposes of the Institute pursuant to the processes established in the by-laws under subsection (d)(2)(A);

(5)

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;

(6)

ensure that—

(A)

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

(B)

action is taken as necessary to enable the licensing of inventions developed by the Institute or with funds from the Institute; 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 Institute consistent with subsection (b)(3);

(7)

recruit scientists and hold or sponsor (in whole or in part) meetings as appropriate to further the purposes of the Institute;

(8)

provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies regarding how to ensure that regulatory policy accommodates scientific advances;

(9)

conduct annual evaluations of research activities that are supported by the Institute; and

(10)

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

(d)

Board of directors

(1)

Establishment

(A)

In general

The Institute 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—

(i)

the immediate past Chair of Board of Directors of the Institute;

(ii)

the Commissioner of Food and Drugs; and

(iii)

the Director of the National Institutes of Health.

(C)

Appointed members

(i)

In general

The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 12 individuals. Of such appointed members—

(I)

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

(II)

3 shall be representatives of academic research organizations;

(III)

2 shall be representatives of Government agencies, including the Food and Drug Administration and the National Institutes of Health;

(IV)

2 shall be representatives of patient advocacy organizations; and

(V)

1 shall be a representative of health care providers.

(ii)

Requirement

The ex officio members shall ensure the Board membership includes individuals with expertise in clinical pharmacology, biomedical informatics, information management, product safety, process improvement and pharmaceutical sciences, and medical device and biomedical engineering.

(2)

Duties of board

The Board shall—

(A)

establish by-laws for the Institute that—

(i)

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

(ii)

establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Institute or with Institute funds to carry out the duties described in paragraphs (5) and (6) of subsection (c);

(iii)

specify criteria and processes for the review of proposals and awarding of grants and contracts that include peer review and that are substantially consistent with those established by other government organizations, such as the National Institutes of Health and the National Science Foundation;

(iv)

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

(v)

establish specific duties of the Executive Director;

(B)

identify and prioritize the scientific needs that may be effectively and uniquely addressed by the Institute;

(C)

prioritize and provide overall direction to the research activities of the Institute;

(D)

evaluate the performance of the Executive Director; and

(E)

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

(3)

Additional board functions

(A)

In general

The Board may establish 1 or more Critical Path Institutes to conduct multidisciplinary and collaborative research, education, and outreach, and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs.

(B)

Eligibility

To be eligible to host a Critical Path Institute described in subparagraph (A), an entity shall—

(i)

be a State or local government, institution of higher education, or nonprofit entity with demonstrated ability, personnel, and clinical and other technical expertise to undertake the duties consistent with the activities in subparagraph (A); and

(ii)

submit to the Board an application at such time, in such manner, and containing such information as the Board may require.

(4)

Chair

The ex officio members of the Board under paragraph (1)(B) shall designate an appointed member of the Board to serve as the Chair of the Board.

(5)

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 ex officio members of the Board in the manner described under paragraph (1)(C)(i).

(C)

Partial term

If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed by the ex officio members of the Board in the manner described under paragraph (1)(C)(i) 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.

(6)

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)

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 Institute 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 of Food and Drugs.

(f)

Administrative powers

In carrying out this subchapter, the Board, acting through the Executive Director, may—

(1)

hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;

(2)

prescribe the manner in which—

(A)

real or personal property of the Institute is acquired, held, and transferred;

(B)

general operations of the Institute are to be conducted; and

(C)

the privileges granted to the Board by law are exercised and enjoyed;

(3)

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;

(4)

enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;

(5)

hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Institute under subsection (g);

(6)

enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Institute;

(7)

appoint other groups of advisors as may be determined necessary to carry out the functions of the Institute; and

(8)

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.

(g)

Acceptance of funds from other sources

The Executive Director may accept on behalf of the Institute, any funds, gifts, devises, or bequests of real or personal property made to the Institute from sources outside the Food and Drug Administration, including private entities, for the purposes of carrying out the duties of the Institute.

(h)

Annual reports

(1)

Reports to Institute

Any recipient of a grant, contract, or cooperative agreement from the Institute under this section shall submit to the Institute a report on an annual basis for the duration of such grant, contract, or cooperative agreement, that describes the activities carried out under such grant, contract, or cooperative agreement.

(2)

Report to Congress

Beginning with fiscal year 2008, the Executive Director shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives an annual report that—

(A)

describes the activities of the Institute and of the recipients of a grant, contract, or cooperative agreement under this section, including the practical impact of the Institute on medical product development, with emphasis on progress made by the Food and Drug Administration in incorporating Critical Path priorities to modernize medical product development, accelerate innovation, and enhance product safety;

(B)

provides a specific accounting of the source of all funds used by the Institute to carry out such activities; and

(C)

describes how such funds were used by the Institute.

(i)

Separation of funds

The Executive Director shall ensure that the funds received from the Treasury are held in separate accounts from funds received from private entities under subsection (g).

(j)

Authorization of appropriations

(1)

In general

There are authorized to be appropriated $20,000,000 for each of fiscal years 2008 through 2013 to carry out this section, section 761, and section 762.

(2)

Limitation

From amounts appropriated for a fiscal year under subparagraph (A), the Secretary shall use not less than $1,200,000 to carry out subsections (a), (b), and (d) through (i).

.

(b)

Employees from other Federal agencies

Chapter VII (21 U.S.C. 380 et seq.) (as amended by subsection (a)) is amended by adding at the end the following:

761.

Accepting employees from other Federal agencies

(a)

Collaboration with other agencies

To carry out the purposes of the Institute, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Executive Director of the Institute, may collaborate with other Federal agencies and accept the services of employees from those agencies without reimbursement to those agencies.

(b)

Detail of government employees

Not more than 5 Federal Government employees may be detailed to the Institute at any time for a period not to exceed 6 years for each such employee, and such detail shall be without civil service status or privilege. Such employees shall abide by the statutory, regulatory, ethical, and procedural standards applicable to employees of the Food and Drug Administration.

(c)

Procurement of temporary and intermittent services

The Executive Director may procure temporary and intermittent services under section 3109(b) of title 5, United States Code, at rates for individuals which do not exceed the daily equivalent of the annual rate of basic pay prescribed for level V of the Executive Schedule under section 5316 of such title.

(d)

No additional liability

Nothing in this section adds to any liability that the United States may have under chapter 171 of title 28, United States Code (commonly known as the Federal Tort Claims Act).

.

(c)

Other Institute provisions

Chapter VII (21 U.S.C. 371 et seq.) (as amended by subsection (b)) is amended by adding at the end the following:

762.

Location of Institute

(a)

In general

The Institute shall, if practicable, be located not more than 20 miles from the District of Columbia.

(b)

Use of space

The Secretary shall consult with the Administrator of General Services to ensure the most cost-efficient arrangement for the leasing or purchase of real property for adequate facilities which, if practicable, shall be located at the Food and Drug Administration, to meet the needs of the Institute in carrying out this subchapter.

.

(d)

Recovery and retention of fees for FOIA requests

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

763.

Recovery and retention of fees for freedom of information requests to the Institute

(a)

In general

The Secretary, acting through the Commissioner of Food and Drugs, may—

(1)

set and charge fees, in accordance with section 552(a)(4)(A) of title 5, United States Code, to recover all reasonable costs incurred in processing requests made under section 552 of title 5, United States Code, for records obtained or created by the Institute under this Act or any other Federal law for which responsibility for administration has been delegated to the Institute by the Secretary;

(2)

retain all fees charged for such requests; and

(3)

establish an accounting system and procedures to control receipts and expenditures of fees received under this section.

(b)

Use of fees

The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made available to carry out other provisions of this Act.

(c)

Waiver of fees

Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5, United States Code.

.

III

Clinical trials

301.

Clinical trial registry database and clinical trial results database

(a)

In general

Section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) is amended to read as follows:

(j)

Clinical trial registry database; clinical trial results database

(1)

Definitions; requirement

(A)

Definitions

In this subsection:

(i)

Clinical trial information

The term clinical trial information means those data elements that are necessary to complete an entry in the clinical trial registry database under paragraph (2) or the clinical trial results database under paragraph (3), as applicable.

(ii)

Completion date

The term completion date means, with respect to a clinical trial, the date on which the last patient enrolled in the clinical trial has completed his or her last medical visit of the clinical trial (known as last patient last visit), whether the clinical trial concluded according to the prespecified protocol plan or was terminated.

(iii)

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.

(iv)

Responsible party

The term responsible party, with respect to a clinical trial of a drug, means the sponsor of the clinical trial or the principal investigator of such clinical trial if so designated by such sponsor.

(B)

Requirement

The Secretary shall develop a mechanism by which—

(i)

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); and

(ii)

other Federal agencies may identify the responsible party for an applicable clinical trial.

(2)

Clinical trial registry database

(A)

Applicable clinical trial

(i)

In general

For purposes of this paragraph the term applicable clinical trial means—

(I)

an interventional clinical trial conducted before the drug is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act that is—

(aa)

a therapeutic or chemopreventive exploratory clinical trial to verify the efficacy and establish appropriate doses for the drug; or

(bb)

a therapeutic or chemopreventive confirmatory clinical trial;

(II)

a clinical trial conducted after the drug is approved under such section 505 or licensed under such section 351; or

(III)

a pharmacokinetic study to support a pediatric indication for the drug.

(ii)

Exception

A clinical trial under clause (i)(I)(aa) does not include—

(I)

an exploratory clinical trial that is intended solely to assess safety or solely to evaluate pharmacokinetics; or

(II)

an observational study.

(B)

Establishment

(i)

In general

To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall establish and administer a clinical trial registry database in accordance with this subsection (referred to in this subsection as the registry database). The Director of NIH shall ensure that the registry database is made publicly available through the Internet.

(ii)

Content

The Secretary shall promulgate regulations for the submission to the registry database of clinical trial information that—

(I)

conforms to the International Clinical Trials Registry Platform trial registration data set of the World Health Organization;

(II)

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, specifies whether or not there is a mechanism to access the drug outside of the clinical trial for those who do not qualify for enrollment in the clinical trial and how to obtain information about such a mechanism; and

(III)

requires the inclusion of such other data elements to the registry database as appropriate.

(C)

Format and structure

(i)

Searchable categories

The Director of NIH shall ensure that the public may search the entries in the registry database by—

(I)
(aa)

the indication being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors; or

(bb)

the safety issue being studied in the clinical trial;

(II)

enrollment status of the clinical trial; and

(III)

the sponsor of the clinical trial.

(ii)

Format

The Director of the NIH shall ensure that the registry database is easily used by patients, and that entries are easily compared.

(D)

Data submission

The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry database the clinical trial information described in subparagraph (B)(ii).

(E)

Truthful clinical trial information

(i)

In general

The clinical trial information submitted by a responsible party under this paragraph shall not be false or misleading in any particular.

(ii)

Effect

Clause (i) shall not have the effect of requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial.

(F)

Changes in clinical trial status

(i)

Enrollment

The responsible party for an applicable clinical trial shall update the enrollment status not later than 30 days after the enrollment status of such clinical trial changes.

(ii)

Completion

The responsible party for an applicable clinical trial shall report to the Director of NIH that such clinical trial is complete not later than 30 days after the completion date of the clinical trial.

(G)

Timing of submission

The clinical trial information for an applicable clinical trial required to be submitted under this paragraph shall be submitted not later than 14 days after the first patient is enrolled in such clinical trial.

(3)

Clinical trials results database

(A)

Applicable clinical trial

(i)

In general

For purposes of this paragraph, the term applicable clinical trial means—

(I)

an interventional clinical trial conducted before the drug is approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act that is—

(aa)

a therapeutic or chemopreventive confirmatory clinical trial;

(bb)

a clinical trial for a drug approved as a fast-track product under section 506 of the Federal Food, Drug, and Cosmetic Act, if such clinical trial is used to form the primary basis of an efficacy claim for such drug; or

(cc)

if required by the Secretary under subparagraph (G)(i), a clinical trial described in paragraph (2)(A)(i)(I)(aa);

(II)

a clinical trial completed after the drug is approved under such section 505 or licensed under such section 351; or

(III)

a pharmacokinetic study to support a pediatric indication for the drug.

(ii)

Exception

A clinical trial under clause (i) does not include—

(I)

an exploratory clinical trial that is intended solely to assess safety or solely to evaluate pharmacokinetics; or

(II)

an observational study.

(B)

Establishment

To ensure that results of clinical trials are made public and that patients and providers have current information regarding the results of clinical trials, the Secretary, acting through the Director of NIH, shall establish and administer a clinical trial results database in accordance with this subsection (referred to in this subsection as the results database).

(C)

Searchable categories

The Director of NIH shall ensure that the public may search the entries in the results database by—

(i)
(I)

the indication studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors; or

(II)

the safety issue studied in the clinical trial;

(ii)

whether an application for the tested indication is approved, pending approval, withdrawn, or not submitted;

(iii)

the phase of the clinical trial;

(iv)

the name of the drug that is the subject of the clinical trial; and

(v)

within the documents described in subclauses (II) and (III) of subparagraph (D)(ii)—

(I)

the sponsor of the clinical trial; and

(II)

each financial sponsor of the clinical trial.

(D)

Contents

(i)

In general

The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the results database the clinical trial information described in clause (ii).

(ii)

Required elements

In submitting clinical trial information for an applicable clinical trial to the Director of NIH for inclusion in the results database, the responsible party shall include, with respect to such clinical trial, the following information:

(I)

The information described in clauses (i) through (iv) of subparagraph (C).

(II)

A non-promotional summary document that is written in non-technical, understandable language for patients that includes the following:

(aa)

The purpose of the clinical trial.

(bb)

The sponsor of the clinical trial.

(cc)

A point of contact for information about the clinical trial.

(dd)

A description of the patient population tested in the clinical trial.

(ee)

A general description of the clinical trial and results, including a description of and the reasons for any changes in the clinical trial design that occurred since the date of submission of clinical trial information for inclusion in the registry database established under paragraph (2) and a description of any significant safety information.

(III)

A non-promotional summary document that is technical in nature that includes the following:

(aa)

The purpose of the clinical trial.

(bb)

The sponsor of the clinical trial.

(cc)

Each financial sponsor of the clinical trial.

(dd)

A point of contact for scientific information about the clinical trial.

(ee)

A description of the patient population tested in the clinical trial.

(ff)

A general description of the clinical trial and results, including a description of and the reasons for any changes in the clinical trial design that occurred since the date of submission of clinical trial information for the clinical trial in the registry database established under paragraph (2).

(gg)

Summary data describing the results, including—

(AA)

whether the primary endpoint was achieved, including relevant statistics;

(BB)

an assessment of any secondary endpoints, if applicable, including relevant statistics; and

(CC)

any significant safety information, including a summary of the incidence of serious adverse events observed in the clinical trial and a summary of the most common adverse events observed in the clinical trial and the frequencies of such events.

(IV)

A link to available peer-reviewed publications based on the results of the clinical trial, if any.

(V)

The completion date of the clinical trial.

(VI)

A link to the Internet web posting of any adverse regulatory actions taken by the Food and Drug Administration, such as a warning letter, that was substantively based on the clinical trial design, outcome, or representation made by the applicant about the design or outcome of the clinical trial.

(E)

Timing

A responsible party shall submit to the Director of NIH for inclusion in the results database clinical trial information for an applicable clinical trial not later than 1 year after the completion date of the clinical trial as reported under paragraph (2)(F)(ii).

(F)

Truthful clinical trial information

(i)

In general

The clinical trial information submitted by a responsible party under this paragraph shall not be false or misleading in any particular.

(ii)

Effect

Clause (i) shall not have the effect of requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial.

(G)

Inclusion of earlier clinical trials

(i)

In general

The Secretary may, subject to clause (ii), require through rulemaking the submission of clinical trial information for the clinical trials described in paragraph (2)(A)(i)(I)(aa) to the Director of NIH for inclusion in the results database.

(ii)

Conditions for requiring inclusion of earlier trials

The Secretary may promulgate regulations pursuant to clause (i) if—

(I)

the Comptroller General of the United States has submitted to the Secretary the report described under clause (iii); and

(II)

such report recommends the inclusion in the results database of clinical trial information for the clinical trials described under paragraph (2)(A)(i)(I)(aa).

(iii)

Study by GAO

Not earlier than 2 years after the results database has been established, the Comptroller General of the United States shall initiate a report that—

(I)

evaluates the operation of the database, including with respect to cost, burden on drug sponsors and agencies, and the value to patients and health care providers of inclusion in the results database of clinical trial information with respect to clinical trials described in paragraph (2)(A)(i)(I)(aa);

(II)

recommends whether or not clinical trial information for such clinical trials should be included in the results database;

(III)

if the recommendation under subclause (II) is to include the clinical trial information for such clinical trials in the results database, recommends whether such information should be included in the same format as the clinical trial information of other applicable clinical trials, or if modifications are necessary;

(IV)

provides recommendations for any modifications described under subclause (III); and

(V)

is submitted to the Committee on Health, Education, Labor, and Pensions of the Senate, the Committee on Energy and Commerce of the House of Representatives, and the Secretary.

(H)

Change in regulatory status

The responsible party for an applicable clinical trial shall update the regulatory status submitted under subparagraph (C)(ii) of a drug that is the subject of an applicable clinical trial within 30 days of a change in such status.

(I)

Public availability of results

(i)

Pre-approval studies

Except as provided in clause (iv), 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, the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial not later than 30 days after—

(I)

the drug is approved under such section 505 or licensed under such section 351; or

(II)

the Secretary issues a not approvable letter for the drug under such section 505 or such section 351.

(ii)

Post-approval studies

Except as provided in clauses (iii) and (iv), with respect to an applicable clinical trial that is completed after the drug is initially approved under such section 505 or initially licensed under such section 351, the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial not later than 30 days after the date of such submission.

(iii)

Seeking approval of a new use for the drug

(I)

In general

If the manufacturer of the drug is the sponsor or a financial sponsor of the applicable clinical trial, and such manufacturer certifies to the Director of NIH that such manufacturer has filed, or will file within 1 year, an application seeking approval under such section 505 or licensing under such section 351 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug), then the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial on the earlier of the date that is 30 days after the date—

(aa)

the application is approved under such section 505 or licensed such section 351;

(bb)

the Secretary issues a not approvable letter for the application under such section 505 or such section 351; or

(cc)

the application under such section 505 or such section 351 is withdrawn.

(II)

Limitation on certification

A manufacturer shall not make a certification under subclause (I) with respect to an applicable clinical trial unless the manufacturer makes such a certification with respect to each applicable clinical trial that is required to be submitted in an application for approval of the use studied in the clinical trial involved.

(III)

2 year limitation

The clinical trial information subject to subclause (I) shall be made publicly available on the results database on the date that is 2 years after the date that the clinical trial information was required to be submitted to the Director of NIH if a regulatory action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.

(iv)

Seeking publication

(I)

In general

If the principal investigator of the applicable clinical trial is seeking publication in a peer-reviewed biomedical journal of a manuscript based on the results of the clinical trial and the responsible party so certifies to the Director of NIH—

(aa)

the responsible party shall notify the Director of NIH of the publication date of such manuscript not later than 15 days after such date; and

(bb)

the Director of NIH shall make publicly available on the results database the clinical trial information submitted for such clinical trial on the date that is 30 days after the publication date of such manuscript.

(II)

Limitation

The clinical trial information subject to subclause (I) shall be made publicly available on the results database on the date that is 2 years after the date that the clinical trial information was required to be submitted to the Director of NIH if the manuscript referred to in such subclause has not been published by such date.

(J)

Verification of submission prior to public availability

In the case of clinical trial information that is submitted under this paragraph, but is not made publicly available pending either regulatory action or publication under clause (iii) or (iv) of subparagraph (I), as applicable, the Director of NIH shall respond to inquiries from other Federal agencies and peer-reviewed journals to confirm that such clinical trial information has been submitted but has not yet been made publicly available on the results database.

(4)

Coordination and compliance

(A)

Clinical trials supported by grants from Federal agencies

(i)

In general

No Federal agency may release funds under a research grant to a person who has not complied with paragraphs (2) and (3) for any applicable clinical trial for which such person is the responsible party.

(ii)

Grants from certain Federal agencies

If an applicable clinical trial is funded in whole or in part by a grant from the National Institutes of Health, the Agency for Healthcare Research and Quality, or the Department of Veterans Affairs, 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).

(iii)

Verification by Federal agencies

The heads of the agencies referred to in clause (ii), 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 paragraph (2) and (3), as applicable, before releasing funding for a grant to such grantee.

(iv)

Notice and opportunity to remedy

If the head of an agency referred to in clause (ii), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (iii), 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.

(v)

Consultation with other Federal agencies

The Secretary shall—

(I)

consult with other agencies that conduct human studies in accordance with part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such studies are applicable clinical trials under paragraph (2) or (3); and

(II)

develop with such agencies procedures comparable to those described in clauses (ii), (iii), and (iv) to ensure that clinical trial information for such applicable clinical trials is submitted under paragraphs (2) and (3).

(B)

Coordination of registry database and results database

(i)

In general

Each entry in the registry database under paragraph (2) shall include a link to the corresponding entry in the results database under paragraph (3).

(ii)

Missing entries

(I)

In general

If, based on a review of the entries in the registry database under paragraph (2), the Director of NIH determines that a responsible party has failed to submit required clinical trial information to the results database under paragraph (3), the Director of NIH shall inform the responsible party involved of such failure and permit the responsible party to correct the failure within 30 days.

(II)

Failure to correct

If the responsible party does not correct a failure to submit required clinical trial information within the 30-day period described under subclause (I), the Director of NIH shall report such non-compliance to the scientific peer review committees of the Federal research agencies and to the Office of Human Research Protections.

(III)

Public notice of failure to correct

The Director of NIH shall include in the clinical trial registry database entry and the clinical trial results database entry for each such clinical trial a notice of any uncorrected failure to submit required clinical trial information and shall provide that the public may easily search for such entries.

(C)

Action on applications

(i)

Verification prior to filing

The Secretary, acting through the Commissioner of Food and Drugs, shall verify that the clinical trial information required under paragraphs (2) and (3) for an applicable clinical trial is submitted pursuant to such applicable paragraph—

(I)

when considering a drug for an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act, including as the drug progresses through the clinical trials described under paragraph (2)(A)(i); and

(II)

prior to filing an application under section 505 of the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act that includes information from such clinical trial.

(ii)

Notification

If the responsible party has not submitted such clinical trial information, the Secretary shall notify the applicant and the responsible party of such non-compliance and require submission of such results within 30 days.

(iii)

Refusal to file

If the responsible party does not remedy such non-compliance within 30 days of receipt of notification under clause (ii), the Secretary shall refuse to file such application.

(D)

Content review

(i)

In general

To assure that the summary documents described in paragraph (3)(D) are non-promotional, and are not false or misleading in any particular under paragraph (3)(F), the Secretary shall compare such documents to the results data of the clinical trial for a representative sample of applicable clinical trials by—

(I)

acting through the Commissioner of Food and Drugs to examine the results data for such clinical trials submitted to Secretary when such data are submitted—

(aa)

for review as part of an application under section 505 of the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act; or

(bb)

in an annual status report on the drug under such application;

(II)

acting through the Inspector General of the Department of Health and Human Services and with the Federal agency that funds such clinical trial in whole or in part by a grant to examine the results data for such clinical trials; and

(III)

acting through inspections under section 704 of the Federal Food, Drug, and Cosmetic Act to examine results data for such clinical trials not described in subclause (I) or (II).

(ii)

Notice of non-compliance

If the Secretary or Inspector General of the Department of Health and Human Services determines that the clinical trial information submitted in such a summary document is promotional, or false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such non-compliance by submitting the required revised clinical trial information within 30 days of such notification.

(E)

Penalty for non-compliance

In determining whether to apply a penalty under section 301(ii) of the Federal Food, Drug, and Cosmetic Act, the Secretary, acting through the Commissioner of Food and Drugs, shall consider—

(i)

whether the responsible party promptly corrects the non-compliance when provided notice;

(ii)

whether the responsible party has engaged in a pattern or practice of non-compliance; and

(iii)

the extent to which the noncompliance involved may have significantly misled healthcare providers or patients concerning the safety or effectiveness of the drug involved.

(5)

Limitation on disclosure of clinical trial information

Disclosure to the public of clinical trial information submitted to the Director of NIH under this subsection and requested under section 552 of title 5, United States Code (commonly known as the Freedom of Information Act) shall be made only as provided for under paragraphs (2) and (3).

(6)

Authorization of appropriations

There are authorized to be appropriated to carry out this subsection such sums as may be necessary.

.

(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:

(ii)
(1)

The failure to submit clinical trial information as required by section 402(j) of the Public Health Service Act.

(2)

The submission of clinical trial information under section 402(j) of the Public Health Service Act that is promotional or false or misleading in any particular under paragraph (2)(E) or (3)(F) of such section 402(j).

.

(2)

New drugs

(A)

Investigational new drugs

Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended—

(i)

in paragraph (1)—

(I)

in subparagraph (C), by striking and after the semicolon;

(II)

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

(III)

by adding at the end the following:

(E)

the submission to the Director of NIH of clinical trial information for the clinical investigation at issue required under section 402(j) of the Public Health Service Act for inclusion in the registry database and the results database described in such section.

;

(ii)

in paragraph (3)(B)—

(I)

in clause (i), by striking or after the semicolon;

(II)

in clause (ii), by striking the period at the end and inserting ; or; and

(III)

by adding at the end the following:

(iii)

clinical trial information for the clinical investigation at issue was not submitted in compliance with section 402(j) of the Public Health Service Act.

; and

(iii)

in paragraph (4), by adding at the end the following: The Secretary shall update such regulations to require inclusion in the informed consent form a statement that clinical trial information for such clinical investigation will be submitted for inclusion in the registry database and results database, as applicable, described in section 402(j) of the Public Health Service Act..

(B)

Refusal to approve application

Section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended—

(i)

in the first sentence, by inserting after or any particular; the following: or (8) the applicant failed to submit the clinical trial information for any applicable clinical trial submitted as part of the application to the Director of the National Institutes of Health in compliance with section 402(j) of the Public Health Service Act;; and

(ii)

in the second sentence, by striking clauses (1) through (6) and inserting (1) through (8).

(c)

Guidance

Not later than 180 days after the date of enactment of this Act, the Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, shall issue guidance to clarify which clinical trials are applicable clinical trials (as defined in section 402(j)(2) of the Public Health Service Act, as amended by this section) (42 U.S.C. 282(j)(2)) and are required to be submitted for inclusion in the clinical trial registry database described in such section 402(j)(2).

(d)

Preemption

(1)

In general

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 section 402(j) of the Public Health Service Act (as amended by this section) (42 U.S.C. 282(j)), that relates to a use of a drug not included in the labeling of the approved drug shall not be construed by the Secretary or in any administrative or judicial proceeding, as evidence of a new intended use of the drug that is different from the intended use of the drug set forth in the official labeling of the drug. The availability of clinical trial information through the databases under paragraphs (2) and (3) of such section 402(j), if submitted in compliance with such section 402(j), shall not be considered as labeling, adulteration, or misbranding of the drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(e)

Effective dates

(1)

Establishment of registry database and results database

Not later than 1 year after the date of enactment of this Act, the Director of NIH shall establish the registry database and the results database of clinical trials of drugs in accordance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) (as amended by subsection (a)).

(2)

Clinical trials initiated prior to operation of registry database

The responsible party (as defined in such section 402(j)) for an applicable clinical trial under paragraph (2) of such section 402(j) that is initiated after the date of enactment of this Act and before the date such registry database is established under paragraph (1) of this subsection, shall submit required clinical trial information not later than 120 days after the date such registry database is established.

(3)

Clinical trials initiated after operation of registry database

The responsible party (as defined in such section 402(j)) for an applicable clinical trial under paragraph (2) of such section 402(j) that is initiated after the date such registry database is established under paragraph (1) of this subsection shall submit required clinical trial information in accordance with such paragraph (2).

(4)

Trials completed before operation of results database

(A)

In general

Paragraph (3) of such section 402(j) shall take effect 90 days after the date the results database is established under paragraph (1) of this subsection with respect to any applicable clinical trial (as defined in such section 402(j)(3)) that—

(i)

involves a drug to treat a serious and life-threatening condition; and

(ii)

is completed between the date of enactment of this section and such date of establishment under paragraph (1) of this subsection.

(B)

Other trials

Except as provided in subparagraph (A), paragraph (3) of such section 402(j) shall take effect 180 days after the date that the results database is established under paragraph (1) of this subsection with respect to any applicable clinical trial (as defined in such section 402(j)(3)) that is completed between the date of enactment of this Act and such date of establishment under paragraph (1).

(C)

Trials submitted in an application

Except as provided in subparagraph (A), paragraph (3) of such section 402(j) shall take effect for any clinical trial if—

(i)

such clinical trial would otherwise be an applicable clinical trial under paragraph (3) except for its date of completion; and

(ii)

data from such clinical trial is submitted in an application or supplement to an application under section 505 of the Food, Drug, and Cosmetic Act or under section 351 of the Public Health Service Act that—

(I)

is submitted 180 days or more after the date that the results database is established under paragraph (1) of this subsection; and

(II)

contains data from an applicable clinical trial.

(5)

Trials completed after establishment of results database

Paragraph (3) of such section 402(j) shall apply to any applicable clinical trial that is completed after the date that the results database is established under paragraph (1) of this subsection.

(6)

Funding restrictions

Subparagraph (A) of paragraph (4) of such section 402(j) shall take effect 210 days after the date that the clinical trial registry database and the clinical trial results database are established under paragraph (1) of this subsection.

(7)

Status of clinicaltrials.gov website

(A)

In general

After receiving public comment and not later than 90 days after the date of enactment of this Act, the Secretary shall publish in the Federal Register a notice determining the more efficient approach to establishing the registry database described in paragraph (2) of such section 402(j) and whether such approach is—

(i)

that such registry database should expand and build upon the database described in section 402(j) of the Public Health Service Act (as in effect on the day before the date of enactment of this Act); or

(ii)

that such registry database should supplant the database described in such section 402(j) (as in effect on the day before the date of enactment of this Act).

(B)

Clinicaltrials.gov supplanted

If the Secretary determines to apply the approach described under subparagraph (A)(ii), the Secretary shall maintain an archive of the database described in such section 402(j) (as in effect on the day before the date of enactment of this Act) on the Internet website of the National Library of Medicine.

IV

Conflicts of interest

401.

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)

Involvement

The term involvement means any financial interest in—

(A)

a product that is under consideration by a panel;

(B)

a competing product of such a product;

(C)

the sponsor of such product; or

(D)

the sponsor of such a competing product.

(2)

Panel

The term panel means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof, that is established by statute or by the Secretary to provide advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(3)

Product

The term product means a food, drug, biological product, device, or electronic product that is regulated by the Food and Drug Administration.

(b)

Appointments to panels

(1)

Disclosure

Prior to appointment to a panel, each candidate member of a panel shall disclose to the Secretary all involvements that such candidate may have with the work likely to be undertaken by the panel during the term of the appointment for which the candidate is under consideration.

(2)

Evaluation and criteria

When considering an appointment to a panel, the Secretary—

(A)

shall review the expertise and potential involvements of the candidate for appointment relative to the scope of work likely to be undertaken by the panel during the term of the appointment for which the candidate is under consideration, so as to—

(i)

maximize to the extent practicable the appointment of qualified individuals with no involvements, or only potential involvements of low magnitude, with such work; and

(ii)

minimize to the extent practicable the appointment of individuals with potential involvements of high magnitude with such work; and

(B)

may appoint 2 or more qualified individuals with similar expertise and non-overlapping or minimally overlapping potential involvements, so as to minimize the likelihood that a panel will need the expertise of an appointed individual who requires a waiver for service on the panel at a meeting of such panel.

(c)

Disclosure by panel member

(1)

In general

Prior to a meeting of a panel, each member of such panel shall disclose to the Secretary all involvements that such member may have with the work to be undertaken by such panel at such meeting.

(2)

Determination by Secretary with respect to panel meetings

(A)

In general

The Secretary shall make a determination with respect to each panel member based on the expertise of such panel member and the disclosure under paragraph (1). Such a determination shall be in one of the following categories:

(i)

Approval for service

The Secretary shall make the determination of approval for service for a panel member if there are no involvements or if the involvements of the panel member are of low magnitude.

(ii)

Approval for service with a waiver or limited waiver

The Secretary shall make the determination of approval for service with a waiver or limited waiver for a panel member if the involvements of the panel member are of medium or high magnitude and the Secretary certifies in writing that—

(I)

such waiver is necessary to provide the panel with essential expertise; or

(II)

the need for the individual's service outweighs the potential for a conflict of interest created by the disclosed involvements.

(iii)

Recusal

The Secretary shall make the determination of recusal for a panel member if the involvements of the panel member are of medium or high magnitude but a waiver or limited waiver could not be granted under clause (ii) because the criteria for certification by the Secretary under such clause were not met.

(B)

Notice of determination

(i)

More than 15 days in advance

A soon as practicable, but in no case later than 15 days prior to a meeting of a panel to which a determination for a panel member under clause (ii) or (iii) of subparagraph (A) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)) on the Internet website of the Food and Drug Administration—

(I)

the type of the involvements;

(II)

the nature of the involvements;

(III)

the magnitude of the involvements; and

(IV)

the reasons for any determination of the Secretary under such clause (ii).

(ii)

Less than 15 days in advance

In the case of a conflict of interest that becomes known to the Secretary less than 15 days prior to a meeting to which the determination under clause (ii) or (iii) of subparagraph (A) applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)) on the Internet website of the Food and Drug Administration, the information described in subclauses (I) through (IV) of clause (i) of this subparagraph as soon as practicable, but in no event later than the date of such meeting.

(d)

Limitations

In no case—

(1)

may the Secretary grant a waiver under subsection (c)(2) for a panel member if the scientific work of such member is under consideration by the panel; or

(2)

may a panel member vote with respect to any matter considered by the panel if such panel member or an immediate family member of such panel member could gain financially from the advice given to the Secretary with respect to such matter.

(e)

Public record

The Secretary shall ensure that the public record of each meeting of a panel includes a description of any determination of the Secretary made under subsection (c)(2), including the category of such determination and the involvements of each panel member (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)).

.

(b)

Guidance

(1)

Nominations

Not later than 270 days after the date of enactment of this Act the Secretary shall publish in the Federal Register for public comment a proposed mechanism for encouraging the nomination of individuals who are classified by the Food and Drug Administration as academicians or practitioners for service on a panel (as defined in section 712 of the Federal Food, Drug, and Cosmetic Act (as added by this section)).

(2)

Conflict of interest determinations

Not later than 270 days after the date of enactment of this Act the Secretary shall issue or revise guidance—

(A)

that defines the circumstances that, taking into consideration the categories of determination under subsection (c) of section 712 of the Federal Food, Drug, and Cosmetic Act (as added by this section)—

(i)

favor the inclusion of an individual on a panel;

(ii)

favor a waiver of a conflict of interest requirement for an individual on a panel;

(iii)

favor a limited waiver of a conflict of interest requirement for an individual on a panel; and

(iv)

disfavor the inclusion of an individual on a panel;

(B)

that gives greater priority to consideration of an individual's net worth over consideration of absolute dollar value of an involvement in evaluating the magnitude of an involvement for purposes of making a determination under such subsection (c);

(C)

that defines how financial interests imputed to an individual bear upon his or her eligibility for service on a panel or for service at a meeting of a panel;

(D)

that clarifies and improves the processes to ensure disclosure of, and to verify the accuracy of, financial interests imputed to an individual; and

(E)

to ensure consistency within and among the centers of the Food and Drug Administration in the issuance of determinations under such subsection (c).

(3)

Periodic review

At least once every 5 years, the Secretary shall review the guidance described under paragraph (2) and update such guidance as necessary.

(c)

Review by inspector general

(1)

In general

The Inspector General of the Department of Health and Human Services shall, on a periodic basis, conduct a review of the current financial interests, which shall be disclosed to the Inspector General in the same format and manner as under subsection (c) of section 712 of the Federal Food, Drug, and Cosmetic Act (as added by this section), of a representative sample of individuals who have completed service on such a panel (as defined in such section 712).

(2)

Submission of report

As part of the semiannual report required under section 5 of the Inspector General Act of 1978 (5 U.S.C. App.), the Inspector General of the Department of Health and Human Services shall include any findings with respect to an individual being rewarded or otherwise compensated by a sponsor of a product or a sponsor of a competing product in exchange for the individual's vote as a member of a panel of the Food and Drug Administration which considered the product or a competing product (as such terms are used in such section 712), or the absence of any such findings.

(d)

Conforming amendment

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.

(e)

Effective date

The amendments made by this section shall take effect on October 1, 2007.