S. 2002 (112th): Online Pharmacy Safety Act

112th Congress, 2011–2013. Text as of Dec 15, 2011 (Introduced).

Status & Summary | PDF | Source: GPO

II

112th CONGRESS

1st Session

S. 2002

IN THE SENATE OF THE UNITED STATES

December 15, 2011

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

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of Internet pharmacies.

1.

Short title

This Act may be cited as the Online Pharmacy Safety Act.

2.

Findings

Congress finds that—

(1)

consumers in the United States are targeted by organized international crime networks that use Internet websites to sell illegal and often dangerous drugs under the guise of being legitimate online pharmacies;

(2)

illegal online drug sellers offer products that do not meet the safety standards established by United States laws, and recent reports from the National Association of Boards of Pharmacy show that 92 to 95 percent of Internet websites offering to sell prescription medications online are illegitimate and operate in clear violation of United States laws enacted to protect patients;

(3)

criminals are attracted to the high profit margin of business through illegitimate online drug sales, as counterfeit drug sales alone are estimated to have generated $75,000,000,000 in 2010, an increase of 92 percent from 2005;

(4)

the World Health Organization estimates that 50 percent of the prescription medicines sold online by Internet websites that hide their physical address are counterfeit;

(5)

research by The Partnership at Drugfree.org found that 1 in 6 consumers in the United States, a total of about 36,000,000 Americans, has bought or currently buys prescription medication online without a valid prescription;

(6)

the prevalence of illegal online drug sellers, and their sale of counterfeit or otherwise illegitimate medicines, is a growing public health threat;

(7)

people have been seriously injured or killed by products sold by illegal online drug sellers;

(8)

the accessibility of controlled substances and other drugs without a valid prescription by illegal online drug sellers contributes to a growing prescription drug abuse problem in the United States that is endangering teenagers and public health;

(9)

the anonymous and unregulated nature of the Internet contributes to the counterfeit drug trade and enables counterfeit medicines to reach United States consumers through illegitimate online drug sellers posing as legitimate pharmacies;

(10)

counterfeit drugs that are sold through illegal online drug sellers are manufactured by criminals who deliberately and fraudulently misrepresent the product in order to trick consumers into thinking they are purchasing a legitimate and safe medicine;

(11)

these counterfeit drugs are frequently manufactured in unsanitary conditions and may contain the wrong ingredients, lack active ingredients, have insufficient or contaminated active ingredients, or contain too many active ingredients;

(12)

counterfeit drugs obtained from illegal online drug sellers have been found to contain harmful ingredients including arsenic, boric acid, brick dust, cement powder, chalk dust, floor polish, leaded road paint, nickel, shoe polish, and talcum powder;

(13)

United States citizens deserve access to safe and legitimate online pharmacies and protection from illegal Internet websites that sell counterfeit or otherwise illegitimate medication;

(14)

while the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Public Law 110–425) has helped to prevent illegitimate online sales of prescribed controlled substances, illegal online sellers continue to sell other types of prescription drugs and stronger laws are needed to stop them; and

(15)

greater education and awareness regarding illegal online drug sellers will help to protect the United States drug supply chain from infiltration by unregulated and counterfeit products.

3.

Valid prescriptions

Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) is amended—

(1)

in paragraph (1), in the matter following subparagraph (B), by striking shall be dispensed and all that follows through the pharmacist. and inserting the following: shall be dispensed only pursuant to a valid prescription that is (i) a written prescription of a practitioner licensed by law to administer such drug; (ii) an oral prescription of such practitioner which is reduced promptly to writing by the pharmacist; (iii) an electronic prescription issued by a practitioner licensed by law to administer such drug; or (iv) the refill of any such written, oral, or electronic prescription if such refilling is authorized by the prescriber either in the original prescription, electronic prescription, or by oral order which is reduced promptly to writing by the pharmacist.; and

(2)

by adding at the end the following:

(6)

In this paragraph:

(A)

The term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

(i)

a licensed practitioner who has conducted at least 1 in-person medical evaluation of the patient, subject to paragraph (7);

(ii)

a covering practitioner; or

(iii)

a practitioner engaged in the practice of telemedicine.

(B)
(i)

The term in-person medical evaluation means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

(ii)

Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

(C)

The term covering practitioner means, with respect to a patient, a licensed practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a licensed practitioner who—

(i)

has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(ii)

is temporarily unavailable to conduct the evaluation of the patient.

(D)

The term practice of telemedicine has the meaning given that term in section 102 of the Controlled Substances Act.

(7)

For purposes of paragraph (6), an in-person medical evaluation of the patient is not required if—

(A)

the prescribing practitioner is issuing a prescription or dispensing a legend drug in accordance with the Expedited Partner Therapy in the Management of Sexually Transmitted Diseases guidance document issued by the Centers for Disease Control and Prevention; or

(B)

the prescription, administration, or dispensing is through a public health clinic or other distribution mechanism approved by the State health authority in order to prevent, mitigate, or treat a pandemic illness, infectious disease outbreak, or intentional or accidental release of a biological, chemical, or radiological agent.

(8)

The Secretary may by regulation establish exceptions to the requirements described in paragraph (6) with respect to a drug, based on criteria established by the Secretary.

.

4.

Registry of legitimate online pharmacy websites

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 510 the following:

510A.

Registry of legitimate online pharmacy websites

(a)

Definitions

In this section:

(1)

Dispensing pharmacy

The term dispensing pharmacy means a pharmacy that dispenses, distributes, or supplies prescription drugs pursuant to orders made on, through, or on behalf of, an online pharmacy website.

(2)

Domain name

The term domain name has the meaning given that term in section 45 of the Lanham Act (15 U.S.C. 1127).

(3)

Financial transaction provider

The term financial transaction provider has the meaning given that term in section 5362(4) of title 31, United States Code.

(4)

Internet website

The term Internet website means the collection of digital assets, including links, indexes, or pointers to digital assets, accessible through the Internet that are addressed relative to a common domain name.

(5)

Legitimate online pharmacy website

The term legitimate online pharmacy website means an online pharmacy website that is included in the Registry pursuant to a designation by the Secretary under this section.

(6)

Online pharmacy website

The term online pharmacy website means an Internet website that offers, sells, dispenses, or distributes, or facilitates the sale, dispensing, or distribution of prescription or other drugs to consumers.

(7)

Prescription drug

The term prescription drug means a drug that is subject to section 503(b)(1).

(b)

Establishment of registry

The Secretary shall establish a Registry of Legitimate Online Pharmacy Websites (referred to in this section as the Registry) for the purpose of educating consumers and promoting public health and safety.

(c)

Criteria

The Secretary shall designate an online pharmacy website as a legitimate online pharmacy website, and include such legitimate online pharmacy website on the Registry, if the Secretary determines that—

(1)

the online pharmacy website is accredited by the United States National Association of Boards of Pharmacy Verified Internet Pharmacy Practice Sites program; or

(2)

the online pharmacy website meets each of the following requirements:

(A)

Prescription drugs ordered, sold, dispensed, distributed, supplied, or provided through or by the online pharmacy website are sold, dispensed, distributed, supplied, or provided solely by dispensing pharmacies that are domiciled in the United States and that maintain pharmacy licensure, a permit, or registration in good standing in all United States jurisdictions where such dispensing pharmacies provide services or are required to maintain such licensure, permit, or registration.

(B)

Each dispensing pharmacy affiliated with, or that dispenses, distributes, supplies, or provides prescription or other drugs on behalf of the online pharmacy website, maintains a valid Drug Enforcement Administration registration, unless such registration is not required by Drug Enforcement Administration regulations.

(C)

Each dispensing pharmacy affiliated with, or that dispenses, distributes, supplies, or provides prescription drugs on behalf of the online pharmacy website, dispenses, distributes, supplies, provides, or offers or attempts to dispense, distribute, supply, or provide, prescription drugs only pursuant to a valid prescription (as defined in section 503(b)).

(D)

Each dispensing pharmacy affiliated with, or that dispenses, distributes, supplies, or provides prescription drugs on behalf of the online pharmacy website, complies with applicable Federal and State laws and regulations applicable to pharmacy practice.

(E)

Each dispensing pharmacy affiliated with, or that dispenses, distributes, supplies, or provides prescription or other drugs on behalf of the online pharmacy website, does not dispense, distribute, supply, provide, offer or attempt to dispense, distribute, supply, or provide, advertise, or promote prescription or other drugs that have not been approved by the Food and Drug Administration.

(F)

The online pharmacy website prominently displays the following information:

(i)

An accurate United States street address of each dispensing pharmacy or the corporate or other legal business entity headquarters of each dispensing pharmacy.

(ii)

An accurate, readily accessible, and responsive telephone number or other secure accurate means that allows the consumer to contact or consult with the pharmacist about his or her prescription drug.

(G)

The online pharmacy website does not make any statements, regarding the nature of any dispensing pharmacy or product offered via the website, that are materially misleading or fraudulent.

(H)

The domain name registration information applicable to the online pharmacy website is accurate, not anonymous, and has a logical nexus to each dispensing pharmacy or the corporate or other legal business headquarters of each dispensing pharmacy.

(I)

The online pharmacy website, including any operator, content owner, or domain name registrant of the online pharmacy website, is not affiliated with, and does not own or control any other online pharmacy website that violates the requirements under this paragraph.

(J)

The online pharmacy website, including any operator, content owner, or domain name registrant of the online pharmacy website, is not affiliated with, and does not own or control any other online pharmacy website that violates Federal or State law.

(K)

Information that would be considered protected health information under the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (commonly referred to as the HIPAA Privacy Rule) is transmitted by the online pharmacy website and each dispensing pharmacy affiliated with, or that dispenses, distributes, supplies, or provides prescription drugs on behalf of the online pharmacy website, in accordance with the requirements of such Act, including the use of Secure-Socket Layer or equivalent technology for the transmission of protected health information, and the online pharmacy website displays its privacy policy and that such policy complies with the requirements of the HIPAA Privacy Rule.

(L)

The online pharmacy website complies with other requirements as determined appropriate by the Secretary, in consultation with other Federal and State agencies responsible for regulating the practice of pharmacy.

(d)

Process

(1)

Application

The Secretary shall develop an application process through which an interested operator, content owner, or domain name registrant of an online pharmacy website may apply for inclusion on the Registry. Such an application shall be submitted in such form and manner as required by the Secretary and shall include, at a minimum, information to determine whether the online pharmacy website satisfies the criteria described under subsection (c). The Secretary shall not charge a fee for submission of an application.

(2)

Identification without application

(A)

In general

The Secretary shall take reasonable steps to identify online pharmacy websites for which no application has been submitted under paragraph (1) and evaluate whether these online pharmacy websites satisfy the criteria described under subsection (c).

(B)

Compliance confirmed

In cases where satisfaction of the criteria described under subsection (c) can be verified without the receipt of an application, an online pharmacy website that the Secretary determines to satisfy such criteria may be designated as a legitimate online pharmacy website and included on the Registry and the operator, content owner, or domain name registrant of such online pharmacy website shall be notified of such placement.

(C)

Additional information required

In cases where satisfaction of the criteria described under subsection (c) cannot be verified without additional information or some corrective action by the online pharmacy website operator, content owner, or domain name registrant, the online pharmacy website shall not be designated as a legitimate online pharmacy website or placed on the Registry until the additional information is received by the Secretary and the Secretary determines that all applicable and necessary corrective actions have been taken.

(3)

Regulations regarding application process

(A)

In general

The Secretary shall promulgate regulations—

(i)

to establish the timeframes applicable to informing online pharmacy website operators, content owners, or domain name registrants that submit an application under paragraph (1) of the acceptance or denial of such application;

(ii)

to address what information may be shared with or withheld from online pharmacy website operators, content owners, or domain name registrants that submit such an application regarding corrective actions that would need to be taken to establish compliance with the Registry requirements;

(iii)

to establish an appeal process giving online pharmacy website operators, content owners, or domain name registrants that submit such an application the ability to request a second review of the application to determine compliance with the Registry requirements; and

(iv)

to address other procedural matters regarding the receipt and evaluation of applications submitted under paragraph (1) as the Secretary determines necessary.

(B)

Limitation regarding appeals process

The appeals process established under subparagraph (A)(iii) shall in no case require the Secretary—

(i)

to disclose information that may impede an ongoing or potential criminal or regulatory investigation; or

(ii)

to provide an opportunity for appeal in cases where the Secretary determines, in the Secretary’s sole discretion, that the violation of a Registry requirement is materially significant, such a violation is not likely to be curable, or the applicant has engaged in a pattern of violations of Federal or State law.

(4)

Authority and process for removal from registry

(A)

In general

The Secretary shall have the authority to remove an online pharmacy website from the Registry—

(i)

upon determination that the online pharmacy website is not in compliance with the criteria as established by this section;

(ii)

upon determination that the online pharmacy website was mistakenly included in the Registry; or

(iii)

for good cause as determined by the Secretary based on credible evidence.

(B)

Process

If the Secretary determines that an online pharmacy website shall be removed from the Registry under subparagraph (A), the Secretary shall provide notice to the operator, content owner, or domain name registrant of the online pharmacy website of the determination, the date of the removal of the website from the Registry, and the reasons for removal.

(C)

Regulations for appeal process

(i)

In general

The Secretary shall promulgate regulations that provide the operator, content owner, or domain name registrant of an online pharmacy website removed from the Registry the ability to appeal the removal and to provide information to correct matters that served as basis for removal from the Registry. Such regulations shall provide a reasonable time period to correct the grounds for removal.

(ii)

Limitation regarding appeals process

The appeals process established under clause (i) shall in no case require the Secretary—

(I)

to disclose information that may impede an ongoing or potential criminal or regulatory investigation; or

(II)

to provide an opportunity for appeal in cases where the Secretary determines, in the Secretary’s sole discretion, that the violation of a Registry requirement is materially significant, such a violation is not likely to be curable, or the applicant has engaged in a pattern of violations of Federal or State law.

(e)

Contracts with private entities

(1)

In general

The Secretary may enter into contracts with the United States National Association of Boards of Pharmacy or other private entities to—

(A)

review applications submitted under subsection (d)(1) and evaluate whether the online pharmacy website satisfies the criteria described under subsection (c);

(B)

on an ongoing basis, review and identify online pharmacy websites for which no application has been submitted under subsection (d)(1) and evaluate whether these online pharmacies satisfy the criteria described under subsection (c);

(C)

make recommendations to the Secretary as to whether an online pharmacy website, either through application or through identification under subparagraph (B), satisfies the criteria under subsection (c);

(D)

notify the Food and Drug Administration of online pharmacy websites that do not to satisfy such criteria; and

(E)

provide services to maintain the Registry.

(2)

Contracting

In contracting with entities under this subsection, the Secretary—

(A)

may waive such provisions of the Federal Acquisition Regulation, except for provisions relating to confidentiality of information, as necessary for the efficient implementation of this subsection and for selecting such entities; and

(B)

shall select entities that have demonstrated a history of competency in reviewing, evaluating, and determining the legitimacy of online pharmacy websites, based on standards approved by the United States National Association of Boards of Pharmacy.

(3)

Terms of contract

A contract with an entity under this subsection shall include such terms and conditions as specified by the Secretary, including the following:

(A)

The entity shall monitor the Internet on an ongoing basis in order to sufficiently maintain a current list of legitimate online pharmacy websites for consideration by the Secretary.

(B)

On at least a monthly basis, the entity shall submit to the Secretary an updated list of legitimate online pharmacy websites recommended for inclusion on the Registry.

(f)

Use of registry

(1)

Public availability

The Secretary shall—

(A)

make the Registry available to Internet advertising services, financial transaction providers, domain name registries, domain name registrars, other domain name authorities, information location tool service providers, and others as determined necessary and appropriate by the Secretary to promote public health and safety;

(B)

make the Registry available to consumers and other interested persons through publication on the Internet website of the Food and Drug Administration; and

(C)

specify the Registry criteria used to designate legitimate online pharmacy websites on the Internet website of the Food and Drug Administration.

(2)

Consumer education

The Secretary shall—

(A)

engage in a campaign to educate consumers on the availability and use of the Registry to promote public health and safety through means as determined appropriate and necessary by the Secretary, which may include radio, television, print media, and Internet public service announcements; and

(B)

make consumer education materials available, on the Internet website of the Food and Drug Administration and in a consumer-friendly form and manner, regarding how to safely purchase drugs over the Internet.

(g)

Refusal of service; immunity

(1)

Refusal of service

A domain name registry, domain name registrar, other domain name authority, financial transaction provider, information location tool service provider, or Internet advertising service, acting in good faith based on the Registry, may cease or refuse to provide services to an online pharmacy website that is not included on the Registry.

(2)

Immunity from liability

An entity described in paragraph (1), including the directors, officers, employees, or agents of such entity, that, acting in good faith, ceases or refuses to provide services to an online pharmacy website that is not listed on the Registry shall not be liable to any party under any Federal or State law for such action.

(3)

Immunity from suit

No cause of action shall lie in any court or administrative agency against any entity described in paragraph (1), including the directors, officers, employees, or agents of such entity, that, acting in good faith, ceases or refuses to provide services to an online pharmacy website that is not included on the Registry.

.

5.

Funding

There is authorized to be appropriated such sums as may be necessary to carry out this Act (and the amendments made by this Act).

6.

Effective date

This Act (and the amendments made by this Act) shall take effect on the date that is 180 days after the date of enactment of this Act.