HR 5476 IH

To amend the Federal Food, Drug, and Cosmetic Act to enhance consumer protection in the purchase of prescription drugs from interstate Internet sellers.

October 17, 2000

Mr. BLILEY (for himself, Mr. KLINK, and Mr. UPTON) introduced the following bill; which was referred to the Committee on Commerce

To amend the Federal Food, Drug, and Cosmetic Act to enhance consumer protection in the purchase of prescription drugs from interstate Internet sellers.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act be cited as the `Internet Prescription Drug Consumer Protection Act of 2000'.

SEC. 2. FINDINGS AND PURPOSE.

(a) FINDINGS- Congress makes the following findings:

(1) Legitimate Internet sellers of prescription drugs can offer substantial benefits to consumers. These potential benefits include convenience, privacy, valuable information, competitive prices, and personalized services.

(2) Unlawful Internet sellers of prescription drugs may dispense inappropriate, contaminated, counterfeit, or subpotent prescription drugs that could put at risk the health and safety of consumers.

(3) Unlawful Internet sellers have exposed consumers to significant health risks by knowingly filling invalid prescriptions, such as prescriptions based solely on an online questionnaire, or by dispensing prescription drugs without any prescription.

(4) The ease with which web sites can be created and removed and the lack of readily available information to identify Internet sellers creates significant barriers to effective law enforcement efforts against unlawful Internet sellers.

(5) Consumers may have difficulty distinguishing legitimate from unlawful Internet sellers, as well as foreign from domestic Internet sellers, of prescription drugs.

(6) States need additional enforcement tools to take effective action against unlawful domestic Internet sellers and the Federal agencies need additional enforcement tools to take effective action against unlawful foreign Internet sellers.

(b) PURPOSE- The purpose of this Act is to provide Federal and State law enforcement with adequate tools to take effective action against interstate Internet sellers of prescription drugs who illegally sell such drugs to consumers in the United States and to protect such consumers against potential harms that may result from purchasing such drugs from such sellers.

SEC. 3. AMENDMENT TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) IN GENERAL- Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A the following:

`SEC. 503B. INTERNET PRESCRIPTION DRUG SALES.

`(a) DEFINITIONS- For purposes of this section:

`(1) CONSUMER- The term `consumer' means a person (other than an entity licensed or otherwise authorized under Federal or State law as a pharmacy or to dispense or distribute prescription drugs) that purchases or seeks to purchase prescription drugs through the Internet.

`(2) HOME PAGE- The term `home page' means the entry point or main web page for an Internet site.

`(3) INTERNET- The term `Internet' means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocols to such protocol, to communicate information of all kinds by wire or radio, including electronic mail.

`(4) INTERSTATE INTERNET SELLER-

`(A) IN GENERAL- The term `interstate Internet seller' means a person whether in the United States or abroad, that engages in, offers to engage in, or causes the delivery or sale of a prescription drug through the Internet and has such drug delivered directly to the consumer via the Postal Service, or any private or commercial interstate carrier to a consumer in the United States who is residing in a State other than the State in which the seller's place of business is located. This definition excludes a person who only delivers a prescription drug to a consumer, such as an interstate carrier service.

`(B) EXEMPTION- With respect to the consumer involved, the term `interstate Internet seller' does not include a person described in subparagraph (A) whose place of business is located within 75 miles of the consumer.

`(5) LINK- The term `link' means either a textual or graphical marker on a web page that, when clicked on, takes the consumer to another part of the Internet, such as to another web page or a different area on the same web page, or from an electronic message to a web page.

`(6) PHARMACY- The term `pharmacy' means any place licensed or otherwise authorized as a pharmacy under State law.

`(7) PRESCRIBER- The term `prescriber' means an individual, licensed or otherwise authorized under applicable Federal and State law to issue prescriptions for prescription drugs.

`(8) PRESCRIPTION DRUG- The term `prescription drug' means a drug under section 503(b)(1).

`(9) VALID PRESCRIPTION- The term `valid prescription' means a prescription that meets the requirements of section 503(b)(1) and other applicable Federal and State law.

`(10) WEB SITE; SITE- The terms `web site' and `site' mean a specific location on the Internet that is determined by Internet protocol numbers or by a domain name.

`(b) REQUIREMENTS FOR INTERSTATE INTERNET SELLERS-

`(1) IN GENERAL- Each interstate Internet seller shall comply with the requirements of this subsection with respect to the sale of, or the offer to sell, prescription drugs through the Internet and shall at all times display on its web site information in accordance with paragraph (2).

`(2) WEB SITE DISCLOSURE INFORMATION- An interstate Internet seller shall post in a visible and clear manner (as determined by regulation) on the home page of its web site, or on a page directly linked to such home page--

`(A) the street address of the interstate Internet seller's place of business, and the telephone number of such place of business;

`(B) each State in which the interstate Internet seller is licensed or otherwise authorized as a pharmacy, or if the interstate Internet seller is not licensed or otherwise authorized by a State as a pharmacy, each State in which the interstate Internet seller is licensed or otherwise authorized to dispense prescription drugs, and the type of State license or authorization;

`(C) in the case of an interstate Internet seller that makes referrals to or solicits on behalf of a prescriber, the name of each prescriber, the street address of each such prescriber's place of business, the telephone number of such place of business, each State in which each such prescriber is licensed or otherwise authorized to prescribe prescription drugs, and the type of such license or authorization; and

`(D) a statement that the interstate Internet seller will dispense prescription drugs only upon a valid prescription.

`(3) DATE OF POSTING- Information required to be posted under paragraph (2) shall be posted by an interstate Internet seller--

`(A) not later than 90 days after the effective date of this section if the web site of such seller is in operation as of such date; or

`(B) on the date of the first day of operation of such seller's web site if such site goes into operation after such date.

`(4) QUALIFYING STATEMENTS- An interstate Internet seller shall not indicate in any manner that posting disclosure information on its web site signifies that the Federal Government has made any determination on the legitimacy of the interstate Internet seller or its business.

`(5) DISCLOSURE TO STATE LICENSING BOARDS- An interstate Internet seller licensed or otherwise authorized to dispense prescription drugs in accordance with applicable State law shall notify each State entity that granted such licensure or authorization that it is an interstate Internet seller, the name of its business, the Internet address of its business, the street address of its place of business, and the telephone number of such place of business.

`(6) REGULATIONS- The Secretary is authorized to promulgate such regulations as are necessary to carry out the provisions of this subsection. In issuing such regulations, the Secretary--

`(A) shall take into consideration disclosure formats used by existing interstate Internet seller certification programs; and

`(B) shall in defining the term `place of business' include provisions providing that such place is a single location at which employees of the business perform job functions, and not a post office box or similar locale.'.

(b) STATE ENFORCEMENT OF FEDERAL LAW REGARDING INTERNET SELLERS OF PRESCRIPTION DRUGS- Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end the following:

`STATE PROCEEDINGS REGARDING INTERNET SALES OF PRESCRIPTION DRUGS

`SEC. 310A. (a) IN GENERAL- A State, through its attorney general, may bring in its own name, and in an appropriate district court of the United States, proceedings against an interstate Internet seller of a prescription drug for the civil enforcement, or to restrain violations of section 503B(b), or paragraph (1) or (2) of section 503(b), on behalf of consumers who reside in that State and have been or are being adversely affected by such violations. Through such proceedings, the State may with respect to such violations--

`(1) obtain a permanent nationwide injunction;

`(2) enforce compliance; or

`(3) obtain such other relief as the court may find appropriate.

`(b) NOTICE TO SECRETARY AND APPROPRIATE FEDERAL AGENCIES- A State--

`(1) shall serve prior written notice of any civil action under subsection (a) upon the Secretary and the appropriate Federal agencies and provide to the Secretary and such agencies a copy of its complaint, except in any case where such prior notice is not feasible, in which case the State shall serve such notice immediately upon instituting such action; and

`(2) may proceed with the civil action unless another State attorney general or a Federal agency has filed a complaint against the same party for the same violations under this section prior to receiving notice and the civil action brought by the State attorney general or such agency is still ongoing or there has been a final judgment.

`(c) RIGHTS OF PRESIDENT- The President shall have the right to intervene in any action brought under

subsection (a), and upon so intervening, to be heard in all matters arising therein and to file notices of appeal.

`(d) APPLICABILITY OF SUBPOENAS- Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section.

`(e) CONSTRUCTION- For purposes of bringing any civil action under subsection (a), nothing in this section shall prevent a State attorney general from exercising the powers conferred on the attorney general by the laws of such State to conduct investigations or to administer oaths or affirmations or to compel the attendance of witnesses or the production of documentary or other evidence or to bring an action under the laws of such State to obtain remedies under that State's laws.

`(f) DEFINITIONS- For purposes of this section, the terms `interstate Internet seller', `Internet', and `prescription drug' have the meanings given such terms in section 503B.'.

(c) 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:

`(aa) The failure to post information required under section 503B(b)(2) or for knowingly making a materially false statement when posting such information as required under such section or violating section 503B(b)(4).'.

SEC. 4. PUBLIC EDUCATION.

The Secretary of Health and Human Services shall engage in activities to educate the public about the dangers of purchasing prescription drugs from unlawful Internet sources. The Secretary should educate the public about effective public and private sector consumer protection efforts, as appropriate, with input from the public and private sectors, as appropriate.

SEC. 5. STUDY REGARDING COORDINATION OF REGULATORY ACTIVITIES.

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, after consultation with the Attorney General, shall submit to Congress a report providing recommendations for coordinating the activities of Federal agencies regarding interstate Internet sellers that operate from foreign countries and for coordinating the activities of the Federal Government with the activities of governments of foreign countries regarding such interstate Internet sellers.

SEC. 6. CIVIL ACTIONS REGARDING PROPERTY.

Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following subsection:

`(i)(1) If a person is alienating or disposing of property, or intends to alienate or dispose of property which is obtained as a result of or is traceable to a violation by an interstate Internet seller of paragraph (1) or (2) of section 503(b), the President may commence a civil action in any Federal court--

`(A) to enjoin such alienation or disposition of property; or

`(B) for a restraining order to--

`(i) prohibit any person from withdrawing, transferring, removing, dissipating, or disposing of any such property or property of equivalent value; and

`(ii) appoint a temporary receiver to administer such restraining order.

`(2) Proceedings under paragraph (1) shall be carried out in the same manner as apply under section 1345 of title 18, United States Code.'.

SEC. 7. EFFECTIVE DATE.

The amendments made by this Act shall take effect 6 months after the date of enactment of this Act, except that the authority of the Secretary of Health and Human Services to commence the process of rulemaking is effective on the date of enactment of this Act.

SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

There is authorized to be appropriated to carry out this Act such sums as may be necessary.

END