II

106TH CONGRESS

2D SESSION S. 3208

To amend the Federal Food, Drug, and Cosmetic Act to enhance consumer

protection in the purchase of prescription drugs from interstate Internet

sellers.

IN THE SENATE OF THE UNITED STATES

OCTOBER 17 (legislative day, SEPTEMBER 22), 2000

Mr. JEFFORDS (for himself, Mr. KENNEDY, and Mr. DODD) 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

enhance consumer protection in the purchase of prescription drugs from interstate Internet sellers.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act be cited as the ‘‘Internet Prescription Drug

5 Consumer Protection Act of 2000’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress makes the following find8 ings:
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1 (1) Legitimate Internet sellers of prescription

2 drugs can offer substantial benefits to consumers.

3 These potential benefits include convenience, pri4 vacy, valuable information, competitive prices, and

5 personalized services.

6 (2) Unlawful Internet sellers of prescription

7 drugs may dispense inappropriate, contaminated,

8 counterfeit, or subpotent prescription drugs that

9 could put at risk the health and safety of consumers.

10 (3) Unlawful Internet sellers have exposed con11 sumers to significant health risks by knowingly fill12 ing invalid prescriptions, such as prescriptions based

13 solely on an online questionnaire, or by dispensing

14 prescription drugs without any prescription.

15 (4) The ease with which web sites can be cre16 ated and removed and the lack of readily available

17 information to identify Internet sellers creates sig18 nificant barriers to effective law enforcement efforts

19 against unlawful Internet sellers.

20 (5) Consumers may have difficulty distin21 guishing legitimate from unlawful Internet sellers, as

22 well as foreign from domestic Internet sellers, of

23 prescription drugs.

24 (6) States need additional enforcement tools to

25 take effective action against unlawful domestic
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1 Internet sellers and the Federal agencies need addi2 tional enforcement tools to take effective action

3 against unlawful foreign Internet sellers.

4 (b) PURPOSE.—The purpose of this Act is to provide

5 Federal and State law enforcement with adequate tools to

6 take effective action against interstate Internet sellers of

7 prescription drugs who illegally sell such drugs to con8 sumers in the United States and to protect such con9 sumers against potential harms that may result from pur10 chasing such drugs from such sellers.

11 SEC. 3. AMENDMENT TO THE FEDERAL FOOD, DRUG, AND

12 COSMETIC ACT.

13 (a) IN GENERAL.—Chapter V of the Federal Food,

14 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend15 ed by inserting after section 503A the following:

16 ‘‘SEC. 503B. INTERNET PRESCRIPTION DRUG SALES.

17 ‘‘(a) DEFINITIONS.—For purposes of this section:

18 ‘‘(1) CONSUMER.—The term ‘consumer’ means

19 a person (other than an entity licensed or otherwise

20 authorized under Federal or State law as a phar21 macy or to dispense or distribute prescription drugs)

22 that purchases or seeks to purchase prescription

23 drugs through the Internet.
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1 ‘‘(2) HOME PAGE.—The term ‘home page’

2 means the entry point or main web page for an

3 Internet site.

4 ‘‘(3) INTERNET.—The term ‘Internet’ means

5 collectively the myriad of computer and tele6 communications facilities, including equipment and

7 operating software, which comprise the inter8 connected worldwide network of networks that em9 ploy the Transmission Control Protocol/Internet

10 Protocol, or any predecessor or successor protocols

11 to such protocol, to communicate information of all

12 kinds by wire or radio, including electronic mail.

13 ‘‘(4) INTERSTATE INTERNET SELLER.—

14 ‘‘(A) IN GENERAL.—The term ‘interstate

15 Internet seller’ means a person whether in the

16 United States or abroad, that engages in, offers

17 to engage in, or causes the delivery or sale of

18 a prescription drug through the Internet and

19 has such drug delivered directly to the con20 sumer via the Postal Service, or any private or

21 commercial interstate carrier to a consumer in

22 the United States who is residing in a State

23 other than the State in which the seller’s place

24 of business is located. This definition excludes

25 a person who only delivers a prescription drug
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1 to a consumer, such as an interstate carrier

2 service.

3 ‘‘(B) EXEMPTION.—With respect to the

4 consumer involved, the term ‘interstate Internet

5 seller’ does not include a person described in

6 subparagraph (A) whose place of business is lo7 cated within 75 miles of the consumer.

8 ‘‘(5) LINK.—The term ‘link’ means either a

9 textual or graphical marker on a web page that,

10 when clicked on, takes the consumer to another part

11 of the Internet, such as to another web page or a

12 different area on the same web page, or from an

13 electronic message to a web page.

14 ‘‘(6) PHARMACY.—The term ‘pharmacy’ means

15 any place licensed or otherwise authorized as a phar16 macy under State law.

17 ‘‘(7) PRESCRIBER.—The term ‘prescriber’

18 means an individual, licensed or otherwise author19 ized under applicable Federal and State law to issue

20 prescriptions for prescription drugs.

21 ‘‘(8) PRESCRIPTION DRUG.—The term ‘pre22 scription drug’ means a drug under section

23 503(b)(1).

24 ‘‘(9) VALID PRESCRIPTION.—The term ‘valid

25 prescription’ means a prescription that meets the re-
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1 quirements of section 503(b)(1) and other applicable

2 Federal and State law.

3 ‘‘(10) WEB SITE; SITE.—The terms ‘web site’

4 and ‘site’ mean a specific location on the Internet

5 that is determined by Internet protocol numbers or

6 by a domain name.

7 ‘‘(b) REQUIREMENTS FOR INTERSTATE INTERNET

8 SELLERS.—

9 ‘‘(1) IN GENERAL.—Each interstate Internet

10 seller shall comply with the requirements of this sub11 section with respect to the sale of, or the offer to

12 sell, prescription drugs through the Internet and

13 shall at all times display on its web site information

14 in accordance with paragraph (2).

15 ‘‘(2) WEB SITE DISCLOSURE INFORMATION.—

16 An interstate Internet seller shall post in a visible

17 and clear manner (as determined by regulation) on

18 the home page of its web site, or on a page directly

19 linked to such home page—

20 ‘‘(A) the street address of the interstate

21 Internet seller’s place of business, and the tele22 phone number of such place of business;

23 ‘‘(B) each State in which the interstate

24 Internet seller is licensed or otherwise author25 ized as a pharmacy, or if the interstate Internet
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1 seller is not licensed or otherwise authorized by

2 a State as a pharmacy, each State in which the

3 interstate Internet seller is licensed or otherwise

4 authorized to dispense prescription drugs, and

5 the type of State license or authorization;

6 ‘‘(C) in the case of an interstate Internet

7 seller that makes referrals to or solicits on be8 half of a prescriber, the name of each pre9 scriber, the street address of each such pre10 scriber’s place of business, the telephone num11 ber of such place of business, each State in

12 which each such prescriber is licensed or other13 wise authorized to prescribe prescription drugs,

14 and the type of such license or authorization;

15 and

16 ‘‘(D) a statement that the interstate Inter17 net seller will dispense prescription drugs only

18 upon a valid prescription.

19 ‘‘(3) DATE OF POSTING.—Information required

20 to be posted under paragraph (2) shall be posted by

21 an interstate Internet seller—

22 ‘‘(A) not later than 90 days after the effec23 tive date of this section if the web site of such

24 seller is in operation as of such date; or
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1 ‘‘(B) on the date of the first day of oper2 ation of such seller’s web site if such site goes

3 into operation after such date.

4 ‘‘(4) QUALIFYING STATEMENTS.—An interstate

5 Internet seller shall not indicate in any manner that

6 posting disclosure information on its web site sig7 nifies that the Federal Government has made any

8 determination on the legitimacy of the interstate

9 Internet seller or its business.

10 ‘‘(5) DISCLOSURE TO STATE LICENSING

11 BOARDS.—An interstate Internet seller licensed or

12 otherwise authorized to dispense prescription drugs

13 in accordance with applicable State law shall notify

14 each State entity that granted such licensure or au15 thorization that it is an interstate Internet seller,

16 the name of its business, the Internet address of its

17 business, the street address of its place of business,

18 and the telephone number of such place of business.

19 ‘‘(6) REGULATIONS.—The Secretary is author20 ized to promulgate such regulations as are necessary

21 to carry out the provisions of this subsection. In

22 issuing such regulations, the Secretary—

23 ‘‘(A) shall take into consideration disclo24 sure formats used by existing interstate Inter25 net seller certification programs; and
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1 ‘‘(B) shall in defining the term ‘place of

2 business’ include provisions providing that such

3 place is a single location at which employees of

4 the business perform job functions, and not a

5 post office box or similar locale.’’.

6 (b) STATE ENFORCEMENT OF FEDERAL LAW RE7 GARDING INTERNET SELLERS OF PRESCRIPTION

8 DRUGS.—Chapter III of the Federal Food, Drug, and

9 Cosmetic Act (21 U.S.C. 331 et seq.) is amended by add10 ing at the end the following:

11 ‘‘STATE PROCEEDINGS REGARDING INTERNET SALES OF

12 PRESCRIPTION DRUGS

13 ‘‘SEC. 310A. (a) IN GENERAL.—A State, through its

14 attorney general, may bring in its own name, and in an

15 appropriate district court of the United States, pro16 ceedings against an interstate Internet seller of a prescrip17 tion drug for the civil enforcement, or to restrain viola18 tions of section 503B(b), or paragraph (1) or (2) of sec19 tion 503(b), on behalf of consumers who reside in that

20 State and have been or are being adversely affected by

21 such violations. Through such proceedings, the State may

22 with respect to such violations—

23 ‘‘(1) obtain a permanent nationwide injunction;

24 ‘‘(2) enforce compliance; or

25 ‘‘(3) obtain such other relief as the court may

26 find appropriate.
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1 ‘‘(b) NOTICE TO SECRETARY AND APPROPRIATE

2 FEDERAL AGENCIES.—A State—

3 ‘‘(1) shall serve prior written notice of any civil

4 action under subsection (a) upon the Secretary and

5 the appropriate Federal agencies and provide to the

6 Secretary and such agencies a copy of its complaint,

7 except in any case where such prior notice is not fea8 sible, in which case the State shall serve such notice

9 immediately upon instituting such action; and

10 ‘‘(2) may proceed with the civil action unless

11 another State attorney general or a Federal agency

12 has filed a complaint against the same party for the

13 same violations under this section prior to receiving

14 notice and the civil action brought by the State at15 torney general or such agency is still ongoing or

16 there has been a final judgment.

17 ‘‘(c) RIGHTS OF PRESIDENT.—The President shall

18 have the right to intervene in any action brought under

19 subsection (a), and upon so intervening, to be heard in

20 all matters arising therein and to file notices of appeal.

21 ‘‘(d) APPLICABILITY OF SUBPOENAS.—Subpoenas

22 for witnesses who are required to attend a court of the

23 United States, in any district, may run into any other dis24 trict in any proceeding under this section.
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1 ‘‘(e) CONSTRUCTION.—For purposes of bringing any

2 civil action under subsection (a), nothing in this section

3 shall prevent a State attorney general from exercising the

4 powers conferred on the attorney general by the laws of

5 such State to conduct investigations or to administer oaths

6 or affirmations or to compel the attendance of witnesses

7 or the production of documentary or other evidence or to

8 bring an action under the laws of such State to obtain

9 remedies under that State’s laws.

10 ‘‘(f) DEFINITIONS.—For purposes of this section, the

11 terms ‘interstate Internet seller’, ‘Internet’, and ‘prescrip12 tion drug’ have the meanings given such terms in section

13 503B.’’.

14 (c) PROHIBITED ACTS.—Section 301 of the Federal

15 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend16 ed by adding at the end the following:

17 ‘‘(aa) The failure to post information required under

18 section 503B(b)(2) or knowingly making a materially false

19 statement when posting such information as required

20 under such section or violating section 503B(b)(4).’’.

21 SEC. 4. PUBLIC EDUCATION.

22 The Secretary of Health and Human Services shall

23 engage in activities to educate the public about the dan24 gers of purchasing prescription drugs from unlawful Inter25 net sources. The Secretary should educate the public
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1 about effective public and private sector consumer protec2 tion efforts, as appropriate, with input from the public and

3 private sectors, as appropriate.

4 SEC. 5. STUDY REGARDING COORDINATION OF REGU5 LATORY ACTIVITIES.

6 Not later than 180 days after the date of enactment

7 of this Act, the Secretary of Health and Human Services,

8 after consultation with the Attorney General, shall submit

9 to Congress a report providing recommendations for co10 ordinating the activities of Federal agencies regarding

11 interstate Internet sellers that operate from foreign coun12 tries and for coordinating the activities of the Federal

13 Government with the activities of governments of foreign

14 countries regarding such interstate Internet sellers.

15 SEC. 6. CIVIL ACTIONS REGARDING PROPERTY.

16 Section 303 of the Federal Food, Drug, and Cosmetic

17 Act (21 U.S.C. 333) is amended by adding at the end the

18 following subsection:

19 ‘‘(i)(1) If a person is alienating or disposing of prop20 erty, or intends to alienate or dispose of property which

21 is obtained as a result of or is traceable to a violation by

22 an interstate Internet seller of paragraph (1) or (2) of sec23 tion 503(b), the President may commence a civil action

24 in any Federal court—
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1 ‘‘(A) to enjoin such alienation or disposition of

2 property; or

3 ‘‘(B) for a restraining order to—

4 ‘‘(i) prohibit any person from withdrawing,

5 transferring, removing, dissipating, or disposing

6 of any such property or property of equivalent

7 value; and

8 ‘‘(ii) appoint a temporary receiver to ad9 minister such restraining order.

10 ‘‘(2) Proceedings under paragraph (1) shall be car11 ried out in the same manner as apply under section 1345

12 of title 18, United States Code.’’.

13 SEC. 7. EFFECTIVE DATE.

14 The amendments made by this Act shall take effect

15 6 months after the date of enactment of this Act, except

16 that the authority of the Secretary of Health and Human

17 Services to commence the process of rulemaking is effec18 tive on the date of enactment of this Act.

19 SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

20 There is authorized to be appropriated to carry out

21 this Act such sums as may be necessary.

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