I

106TH CONGRESS

2D SESSION H. R. 5235

To ensure the timely availability of generic drugs through enhancement of

drug approval and antitrust laws enforced by the Food and Drug Administration and the Federal Trade Commission regarding brand name drugs

and generic drugs.

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 20, 2000

Mr. WAXMAN (for himself, Mr. STARK, Mr. BROWN of Ohio, Mr. BERRY, Mr.

COBURN, and Mr. DEUTSCH) introduced the following bill; which was referred to the Committee on Commerce, and in addition to the Committee

on the Judiciary, for a period to be subsequently determined by the

Speaker, in each case for consideration of such provisions as fall within

the jurisdiction of the committee concerned

A BILL

To ensure the timely availability of generic drugs through

enhancement of drug approval and antitrust laws enforced by the Food and Drug Administration and the

Federal Trade Commission regarding brand name drugs

and generic drugs.

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 may be cited as the ‘‘Prescription Drug

5 Competition Act of 2000’’.
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1 SEC. 2. FINDINGS.

2 Congress finds that—

3 (1) prescription drug costs are increasing at an

4 alarming rate and are a major concern of senior citi5 zens and American families;

6 (2) there is a potential for drug companies own7 ing patents on brand-name drugs to enter to private

8 financial deals with generic drug companies in a

9 manner that could tend to restrain trade and greatly

10 reduce competition and increase prescription drug

11 costs for American citizens; and

12 (3) enhancing competition between generic drug

13 manufacturers and brand name manufacturers can

14 significantly reduce prescription drug costs to Amer15 ican families.

16 SEC. 3. PURPOSE.

17 The purposes of this Act are—

18 (1) to provide timely notice to the Food and

19 Drug Administration and the Federal Trade Com20 mission regarding agreements between companies

21 owning patents on branded drugs and companies

22 who could manufacture generic or bioequivalent

23 versions of such branded drugs; and

24 (2) by providing timely notice, to—

25 (A) ensure the prompt availability of safe

26 and effective generic drugs;
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1 (B) enhance the effectiveness and effi2 ciency of the enforcement of the antitrust laws

3 of the United States; and

4 (C) deter pharmaceutical companies from

5 engaging in anticompetitive actions or actions

6 that tend to unfairly restrain trade.

7 SEC. 4. DEFINITIONS.

8 In this Act:

9 (1) AGREEMENT.—The term ‘‘agreement’’

10 means an agreement under section 1 of the Sherman

11 Act (15 U.S.C. 1) or section 5 of the Federal Trade

12 Commission Act (15 U.S.C. 45).

13 (2) ANTITRUST LAWS.—The term ‘‘antitrust

14 laws’’ has the same meaning as in section 1 of the

15 Clayton Act (15 U.S.C. 12), except that such term

16 includes section 5 of the Federal Trade Commission

17 Act (15 U.S.C. 45) to the extent that such section

18 applies to unfair methods of competition.

19 (3) ANDA.—The term ‘‘ANDA’’ means an Ab20 breviated New Drug Application, as defined under

21 section 505(j) of the Federal Food, Drug and Cos22 metic Act.

23 (4) BRAND NAME DRUG COMPANY.—The term

24 ‘‘brand name drug company’’ means a person en25 gaged in the manufacture or marketing of a drug
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1 approved under section 505(b) of the Federal Food,

2 Drug and Cosmetic Act.

3 (5) COMMISSION.—The term ‘‘Commission’’

4 means the Federal Trade Commission.

5 (6) FDA.—The term ‘‘FDA’’ means the United

6 States Food and Drug Administration.

7 (7) GENERIC DRUG.—The term ‘‘generic drug’’

8 means a product that is the subject of an ANDA.

9 (8) GENERIC DRUG APPLICANT.—The term

10 ‘‘generic drug applicant’’ means a person who has

11 filed or received approval for an ANDA under sec12 tion 505(j) of the Federal Food, Drug and Cosmetic

13 Act.

14 (9) SECRETARY.—The term ‘‘Secretary’’ means

15 the Secretary of Health and Human Services.

16 SEC. 5. NOTIFICATION OF AGREEMENTS AFFECTING THE

17 SALE OR MARKETING OF GENERIC DRUGS.

18 A brand name drug company and a generic drug ap19 plicant that enter into an agreement regarding the sale

20 or manufacture of a generic drug that the Secretary has

21 determined is the therapeutic equivalent of a brand name

22 drug that is manufactured or marketed by that brand

23 name drug company, or for which the generic drug appli24 cant seeks such a determination of therapeutic equiva25 lence, and which agreement could have the effect of lim-
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1 iting the research, development, manufacture, marketing,

2 or selling of a generic drug that has been or could be ap3 proved for sale by the FDA pursuant to an ANDA, shall

4 file with the Commission and the Secretary the text of

5 the agreement, an explanation of the purpose and scope

6 of the agreement, and an explanation of whether the

7 agreement could delay, restrain, limit, or in any way inter8 fere with the production, manufacture, or sale of the ge9 neric version of the drug in question.

10 SEC. 6. FILING DEADLINES.

11 Any notice, agreement, or other material required to

12 be filed under section 5 shall be filed with the Commission

13 and the Secretary not later than 10 business days after

14 the date the agreement is executed.

15 SEC. 7. ENFORCEMENT.

16 (a) CIVIL FINE.—Any person, or any officer, direc17 tor, or partner thereof, who fails to comply with any provi18 sion of this Act shall be liable for a civil penalty of not

19 more than $20,000 for each day during which such person

20 is in violation of this Act. Such penalty may be recovered

21 in a civil action brought by the United States, or brought

22 by the Commission in accordance with the procedures es23 tablished in section 16(a)(1) of the Federal Trade Com24 mission Act (15 U.S.C. 56(a)).
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1 (b) COMPLIANCE AND EQUITABLE RELIEF.—If any

2 person, or any officer, director, partner, agent, or em3 ployee thereof, fails to comply with the notification re4 quirement under section 5 of this Act, the United States

5 district court may order compliance, and may grant such

6 other equitable relief as the court in its discretion deter7 mines necessary or appropriate, upon application of the

8 Commission or the Assistant Attorney General.

9 SEC. 8. RULEMAKING.

10 The Commission, in consultation with the Secretary,

11 and with the concurrence of the Assistant Attorney Gen12 eral and by rule in accordance with section 553 of title

13 5, United States Code, consistent with the purposes of this

14 Act—

15 (1) may require that the notice described in sec16 tion 5 of this Act be in such form and contain such

17 documentary material and information relevant to

18 the agreement as is necessary and appropriate to en19 able the Commission and the Assistant Attorney

20 General to determine whether such agreement may

21 violate the antitrust laws;

22 (2) may define the terms used in this Act;

23 (3) may exempt classes of persons or agree24 ments from the requirements of this Act; and
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1 (4) may prescribe such other rules as may be

2 necessary and appropriate to carry out the purposes

3 of this Act.

4 SEC. 9. EFFECTIVE DATES.

5 This Act shall take effect 90 days after the date of

6 enactment of this Act.

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