I

106TH CONGRESS

2D SESSION H. R. 5231

To amend the Federal Food, Drug, and Cosmetic Act and title 35, United

States Code, with respect to abbreviated applications for the approval

of new drugs.

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 20, 2000

Mr. MOLLOHAN (for himself and Mr. CALVERT) 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 amend the Federal Food, Drug, and Cosmetic Act and

title 35, United States Code, with respect to abbreviated

applications for the approval of new 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 ‘‘Pharmaceutical Re5 form Act of 2000’’.
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1 SEC. 2. AMENDMENTS REGARDING ABBREVIATED APPLICA2 TIONS FOR APPROVAL OF NEW DRUGS.

3 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—

4 The Federal Food, Drug, and Cosmetic Act (21 U.S.C.

5 301 et seq.) is amended—

6 (1) in section 306(f), by adding at the end the

7 following paragraph:

8 ‘‘(4) LIMITATION.—The Secretary shall

9 cease consideration of a petition under para10 graph (1), and shall terminate any order under

11 such paragraph issued in response to the peti12 tion, if the Secretary determines that the per13 son submitting the petition received, as an in14 ducement for submitting the petition, valuable

15 consideration provided directly or indirectly by

16 an entity any of whose financial interests are

17 served by the issuance of an order under such

18 paragraph.’’; and

19 (2) in section 505(j)—

20 (A) in paragraph (2), by adding at the end

21 the following subparagraph:

22 ‘‘(D) For purposes of subparagraph (A)(vii), a patent

23 may not be considered to claim a listed drug unless with

24 respect to such drug the patent claims an active ingre25 dient.’’;
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1 (B) in paragraph (5)(B)(iii), in the second

2 sentence, in the matter preceding subclause (I),

3 by striking ‘‘If such an action’’ and all that fol4 lows through ‘‘, except that’’ and inserting the

5 following: ‘‘If such an action is brought before

6 the expiration of such days, the approval shall

7 be made effective upon the expiration of such

8 period as the court may designate, consistent

9 with chapters 28 and 29 of title 35, United

10 States Code, and taking into account whether

11 the parties to the action reasonably cooperate in

12 expediting the action (which period shall begin

13 on the date of the receipt of the notice provided

14 under paragraph (2)(B)(i)), except that’’;

15 (C) in paragraph (5)(B)(iv)—

16 (i) in the matter preceding subclause

17 (I), by striking ‘‘a certification,’’ and in18 serting ‘‘a certification and has been ap19 proved,’’; and

20 (ii) by amending subclause (I) to read

21 as follows:

22 ‘‘(I) the date on which the Secretary ap23 proved the previous application,’’;

24 (D) in paragraph (7)(A)(i), in the matter

25 preceding subclause (I), by striking ‘‘the Sec-
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1 retary shall publish’’ and inserting the fol2 lowing: ‘‘the Secretary, in consultation with the

3 Commissioner of Patents and Trademarks,

4 shall publish’’; and

5 (E) by adding at the end the following

6 paragraph:

7 ‘‘(10)(A) No State or political subdivision of a State

8 may establish or continue in effect with respect to a drug

9 approved under this subsection any requirement that is

10 different from, or in addition to, any requirement applica11 ble under this Act to the drug.

12 ‘‘(B) Pursuant to subparagraph (A), no State or po13 litical subdivision of a State may establish or continue in

14 effect with respect to a drug approved under this sub15 section any prohibition against the use of the drug as a

16 substitute for any listed drug to which the drug is thera17 peutically equivalent as determined by the Secretary, in18 cluding therapeutic equivalence evaluated by the Secretary

19 as having an AB code (relating to actual or potential bio20 equivalence problems that have been resolved with ade21 quate evidence that supports bioequivalence).’’.

22 (b) TITLE 35, UNITED STATES CODE.—Section

23 271(e)(1) of title 35, United States Code, is amended by

24 striking ‘‘a Federal law which regulates’’ and inserting the
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1 following: ‘‘a Federal law, or a law of a foreign country,

2 which regulates’’.

3 (c) SENSE OF CONGRESS.—It is the sense of the Con4 gress that section 351(j) of the Public Health Service Act

5 (as added by section 123(g) of the Food and Drug Admin6 istration Modernization Act of 1997; 111 Stat. 2324) au7 thorizes the submission, under section 505(j) of the Fed8 eral Food, Drug, and Cosmetic Act, of an abbreviated ap9 plication for the approval of a new drug that is a biological

10 product.

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