I

105TH CONGRESS

2D SESSION H. R. 4849

To amend the Federal Food, Drug, and Cosmetic Act to establish therapeutic

equivalence requirements for generic drugs, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

OCTOBER 16, 1998

Mr. PALLONE introduced the following bill; which was referred to the

Committee on Commerce

A BILL

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

establish therapeutic equivalence requirements for generic

drugs, and for other purposes.

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 ‘‘Generic Drug Uni5 formity Act of 1998’’.

6 SEC. 2. THERAPEUTIC EQUIVALENCE.

7 Section 505(j)(5) of the Federal Food, Drug, and

8 Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—

9 (1) by adding at the end of subparagraph (A)

10 the following: ‘‘When the Secretary approves an ap-
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1 plication submitted under paragraph (1), the Sec2 retary shall include in such approval a finding that

3 the drug for which the application is approved is or

4 is not the therapeutic equivalent of the listed drug

5 involved.’’;

6 (2) by inserting ‘‘(i)’’ after ‘‘(A)’’ and by add7 ing at the end of subparagraph (A) the following:

8 ‘‘(ii) For purposes of clause (i), a drug is the thera9 peutic equivalent of a listed drug when, with respect to

10 the listed drug—

11 ‘‘(I) all of its active ingredients are the same,

12 it is of the same dosage form, it has the same route

13 of administration, it is identical in strength or con14 centration, and it meets the same compendial or

15 other applicable standard, except that it may differ

16 in shape, scoring, configuration, packaging,

17 excipients, expiration time, or (within the limits es18 tablished by paragraph (2)(A)(v)) labeling;

19 ‘‘(II) it is expected to have the same clinical ef20 fect and safety profile when administered to patients

21 under conditions specified in the labeling; and

22 ‘‘(III) it either does not present a known or po23 tential bioequivalence problem and meets an accept24 able in vitro standard or if it does present such a
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1 problem, is shown to meet an appropriate bioequiva2 lence standard.

3 ‘‘(iii) If a drug meets the requirements of clause (ii)

4 with respect to a listed drug, the Secretary shall include

5 in the approval of the application for the drug that it is

6 the therapeutic equivalent of the listed drug involved.’’;

7 and

8 (3) in paragraph (7)(A)(i) by striking in sub9 clause (II) ‘‘and the number of the application which

10 was approved’’ and inserting ‘‘, the number of the

11 application which was approved, and, in the case of

12 a drug that is the subject of an application approved

13 under paragraph (5)(A) after the date of the enact14 ment of the Generic Drug Uniformity Act of 1998,

15 the finding of the Secretary that the drug is or is

16 not the therapeutic equivalent of the listed drug in17 volved’’.

18 SEC. 3. STATE LAWS.

19 Section 505(j) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355(j)) is amended by adding at the

21 end the following:

22 ‘‘(10) No State or political subdivision of a State may

23 establish or continue in effect with respect to a drug for

24 which an abbreviated application may be submitted under

25 this subsection any requirement which is different from,
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1 or in addition to, any requirement related to therapeutic

2 equivalence applicable under paragraph (5)(A)(ii) to the

3 drug.’’.

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