I

106TH CONGRESS

1ST SESSION H. R. 805

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

FEBRUARY 23, 1999

Mr. PALLONE (for himself, Mr. BERRY, Mrs. CLAYTON, Mr. SHOWS, Ms. KILPATRICK, Ms. JACKSON-LEE of Texas, Mr. STARK, Ms. NORTON, Ms.

SCHAKOWSKY, Mr. RANGEL, Mr. WEINER, Mr. WAXMAN, Mr. BROWN of

Ohio, Mr. MOAKLEY, Mr. LUTHER, Mr. NADLER, Mr. HINCHEY, and Mr.

ALLEN) 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 Drugs Access

5 Act of 1999’’.

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

2 the following: ‘‘When the Secretary approves an ap3 plication submitted under paragraph (1), the Sec4 retary shall include in such approval a finding that

5 the drug for which the application is approved is or

6 is not the therapeutic equivalent of the listed drug

7 involved.’’;

8 (2) by inserting ‘‘(i)’’ after ‘‘(A)’’ and by add9 ing at the end of subparagraph (A) the following:

10 ‘‘(ii) For purposes of clause (i), a drug is the thera11 peutic equivalent of a listed drug when, with respect to

12 the listed drug—

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

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

15 of administration, it is identical in strength or con16 centration, and it meets the same compendial or

17 other applicable standard, except that it may differ

18 in shape, scoring, configuration, packaging,

19 excipients, expiration time, or (within the limits es20 tablished by paragraph (2)(A)(v)) labeling;

21 ‘‘(II) it is expected to have the same clinical ef22 fect and safety profile when administered to patients

23 under conditions specified in the labeling; and

24 ‘‘(III) it either does not present a known or po25 tential bioequivalence problem and meets an accept-
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1 able in vitro standard or if it does present such a

2 problem, is shown to meet an appropriate bioequiva3 lence standard.

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

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

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

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

8 and

9 (3) in paragraph (7)(A)(i) by striking in sub10 clause (II) ‘‘and the number of the application which

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

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

13 a drug that is the subject of an application approved

14 under paragraph (5)(A) after the date of the enact15 ment of the Generic Drugs Access Act of 1999, the

16 finding of the Secretary that the drug is or is not

17 the therapeutic equivalent of the listed drug in18 volved’’.

19 SEC. 3. STATE LAWS.

20 Section 505(j) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 355(j)) is amended by adding at the

22 end the following:

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

24 establish or continue in effect with respect to a drug that

25 is the subject of an application under paragraph (5)(A)
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1 any requirement which is different from, or in addition

2 to, any requirement related to therapeutic equivalence ap3 plicable under paragraph (5)(A)(ii) to the drug.’’.

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