I 

108TH CONGRESS 

1ST SESSION H. R. 3401

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 29, 2003

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

Committee on Energy and 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 2003’’. 

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 Drugs Access Act of 2003, the 

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

16 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 that 

24 is the subject of an application under paragraph (5)(A) 

25 any requirement which is different from, or in addition 
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1 to, any requirement related to therapeutic equivalence ap2 plicable under paragraph (5)(A)(ii) to the drug.’’.

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