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.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Generic Drugs Access 
Act of 2003’’. 
SEC. 2. THERAPEUTIC EQUIVALENCE. 
Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—
(1) by adding at the end of subparagraph (A) 
the following: ‘‘When the Secretary approves an ap-
plication submitted under paragraph (1), the Sec-
retary shall include in such approval a finding that 
the drug for which the application is approved is or 
is not the therapeutic equivalent of the listed drug 
involved.’’; 
(2) by inserting ‘‘(i)’’ after ‘‘(A)’’ and by add-
ing at the end of subparagraph (A) the following: 
‘‘(ii) For purposes of clause (i), a drug is the thera-
peutic equivalent of a listed drug when, with respect to 
the listed drug—
‘‘(I) all of its active ingredients are the same, 
it is of the same dosage form, it has the same route 
of administration, it is identical in strength or con-
centration, and it meets the same compendial or 
other applicable standard, except that it may differ 
in 
shape, 
scoring, 
configuration, 
packaging, 
excipients, expiration time, or (within the limits es-
tablished by paragraph (2)(A)(v)) labeling; 
‘‘(II) it is expected to have the same clinical ef-
fect and safety profile when administered to patients 
under conditions specified in the labeling; and 
‘‘(III) it either does not present a known or po-
tential bioequivalence problem and meets an accept-
able in vitro standard or if it does present such a
problem, is shown to meet an appropriate bioequiva-
lence standard. 
‘‘(iii) If a drug meets the requirements of clause (ii) 
with respect to a listed drug, the Secretary shall include 
in the approval of the application for the drug that it is 
the therapeutic equivalent of the listed drug involved.’’; 
and 
(3) in paragraph (7)(A)(i) by striking in sub-
clause (II) ‘‘and the number of the application which 
was approved’’ and inserting ‘‘, the number of the 
application which was approved, and, in the case of 
a drug that is the subject of an application approved 
under paragraph (5)(A) after the date of the enact-
ment of the Generic Drugs Access Act of 2003, the 
finding of the Secretary that the drug is or is not 
the therapeutic equivalent of the listed drug in-
volved’’. 
SEC. 3. STATE LAWS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
‘‘(10) No State or political subdivision of a State may 
establish or continue in effect with respect to a drug that 
is the subject of an application under paragraph (5)(A) 
any requirement which is different from, or in addition
to, any requirement related to therapeutic equivalence ap-
plicable under paragraph (5)(A)(ii) to the drug.’’.
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