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.
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 Drug Uni-
formity Act of 1998’’.
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 Drug Uniformity Act of 1998,
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 for
which an abbreviated application may be submitted under
this subsection any requirement which is different from,
or in addition to, any requirement related to therapeutic
equivalence applicable under paragraph (5)(A)(ii) to the
drug.’’.
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