[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3401 Introduced in House (IH)]
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 Representatives 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 application submitted under
paragraph (1), the Secretary 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 adding at the
end of subparagraph (A) the following:
``(ii) For purposes of clause (i), a drug is the therapeutic
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 concentration, 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 established
by paragraph (2)(A)(v)) labeling;
``(II) it is expected to have the same clinical effect and
safety profile when administered to patients under conditions
specified in the labeling; and
``(III) it either does not present a known or potential
bioequivalence problem and meets an acceptable in vitro
standard or if it does present such a problem, is shown to meet
an appropriate bioequivalence 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 subclause (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 enactment 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 involved''.
SEC. 3. STATE LAWS.
Section 505(j) of the Federal Food, Drug, and Cosmetic 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 applicable under paragraph (5)(A)(ii) to the drug.''.
<all>