[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.''.
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