[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4332 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 4332
To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to
extend the period for a first applicant, with respect to a generic
drug, to obtain tentative approval without forfeiting the 180-day
exclusivity period, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 29, 2012
Mr. Pallone (for himself and Mr. Guthrie) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to
extend the period for a first applicant, with respect to a generic
drug, to obtain tentative approval without forfeiting the 180-day
exclusivity period, 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 Drug Application Review
Fairness Act of 2012''.
SEC. 2. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN TENTATIVE
APPROVAL WITHOUT FORFEITING 180-DAY EXCLUSIVITY PERIOD.
(a) Extension of Period.--
(1) In general.--Subclause (IV) of section 505(j)(5)(D)(i)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(5)(D)(i)) is amended to read as follows:
``(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 60 months after the
date on which--
``(aa) the application is
filed and initially contains a
certification described in
paragraph (2)(A)(vii)(IV), or
``(bb) the application is
amended to first contain such a
certification,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is so filed or
amended.''.
(2) Applicability.--
(A) In general.--Subject to subsection (b), the
amendment made by paragraph (1) applies--
(i) only with respect to an application
that is filed under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) on or after the day that is 30 months
prior to the date of the enactment of this Act;
and
(ii) only if no certification under
paragraph (2)(A)(vii)(IV) of such section
505(j) was made before such day with respect to
the listed drug (as such term is used in such
section 505(j)).
(B) Certain applications.--If an application was
filed under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) prior to the day
specified in subparagraph (A)(i) and, on such day,
contained a certification described in paragraph
(2)(A)(vii)(IV), the application shall be subject to
paragraph (5)(D)(i)(IV) of such section 505(j) as in
effect on the day before the date of the enactment of
this Act.
(b) Incremental Reduction of Extended Period.--
(1) Period duration.--
(A) Effective on October 1, 2013, subclause (IV) of
section 505(j)(5)(D)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)), as amended by
subsection (a)(1), is amended by striking ``60 months''
and inserting ``54 months''.
(B) Effective on October 1, 2014, subclause (IV) of
section 505(j)(5)(D)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)), as amended by
subparagraph (A), is amended by striking ``54 months''
and inserting ``48 months''.
(C) Effective on October 1, 2015, subclause (IV) of
section 505(j)(5)(D)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)), as amended by
subparagraph (B), is amended by striking ``48 months''
and inserting ``42 months''.
(D) Effective on October 1, 2016, subclause (IV) of
section 505(j)(5)(D)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)), as amended by
subparagraph (C), is amended by striking ``42 months''
and inserting ``36 months''.
(E) Effective on October 1, 2017, subclause (IV) of
section 505(j)(5)(D)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)), as amended by
subparagraph (D), is amended by striking ``36 months''
and inserting ``30 months''.
(2) Applicability.--
(A) The amendments made by subparagraphs (A), (B),
(C), and (D) of paragraph (1) apply only with respect
to an application under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that--
(i) is filed and initially contains a
certification described in paragraph
(2)(A)(vii)(IV) during the period of one fiscal
year beginning on the effective date of the
respective amendment; or
(ii) is amended to initially contain such a
certification during such period.
(B) The amendment made by paragraph (1)(E) applies
only with respect to an application under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) that--
(i) is filed and initially contains a
certification described in paragraph
(2)(A)(vii)(IV) on or after October 1, 2017; or
(ii) is amended to initially contain such a
certification on or after October 1, 2017.
(c) Conforming Amendment.--Subparagraph (G) of section 505(q)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) is
amended by striking ``the 30-month period'' and inserting ``the
period''.
SEC. 3. MAINTENANCE OF OFFICE OF GENERIC DRUGS AT CDER; REPORTING.
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:
``(11) Office of generic drugs.--
``(A) Office.--The Secretary shall maintain the
Office of Generic Drugs as a separate office within the
Center for Drug Evaluation and Research of the Food and
Drug Administration.
``(B) Reporting.--The Director of the Office of
Generic Drugs shall report directly to the Director of
the Center for Drug Evaluation and Research.''.
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