[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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