I 112th CONGRESS 2d Session H. R. 4332 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.

1.

Short title

This Act may be cited as the Generic Drug Application Review Fairness Act of 2012.

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.

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. .