I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Generic Drug Applica5 tion Review Fairness Act of 2012’’. 


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1 SEC. 2. EXTENSION OF PERIOD FOR FIRST APPLICANT TO 

2 OBTAIN TENTATIVE APPROVAL WITHOUT 

3 FORFEITING 180-DAY EXCLUSIVITY PERIOD. 

4 (a) EXTENSION OF PERIOD.— 

5 (1) IN GENERAL.—Subclause (IV) of section 

6 505(j)(5)(D)(i) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 355(j)(5)(D)(i)) is amended to 

8 read as follows: 

9 ‘‘(IV) FAILURE TO OBTAIN TEN10 TATIVE APPROVAL.—The first appli11 cant fails to obtain tentative approval 

12 of the application within 60 months 

13 after the date on which— 

14 ‘‘(aa) the application is filed 

15 and initially contains a certifi16 cation described in paragraph 

17 (2)(A)(vii)(IV), or 

18 ‘‘(bb) the application is 

19 amended to first contain such a 

20 certification, 

21 unless the failure is caused by a 

22 change in or a review of the require23 ments for approval of the application 

24 imposed after the date on which the 

25 application is so filed or amended.’’. 

26 (2) APPLICABILITY.— 


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1 (A) IN GENERAL.—Subject to subsection 

2 (b), the amendment made by paragraph (1) ap3 plies— 

4 (i) only with respect to an application 

5 that is filed under section 505(j) of the 

6 Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 355(j)) on or after the day that is 

8 30 months prior to the date of the enact9 ment of this Act; and 

10 (ii) only if no certification under para11 graph (2)(A)(vii)(IV) of such section 

12 505(j) was made before such day with re13 spect to the listed drug (as such term is 

14 used in such section 505(j)). 

15 (B) CERTAIN APPLICATIONS.—If an appli16 cation was filed under section 505(j) of the 

17 Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 355(j)) prior to the day specified in sub19 paragraph (A)(i) and, on such day, contained a 

20 certification described in paragraph 

21 (2)(A)(vii)(IV), the application shall be subject 

22 to paragraph (5)(D)(i)(IV) of such section 

23 505(j) as in effect on the day before the date 

24 of the enactment of this Act. 


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1 (b) INCREMENTAL REDUCTION OF EXTENDED PE2 RIOD.— 

3 (1) PERIOD DURATION.— 

4 (A) Effective on October 1, 2013, sub5 clause (IV) of section 505(j)(5)(D)(i) of the 

6 Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 355(j)(5)(D)(i)), as amended by sub8 section (a)(1), is amended by striking ‘‘60 

9 months’’ and inserting ‘‘54 months’’. 

10 (B) Effective on October 1, 2014, sub11 clause (IV) of section 505(j)(5)(D)(i) of the 

12 Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 355(j)(5)(D)(i)), as amended by sub14 paragraph (A), is amended by striking ‘‘54 

15 months’’ and inserting ‘‘48 months’’. 

16 (C) Effective on October 1, 2015, sub17 clause (IV) of section 505(j)(5)(D)(i) of the 

18 Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 355(j)(5)(D)(i)), as amended by sub20 paragraph (B), is amended by striking ‘‘48 

21 months’’ and inserting ‘‘42 months’’. 

22 (D) Effective on October 1, 2016, sub23 clause (IV) of section 505(j)(5)(D)(i) of the 

24 Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 355(j)(5)(D)(i)), as amended by subVerDate Mar 15 2010 23:24 Apr 05, 2012 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4332.IH H4332

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1 paragraph (C), is amended by striking ‘‘42 

2 months’’ and inserting ‘‘36 months’’. 

3 (E) Effective on October 1, 2017, sub4 clause (IV) of section 505(j)(5)(D)(i) of the 

5 Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 355(j)(5)(D)(i)), as amended by sub7 paragraph (D), is amended by striking ‘‘36 

8 months’’ and inserting ‘‘30 months’’. 

9 (2) APPLICABILITY.— 

10 (A) The amendments made by subpara11 graphs (A), (B), (C), and (D) of paragraph (1) 

12 apply only with respect to an application under 

13 section 505(j) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 355(j)) that— 

15 (i) is filed and initially contains a cer16 tification described in paragraph 

17 (2)(A)(vii)(IV) during the period of one 

18 fiscal year beginning on the effective date 

19 of the respective amendment; or 

20 (ii) is amended to initially contain 

21 such a certification during such period. 

22 (B) The amendment made by paragraph 

23 (1)(E) applies only with respect to an applica24 tion under section 505(j) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355(j)) 

2 that— 

3 (i) is filed and initially contains a cer4 tification described in paragraph 

5 (2)(A)(vii)(IV) on or after October 1, 

6 2017; or 

7 (ii) is amended to initially contain 

8 such a certification on or after October 1, 

9 2017. 

10 (c) CONFORMING AMENDMENT.—Subparagraph (G) 

11 of section 505(q)(1) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 355(q)(1)) is amended by striking 

13 ‘‘the 30-month period’’ and inserting ‘‘the period’’. 

14 SEC. 3. MAINTENANCE OF OFFICE OF GENERIC DRUGS AT 

15 CDER; REPORTING. 

16 Section 505(j) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

18 end the following: 

19 ‘‘(11) OFFICE OF GENERIC DRUGS.— 

20 ‘‘(A) OFFICE.—The Secretary shall main21 tain the Office of Generic Drugs as a separate 

22 office within the Center for Drug Evaluation 

23 and Research of the Food and Drug Adminis24 tration. 


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1 ‘‘(B) REPORTING.—The Director of the 

2 Office of Generic Drugs shall report directly to 

3 the Director of the Center for Drug Evaluation 

4 and Research.’’. 

Æ 


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