II 

114TH CONGRESS 

2D SESSION S. 3387 

To provide for the fast track review of certain generic drugs. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 22, 2016 

Mr. COTTON introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the fast track review of certain generic drugs. 

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 ‘‘Safely Advancing Valu5 able and Inexpensive New Generic Solutions Act’’ or the 

6 ‘‘SAVINGS Act’’. 

7 SEC. 2. FAST TRACK REVIEW FOR CERTAIN GENERIC 

8 DRUGS. 

9 Section 505(j) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

11 end the following: 


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1 ‘‘(11)(A) Notwithstanding any other provision 

2 of law, the Secretary shall prioritize the review of a 

3 qualifying application under this subsection and 

4 shall, within 150 days of the initial receipt of such 

5 qualifying application, take final agency action on 

6 the application. 

7 ‘‘(B) For purposes of this paragraph, the term 

8 ‘qualifying application’ means an application— 

9 ‘‘(i) that does not contain a certification 

10 under subclause (IV) of paragraph (2)(A)(vii); 

11 ‘‘(ii) that may contain a certification under 

12 subclause (III) of paragraph (2)(A)(vii) only if 

13 such certification asserts that an existing pat14 ent will expire not more than 5 months after 

15 the date of such certification; 

16 ‘‘(iii) for a drug where the reference drug 

17 is a drug for which there is no exclusivity pe18 riod in effect, including an exclusivity period 

19 under paragraph (5)(F), or under section 505A, 

20 section 527, or section 505E; and 

21 ‘‘(iv) for a drug where the reference drug 

22 has not been the reference drug for more than 

23 one other drug that— 

24 ‘‘(I) is approved under this sub25 section; and 


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1 ‘‘(II) has been introduced into inter2 state commerce in the 3-month period pre3 ceding the date of the qualifying applica4 tion. 

5 ‘‘(C) Notwithstanding any other provision of 

6 this paragraph and regardless of the date of submis7 sion, a qualifying application shall lose status as an 

8 application for priority review, and the Secretary’s 

9 timeline for taking action on such an application de10 scribed in subparagraph (A) shall no longer apply, 

11 if the application no longer meets the definition of 

12 a qualifying application.’’. 

13 SEC. 3. TRANSPARENCY. 

14 (a) IN GENERAL.—Not later than 6 months after en15 actment and every 6 months thereafter, the Secretary of 

16 Health and Human Services, acting through the Commis17 sioner of Food and Drugs, shall submit a report to the 

18 Committee on Health, Education, Labor, and Pensions of 

19 the Senate and the Committee on Energy and Commerce 

20 of the House of Representatives containing the informa21 tion described in subsection (c). 

22 (b) DEFINITION.—In this section the term ‘‘generic 

23 fast track review’’ means review under paragraph (11) of 

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

25 Act (21 U.S.C. 355(j)), as added by section 2 of this Act. 


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1 (c) CONTENTS OF REPORT.—The report described in 

2 subsection (a) shall include the following information: 

3 (1) The number of applications in the most re4 cent 6-month period that are subject to generic fast 

5 track review, and which of those applications— 

6 (A) are for a drug where the reference 

7 drug has not been the reference drug for any 

8 other application that is approved under sub9 section (j) of section 505 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 355); 

11 (B) are for a drug where the reference 

12 drug has been the reference drug for not more 

13 than one other application that is approved 

14 under subsection (j) of such section; and 

15 (C) are for a drug that is on the drug 

16 shortage list established under section 506E of 

17 the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 356e). 

19 (2) The average and median time before an ap20 plicant receives an approval decision for an applica21 tion subject to generic fast track review. 

22 (3) The number of applications subject to ge23 neric fast track review that were approved. 


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1 (4) At the time such report is submitted, the 

2 number of applications subject to fast track re3 view— 

4 (A) that have been withdrawn by the appli5 cant; 

6 (B) that have been granted tentative ap7 proval; 

8 (C) with respect to which the Food and 

9 Drug Administration has requested additional 

10 information from the sponsor of the application; 

11 (D) that are awaiting review by the Food 

12 and Drug Administration after additional infor13 mation has been supplied, as described in sub14 paragraph (C); and 

15 (E) with respect to which the Food and 

16 Drug Administration has recorded reception of 

17 the application but has yet to contact the spon18 sor regarding the status of the application. 

19 (5) A prediction of how long the Food and 

20 Drug Administration will take to respond to such 

21 applications that are awaiting review with either an 

22 approval or a rejection, and how many of such appli23 cations are expected to be withdrawn by the appli24 cant. 


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1 (6) The average review time for such applica2 tions that are receiving generic fast track review 

3 versus the standard review period. 

4 (7) The information described in paragraphs 

5 (1) through (6) with respect to applications for 

6 drugs under section 505 of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 355) that are subject 

8 to another form of priority review or fast-track re9 view. 

10 (8) An annual accounting of how the Food and 

11 Drug Administration has spent the fees it has re12 ceived under part 7 of subchapter C of chapter VII 

13 of such Act (21 U.S.C. 379f et seq.) to include the 

14 proportion of such fees that such Administration has 

15 spent on personnel costs. 

Æ 


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