II 

114TH CONGRESS 

2D SESSION S. 3466 

To allow sponsors of certain new drug applications to rely upon investigations 

conducted in certain foreign countries, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 29, 2016 

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

the Committee on Health, Education, Labor, and Pensions 

A BILL 

To allow sponsors of certain new drug applications to rely 

upon investigations conducted in certain foreign countries, 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 ‘‘Accelerating New 

5 Pharmaceutical Competition Act’’. 

6 SEC. 2. DRUGS APPROVED IN CERTAIN FOREIGN COUN7 TRIES. 

8 Section 505 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 355) is amended— 


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1 (1) in subsection (b), by adding at the end the 

2 following: 

3 ‘‘(7) An application described in paragraph (2) may 

4 rely upon investigations conducted in a country listed 

5 under subparagraph (A) or designated under subpara6 graph (B) of section 802(b)(1), including premarket clin7 ical and nonclinical investigations and postmarket surveil8 lance studies, if the drug that is the subject of such appli9 cation has been approved in such country.’’; and 

10 (2) in subsection (c)— 

11 (A) in paragraph (1), by striking ‘‘Within’’ 

12 and inserting ‘‘Except as provided in paragraph 

13 (5), within’’; and 

14 (B) by adding at the end the following: 

15 ‘‘(5) In the case of an application that relies on inves16 tigations conducted in a foreign country, as described in 

17 subsection (b)(7), within 90 days after the filing of such 

18 application under subsection (b), the Secretary shall ap19 prove the application if the Secretary finds that none of 

20 the grounds for denying approval specified in subsection 

21 (d) applies or take action described in paragraph (1)(B). 

22 If the Secretary does not approve the application or take 

23 such other action within such 90-day period, the applica24 tion shall be considered approved under this subsection.’’. 


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1 SEC. 3. APPROVAL OF GENERIC DRUGS. 

2 (a) STAYS IN THE CASE IF PATENT INFRINGEMENT

3 LAWSUITS.—Section 505(j)(5)(B)(iii) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 

5 355(j)(5)(B)(iii)) is amended by striking ‘‘the expiration 

6 of the thirty-month period beginning on the date of the 

7 receipt of the notice provided under paragraph (2)(B)(i)’’ 

8 and inserting ‘‘the date upon final judgment is entered 

9 in such action’’. 

10 (b) EXPEDITED GENERIC REVIEW.—Section 

11 505(j)(5) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 355(j)(5)) is amended— 

13 (1) in subparagraph (A), by striking ‘‘Within’’ 

14 and inserting ‘‘Except as provided in subparagraph 

15 (G), within’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(G)(i) The Secretary shall prioritize the review, and 

18 act not later than 150 calendar days after the date of the 

19 submission of an application, or supplement to an applica20 tion, in the case of an application or supplement to an 

21 application described in clause (ii). 

22 ‘‘(ii) Clause (i) shall apply to an application or sup23 plement to an application under this subsection with re24 spect to which the applicable listed drug, or another drug 

25 approved under this subsection with reference to such list26 ed drug— 


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1 ‘‘(I) has been introduced into interstate com2 merce by not more than one manufacturer or spon3 sor in the 3-month period immediately preceding the 

4 date of submission of such application or supplement 

5 and with respect to which tentative approval has 

6 been granted for not more than 2 applications under 

7 this subsection; or 

8 ‘‘(II) has been included on the drug shortage 

9 list under section 506E.’’. 

Æ 


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