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117TH CONGRESS 

1ST SESSION S. 2910 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

180-day exclusivity period, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 30, 2021 

Ms. SMITH (for herself and Mr. BRAUN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to 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 ‘‘Expanding Access to 

5 Low-Cost Generics Act of 2021’’. 

6 SEC. 2. 180-DAY EXCLUSIVITY PERIOD. 

7 (a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the 

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

9 355(j)(5)(B)(iv)) is amended— 


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S 2910 IS1S 

1 (1) in subclause (I), by inserting before the pe2 riod at the end the following: ‘‘or an applicant whose 

3 application was approved pursuant to subclause 

4 (III). If an applicant described in subclause (III) is 

5 eligible for effective approval on the same day a ten6 tatively approved first applicant who has requested 

7 final approval is determined by the Secretary to be 

8 eligible for effective approval by meeting all the ap9 proval requirements of this subsection, such appli10 cant may not receive effective approval until 180 

11 days after the first applicant begins commercial 

12 marketing of the drug.’’; and 

13 (2) by adding at the end the following new sub14 clause: 

15 ‘‘(III) APPLICANT APPROVAL.—The Sec16 retary may approve an application containing a 

17 certification described in paragraph 

18 (2)(A)(vii)(IV) that is for a drug for which a 

19 first applicant has submitted an application 

20 containing such a certification, notwithstanding 

21 the eligibility of a first applicant for the 180- 

22 day exclusivity period described in subclause 

23 (II)(aa), if each of the following conditions is 

24 met: 


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1 ‘‘(aa) The approval of such applica2 tion could be made effective, but for the 

3 eligibility of a first applicant for 180-day 

4 exclusivity under this clause. 

5 ‘‘(bb) At least 30 months have passed 

6 since the date of submission of an applica7 tion for the drug by at least one first ap8 plicant. 

9 ‘‘(cc) Approval of an application for 

10 the drug submitted by at least one first ap11 plicant is not precluded under clause (iii). 

12 ‘‘(dd) No application for the drug 

13 submitted by any first applicant is effec14 tively approved on the date that the condi15 tions under items (aa), (bb), and (cc) are 

16 all met, regardless of whether such applica17 tion is subsequently approved.’’. 

18 (b) APPLICABILITY.—The amendments made by sub19 section (a) shall apply only with respect to an application 

20 filed under section 505(j) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355(j)) after the date of enact22 ment of this Act that identifies a listed drug for which 

23 no certification under paragraph (2)(A)(vii)(IV) of such 

24 section was made before such date of enactment. 

Æ 


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