II 

118TH CONGRESS 

1ST SESSION S. 1114 

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

180-day exclusivity period. 

IN THE SENATE OF THE UNITED STATES 

MARCH 30, 2023 

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. 

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 2023’’. 

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— 

10 (1) in subclause (I)— 


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1 (A) by inserting ‘‘and subclause (III)’’ 

2 after ‘‘subparagraph (D)’’; and 

3 (B) by inserting before the period at the 

4 end the following: ‘‘or an applicant whose appli5 cation was approved pursuant to subclause 

6 (III). If an applicant described in subclause 

7 (III) is eligible for effective approval on the 

8 same day a tentatively approved first applicant 

9 who has requested final approval is determined 

10 by the Secretary to be eligible for effective ap11 proval by meeting all the approval requirements 

12 of this subsection, such applicant described in 

13 subclause (III) may not receive effective ap14 proval until 180 days after the first applicant 

15 begins commercial marketing of the drug.’’; and 

16 (2) by adding at the end the following new sub17 clause: 

18 ‘‘(III) APPLICANT APPROVAL.—The Sec19 retary may approve an application containing a 

20 certification described in paragraph 

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

22 first applicant has submitted an application 

23 containing such a certification, notwithstanding 

24 the eligibility of a first applicant for the 180- 

25 day exclusivity period described in subclause 


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

2 met: 

3 ‘‘(aa) The approval of such applica4 tion could be made effective, but for the 

5 eligibility of a first applicant for 180-day 

6 exclusivity under this clause. 

7 ‘‘(bb) The applicant of such applica8 tion has submitted a certification to the 

9 abbreviated new drug application that 

10 there are no conditions that would prevent 

11 the applicant from commercial marketing 

12 within 75 days after the date of approval 

13 and that the applicant intends to so mar14 ket the drug. 

15 ‘‘(cc) At least 33 months have passed 

16 since the date of submission of an applica17 tion for the drug by at least one first ap18 plicant. 

19 ‘‘(dd) Approval of an application for 

20 the drug submitted by at least one first ap21 plicant is not precluded under clause (iii). 

22 ‘‘(ee) No application for the drug sub23 mitted by any first applicant is effectively 

24 approved on the date that the conditions 


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1 under items (aa), (bb), (cc), and (dd) are 

2 all met and maintained.’’. 

3 (b) SPECIAL APPROVAL STATUS RULE FOR CERTAIN

4 SUBSEQUENT APPLICANTS.—Section 505(j)(5)(D) of the 

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 

6 (j)(5)(D)) is amended at the end by adding the following: 

7 ‘‘(v) SPECIAL APPROVAL STATUS RULE

8 FOR CERTAIN SUBSEQUENT APPLICANTS.—An 

9 application that is approved pursuant to sub10 clause (III) of subparagraph (B)(iv) is deemed 

11 to be tentatively approved and to no longer 

12 have an effective approval pursuant to such 

13 subclause (III) on the date that is 76 days after 

14 the date on which the approval has been made 

15 effective pursuant to such subclause (III) if the 

16 applicant fails to commercially market such 

17 drug within the 75-day period after the date on 

18 which the approval is made effective. If the ap19 plicant of an application approved pursuant to 

20 such subclause (III) submits a notification that 

21 it can no longer commence commercial mar22 keting within 75 days after the date of ap23 proval, as required under subparagraph 

24 (B)(iv)(III)(bb), its application is deemed to be 

25 tentatively approved and to no longer be effecVerDate Sep 11 2014 06:08 Apr 11, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1114.IS S1114

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1 tively approved on the date that such a notifica2 tion is received. If an applicant does not com3 mence commercial marketing within the 75-day 

4 period, it shall not be eligible for a subsequent 

5 effective approval for the application under sub6 clause (III) of subparagraph (B)(iv) unless, in 

7 addition to meeting each of the conditions in 

8 such subclause (III), it submits a certification 

9 to its abbreviated new drug application that an 

10 event that could not have been reasonably fore11 seen by the applicant prevented it from com12 mencing commercial marketing and that it has 

13 fully resolved this issue. The applicant shall 

14 submit notification to the abbreviated new drug 

15 application confirming that such applicant has 

16 commenced commercial marketing of the drug 

17 not later than one business day after com18 mencing such marketing.’’. 

19 (c) APPLICABILITY.—The amendments made by sub20 sections (a) and (b) shall apply only with respect to an 

21 application filed under section 505(j) of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date 

23 of enactment of this Act that identifies a listed drug for 

24 which no certification under paragraph (2)(A)(vii)(IV) of 


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1 such section 505(j) was made before such date of enact2 ment. 

Æ 


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