II 

Calendar No. 108 

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 

JUNE 22, 2023 

Reported by Mr. SANDERS, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 


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1 SEC. 2. 180-DAY EXCLUSIVITY PERIOD. 

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

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

4 355(j)(5)(B)(iv)) is amended— 

5 (1) in subclause (I)— 

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

7 after ‘‘subparagraph (D)’’; and 

8 (B) by inserting before the period at the 

9 end the following: ‘‘or an applicant whose appli10 cation was approved pursuant to subclause 

11 (III). If an applicant described in subclause 

12 (III) is eligible for effective approval on the 

13 same day a tentatively approved first applicant 

14 who has requested final approval is determined 

15 by the Secretary to be eligible for effective ap16 proval by meeting all the approval requirements 

17 of this subsection, such applicant described in 

18 subclause (III) may not receive effective ap19 proval until 180 days after the first applicant 

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

21 (2) by adding at the end the following new sub22 clause: 

23 ‘‘(III) APPLICANT APPROVAL.—The Sec24 retary may approve an application containing a 

25 certification described in paragraph 

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


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1 first applicant has submitted an application 

2 containing such a certification, notwithstanding 

3 the eligibility of a first applicant for the 180- 

4 day exclusivity period described in subclause 

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

6 met: 

7 ‘‘(aa) The approval of such applica8 tion could be made effective, but for the 

9 eligibility of a first applicant for 180-day 

10 exclusivity under this clause. 

11 ‘‘(bb) The applicant of such applica12 tion has submitted a certification to the 

13 abbreviated new drug application that 

14 there are no conditions that would prevent 

15 the applicant from commercial marketing 

16 within 75 days after the date of approval 

17 and that the applicant intends to so mar18 ket the drug. 

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

20 since the date of submission of an applica21 tion for the drug by at least one first ap22 plicant. 

23 ‘‘(dd) Approval of an application for 

24 the drug submitted by at least one first ap25 plicant is not precluded under clause (iii). 


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1 ‘‘(ee) No application for the drug sub2 mitted by any first applicant is effectively 

3 approved on the date that the conditions 

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

5 all met and maintained.’’. 

6 (b) SPECIAL APPROVAL STATUS RULE FOR CERTAIN

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

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

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

10 ‘‘(v) SPECIAL APPROVAL STATUS RULE

11 FOR CERTAIN SUBSEQUENT APPLICANTS.—An 

12 application that is approved pursuant to sub13 clause (III) of subparagraph (B)(iv) is deemed 

14 to be tentatively approved and to no longer 

15 have an effective approval pursuant to such 

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

17 the date on which the approval has been made 

18 effective pursuant to such subclause (III) if the 

19 applicant fails to commercially market such 

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

21 which the approval is made effective. If the ap22 plicant of an application approved pursuant to 

23 such subclause (III) submits a notification that 

24 it can no longer commence commercial mar25 keting within 75 days after the date of apVerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S1114.RS S1114

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1 proval, as required under subparagraph 

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

3 tentatively approved and to no longer be effec4 tively approved on the date that such a notifica5 tion is received. If an applicant does not com6 mence commercial marketing within the 75-day 

7 period, it shall not be eligible for a subsequent 

8 effective approval for the application under sub9 clause (III) of subparagraph (B)(iv) unless, in 

10 addition to meeting each of the conditions in 

11 such subclause (III), it submits a certification 

12 to its abbreviated new drug application that an 

13 event that could not have been reasonably fore14 seen by the applicant prevented it from com15 mencing commercial marketing and that it has 

16 fully resolved this issue. The applicant shall 

17 submit notification to the abbreviated new drug 

18 application confirming that such applicant has 

19 commenced commercial marketing of the drug 

20 not later than one business day after com21 mencing such marketing.’’. 

22 (c) APPLICABILITY.—The amendments made by sub23 sections (a) and (b) shall apply only with respect to an 

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

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


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

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

3 such section 505(j) was made before such date of enact4 ment. 

5 SECTION 1. SHORT TITLE. 

6 This Act may be cited as the ‘‘Expanding Access to 

7 Low-Cost Generics Act of 2023’’. 

8 SEC. 2. 180-DAY EXCLUSIVITY PERIOD. 

9 (a) IN GENERAL.—Section 505(j)(5)(B)(iv) of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

11 355(j)(5)(B)(iv)) is amended— 

12 (1) in subclause (I)— 

13 (A) by inserting ‘‘and subclause (III)’’ after 

14 ‘‘subparagraph (D)’’; and 

15 (B) by inserting before the period at the end 

16 the following: ‘‘or an applicant whose applica17 tion was approved pursuant to subclause (III). 

18 If an applicant described in subclause (III) is el19 igible for effective approval on the same day a 

20 tentatively approved first applicant who has re21 quested final approval is determined by the Sec22 retary to be eligible for effective approval by 

23 meeting all the approval requirements of this 

24 subsection, such applicant described in subclause 

25 (III) shall not receive effective approval until 


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1 180 days after the first applicant begins com2 mercial marketing of the drug.’’; and 

3 (2) by adding at the end the following new sub4 clause: 

5 ‘‘(III) APPLICANT APPROVAL.—The Sec6 retary may approve an application containing a 

7 certification described in paragraph 

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

9 first applicant has submitted an application 

10 containing such a certification, notwithstanding 

11 the eligibility of a first applicant for the 180-day 

12 exclusivity period described in subclause 

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

14 met: 

15 ‘‘(aa) The approval of such application 

16 could be made effective, but for the eligibility of 

17 a first applicant for 180-day exclusivity under 

18 this clause. 

19 ‘‘(bb) The applicant of such application has 

20 submitted a certification to its abbreviated new 

21 drug application that there are no conditions 

22 that would prevent the applicant from commer23 cial marketing within 75 days after the date of 

24 approval and that the applicant intends to so 

25 market the drug. 


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1 ‘‘(cc) At least 33 months have passed since 

2 the date of submission of an application for the 

3 drug by at least one first applicant. 

4 ‘‘(dd) Approval of an application for the 

5 drug submitted by at least one first applicant is 

6 not precluded under clause (iii). 

7 ‘‘(ee) No application for the drug submitted 

8 by any first applicant is effectively approved on 

9 the date that the conditions under items (aa), 

10 (bb), (cc), and (dd) are all met and main11 tained.’’. 

12 (b) SPECIAL APPROVAL STATUS RULE FOR CERTAIN

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

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

15 355(j)(5)(D)) is amended at the end by adding the fol16 lowing: 

17 ‘‘(v) SPECIAL APPROVAL STATUS RULE

18 FOR CERTAIN SUBSEQUENT APPLICANTS.— 

19 An application that is approved pursuant 

20 to subclause (III) of subparagraph (B)(iv) 

21 is deemed to be tentatively approved and to 

22 no longer have an effective approval pursu23 ant to such subclause (III) on the date that 

24 is 76 days after the date on which the ap25 proval has been made effective pursuant to 


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1 such subclause (III) if the applicant fails to 

2 commercially market such drug within the 

3 75-day period after the date on which the 

4 approval is made effective. If the applicant 

5 of an application approved pursuant to 

6 such subclause (III) submits a notification 

7 that it can no longer commence commercial 

8 marketing within 75 days after the date of 

9 approval, as required under subparagraph 

10 (B)(iv)(III)(bb), its application is deemed 

11 to be tentatively approved and to no longer 

12 be effectively approved on the date that such 

13 a notification is received. If an applicant 

14 does not commence commercial marketing 

15 within the 75-day period, it shall not be eli16 gible for a subsequent effective approval for 

17 the application under subclause (III) of sub18 paragraph (B)(iv) unless, in addition to 

19 meeting each of the conditions in such sub20 clause (III), it submits a certification to its 

21 abbreviated new drug application that an 

22 event that could not have been reasonably 

23 foreseen by the applicant prevented it from 

24 commencing commercial marketing and 

25 that it has fully resolved this issue. The apVerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\S1114.RS S1114

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1 plicant shall submit notification to the ab2 breviated new drug application confirming 

3 that such applicant has commenced com4 mercial marketing of the drug not later 

5 than one business day after commencing 

6 such marketing.’’. 

7 (c) APPLICABILITY.—The amendments made by sub8 sections (a) and (b) shall apply only with respect to an 

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

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

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

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

13 such section 505(j) was made before such date of enactment. 

14 SEC. 3. INCREASING TRANSPARENCY IN GENERIC DRUG AP15 PLICATIONS. 

16 (a) IN GENERAL.—Section 505(j)(3) of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 

18 amended by adding at the end the following: 

19 ‘‘(H)(i) Upon request (in controlled correspondence or 

20 an analogous process) by a person that has submitted or 

21 intends to submit an abbreviated application under this 

22 subsection for a drug that is required by regulation to con23 tain one or more of the same inactive ingredients in the 

24 same concentration as the listed drug referred to, or for 

25 which the Secretary determines there is a scientific jusVerDate Sep 11 2014 00:13 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\S1114.RS S1114

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1 tification for an approach that is in vitro, in whole or in 

2 part, to be used to demonstrate bioequivalence for a drug 

3 if such a drug contains one or more of the same inactive 

4 ingredients in the same concentration as the listed drug re5 ferred to, or on the Secretary’s own initiative during the 

6 review of an application under this subsection for such a 

7 drug, the Secretary shall inform the person whether such 

8 drug is qualitatively and quantitatively the same as the 

9 listed drug. 

10 ‘‘(ii) Notwithstanding section 301(j), if the Secretary 

11 determines that such drug is not qualitatively or quan12 titatively the same as the listed drug, the Secretary shall 

13 identify and disclose to the person— 

14 ‘‘(I) the ingredient or ingredients that cause the 

15 drug not to be qualitatively or quantitatively the 

16 same as the listed drug; and 

17 ‘‘(II) for any ingredient for which there is an 

18 identified quantitative deviation, the amount of such 

19 deviation. 

20 ‘‘(iii) If the Secretary determines that such drug is 

21 qualitatively and quantitatively the same as the listed drug, 

22 the Secretary shall not change or rescind such determina23 tion after the submission of an abbreviated application for 

24 such drug under this subsection unless— 


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1 ‘‘(I) the formulation of the listed drug has been 

2 changed and the Secretary has determined that the 

3 prior listed drug formulation was withdrawn for rea4 sons of safety or effectiveness; or 

5 ‘‘(II) the Secretary makes a written determina6 tion that the prior determination must be changed be7 cause an error has been identified. 

8 ‘‘(iv) If the Secretary makes a written determination 

9 described in clause (iii)(II), the Secretary shall provide no10 tice and a copy of the written determination to the person 

11 making the request under clause (i). 

12 ‘‘(v) Except as set forth in clauses (i) and (ii), nothing 

13 in this subparagraph shall be construed to authorize the dis14 closure of nonpublic qualitative or quantitative information 

15 about the ingredients in a listed drug, or to affect the status, 

16 if any, of such information as trade secret or confidential 

17 commercial information for purposes of section 301(j) of 

18 this Act, section 552 of title 5, United States Code, or sec19 tion 1905 of title 18, United States Code.’’. 

20 (b) GUIDANCE.— 

21 (1) IN GENERAL.—Not later than one year after 

22 the date of enactment of this Act, the Secretary of 

23 Health and Human Services shall issue draft guid24 ance, or update guidance, describing how the Sec25 retary will determine whether a drug is qualitatively 


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1 and quantitatively the same as the listed drug (as 

2 such terms are used in section 505(j)(3)(H) of the 

3 Federal Food, Drug, and Cosmetic Act, as added by 

4 subsection (a)), including with respect to assessing 

5 pH adjusters. 

6 (2) PROCESS.—In issuing guidance under this 

7 subsection, the Secretary of Health and Human Serv8 ices shall— 

9 (A) publish draft guidance; 

10 (B) provide a period of at least 60 days for 

11 comment on the draft guidance; and 

12 (C) after considering any comments received 

13 and not later than one year after the close of the 

14 comment period on the draft guidance, publish 

15 final guidance. 

16 (c) APPLICABILITY.—Section 505(j)(3)(H) of the Fed17 eral Food, Drug, and Cosmetic Act, as added by subsection 

18 (a), applies beginning on the date of enactment of this Act, 

19 irrespective of the date on which the guidance required by 

20 subsection (b) is finalized. 


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Calendar No. 108 

118TH CONGRESS 

1ST SESSION S. 1114 

A BILL 

Act with respect to the 180-day exclusivity period. 

To amend the Federal Food, Drug, and Cosmetic 

JUNE 22, 2023 

Reported with an amendment 


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