II 

Calendar No. 107 

118TH CONGRESS 

1ST SESSION S. 1067 

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

petitions. 

IN THE SENATE OF THE UNITED STATES 

MARCH 29, 2023 

Mrs. SHAHEEN (for herself, Ms. COLLINS, Mr. BENNET, Mr. RUBIO, Ms. 

BALDWIN, 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 citizen petitions. 

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 ‘‘Ensuring Timely Ac5 cess to Generics Act of 2023’’. 


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1 SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 

2 Section 505(q) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355(q)) is amended— 

4 (1) in paragraph (1)— 

5 (A) in subparagraph (A)(i), by inserting ‘‘, 

6 10.31,’’ after ‘‘10.30’’; 

7 (B) in subparagraph (E)— 

8 (i) by striking ‘‘application and’’ and 

9 inserting ‘‘application or’’; 

10 (ii) by striking ‘‘If the Secretary’’ and 

11 inserting the following: 

12 ‘‘(i) IN GENERAL.—If the Secretary’’; 

13 (iii) by striking the second sentence 

14 and inserting the following: 

15 ‘‘(ii) PRIMARY PURPOSE OF DELAY16 ING.— 

17 ‘‘(I) IN GENERAL.—In deter18 mining whether a petition was sub19 mitted with the primary purpose of 

20 delaying an application, the Secretary 

21 may consider the following factors: 

22 ‘‘(aa) Whether the petition 

23 was submitted in accordance with 

24 paragraph (2)(B), based on when 

25 the petitioner knew or reasonably 

26 should have known the relevant 


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1 information relied upon to form 

2 the basis of such petition. 

3 ‘‘(bb) Whether the petitioner 

4 has submitted multiple or serial 

5 petitions or supplements to peti6 tions raising issues that reason7 ably could have been known to 

8 the petitioner at the time of sub9 mission of the earlier petition or 

10 petitions. 

11 ‘‘(cc) Whether the petition 

12 was submitted close in time to a 

13 known, first date upon which an 

14 application under subsection 

15 (b)(2) or (j) of this section or 

16 section 351(k) of the Public 

17 Health Service Act could be ap18 proved. 

19 ‘‘(dd) Whether the petition 

20 was submitted without relevant 

21 data or information in support of 

22 the scientific positions forming 

23 the basis of such petition. 

24 ‘‘(ee) Whether the petition 

25 raises the same or substantially 


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1 similar issues as a prior petition 

2 to which the Secretary has re3 sponded substantively already, in4 cluding if the subsequent submis5 sion follows such response from 

6 the Secretary closely in time. 

7 ‘‘(ff) Whether the petition 

8 requests changing the applicable 

9 standards that other applicants 

10 are required to meet, including 

11 requesting testing, data, or label12 ing standards that are more on13 erous or rigorous than the stand14 ards the Secretary has deter15 mined to be applicable to the list16 ed drug, reference product, or pe17 titioner’s version of the same 

18 drug. 

19 ‘‘(gg) The petitioner’s record 

20 of submitting petitions to the 

21 Food and Drug Administration 

22 that have been determined by the 

23 Secretary to have been submitted 

24 with the primary purpose of 

25 delay. 


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1 ‘‘(hh) Other relevant and 

2 appropriate factors, which the 

3 Secretary shall describe in guid4 ance. 

5 ‘‘(II) GUIDANCE.—The Secretary 

6 may issue or update guidance, as ap7 propriate, to describe factors the Sec8 retary considers in accordance with 

9 subclause (I).’’; and 

10 (iv) by adding at the end the fol11 lowing: 

12 ‘‘(iii) REFERRAL TO THE FEDERAL

13 TRADE COMMISSION.—The Secretary shall 

14 establish procedures for referring to the 

15 Federal Trade Commission any petition or 

16 supplement to a petition that the Secretary 

17 determines was submitted with the primary 

18 purpose of delaying approval of an applica19 tion. Such procedures shall include notifi20 cation to the petitioner by the Secretary.’’; 

21 (C) by striking subparagraph (F); 

22 (D) by redesignating subparagraphs (G) 

23 through (I) as subparagraphs (F) through (H), 

24 respectively; and 


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1 (E) in subparagraph (H), as so redesig2 nated, by striking ‘‘submission of this petition’’ 

3 and inserting ‘‘submission of this document’’; 

4 (2) in paragraph (2)— 

5 (A) by redesignating subparagraphs (A) 

6 through (C) as subparagraphs (C) through (E), 

7 respectively; 

8 (B) by inserting before subparagraph (C), 

9 as so redesignated, the following: 

10 ‘‘(A) IN GENERAL.—A person shall submit 

11 a petition to the Secretary under paragraph (1) 

12 before filing a civil action in which the person 

13 seeks to set aside, delay, rescind, withdraw, or 

14 prevent submission, review, or approval of an 

15 application submitted under subsection (b)(2) 

16 or (j) of this section or section 351(k) of the 

17 Public Health Service Act. Such petition and 

18 any supplement to such a petition shall describe 

19 all information and arguments that form the 

20 basis of the relief requested in any civil action 

21 described in the previous sentence. 

22 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PE23 TITION.—A petition and any supplement to a 

24 petition shall be submitted within 60 days after 

25 the person knew, or reasonably should have 


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1 known, the information that forms the basis of 

2 the request made in the petition or supple3 ment.’’; 

4 (C) in subparagraph (C), as so redesig5 nated— 

6 (i) in the heading, by striking ‘‘WITH7 IN 150 DAYS’’; 

8 (ii) in clause (i), by striking ‘‘during 

9 the 150-day period referred to in para10 graph (1)(F),’’; and 

11 (iii) by amending clause (ii) to read as 

12 follows: 

13 ‘‘(ii) on or after the date that is 151 

14 days after the date of submission of the 

15 petition, the Secretary approves or has ap16 proved the application that is the subject 

17 of the petition without having made such a 

18 final decision.’’; 

19 (D) by amending subparagraph (D), as so 

20 redesignated, to read as follows: 

21 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC22 TIONS.— 

23 ‘‘(i) PETITION.—If a person files a 

24 civil action against the Secretary in which 

25 a person seeks to set aside, delay, rescind, 


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1 withdraw, or prevent submission, review, or 

2 approval of an application submitted under 

3 subsection (b)(2) or (j) of this section or 

4 section 351(k) of the Public Health Service 

5 Act without complying with the require6 ments of subparagraph (A), the court shall 

7 dismiss without prejudice the action for 

8 failure to exhaust administrative remedies. 

9 ‘‘(ii) TIMELINESS.—If a person files a 

10 civil action against the Secretary in which 

11 a person seeks to set aside, delay, rescind, 

12 withdraw, or prevent submission, review, or 

13 approval of an application submitted under 

14 subsection (b)(2) or (j) of this section or 

15 section 351(k) of the Public Health Service 

16 Act without complying with the require17 ments of subparagraph (B), the court shall 

18 dismiss with prejudice the action for fail19 ure to timely file a petition. 

20 ‘‘(iii) FINAL RESPONSE.—If a civil ac21 tion is filed against the Secretary with re22 spect to any issue raised in a petition time23 ly filed under paragraph (1) in which the 

24 petitioner requests that the Secretary take 

25 any form of action that could, if taken, set 


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1 aside, delay, rescind, withdraw, or prevent 

2 submission, review, or approval of an appli3 cation submitted under subsection (b)(2) 

4 or (j) of this section or section 351(k) of 

5 the Public Health Service Act before the 

6 Secretary has taken final agency action on 

7 the petition within the meaning of sub8 paragraph (C), the court shall dismiss 

9 without prejudice the action for failure to 

10 exhaust administrative remedies.’’; and 

11 (E) in clause (iii) of subparagraph (E), as 

12 so redesignated, by striking ‘‘as defined under 

13 subparagraph (2)(A)’’ and inserting ‘‘within the 

14 meaning of subparagraph (C)’’; and 

15 (3) in paragraph (4)— 

16 (A) by striking ‘‘EXCEPTIONS’’ in the 

17 paragraph heading and all that follows through 

18 ‘‘This subsection does’’ and inserting ‘‘EXCEP19 TIONS.—This subsection does’’; 

20 (B) by striking subparagraph (B); and 

21 (C) by redesignating clauses (i) and (ii) as 

22 subparagraphs (A) and (B), respectively, and 

23 adjusting the margins accordingly. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ensuring Timely Access 

3 to Generics Act of 2023’’. 

4 SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 

5 Section 505(q) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355(q)) is amended— 

7 (1) in paragraph (1)— 

8 (A) in subparagraph (A)(i), by inserting ‘‘, 

9 10.31,’’ after ‘‘10.30’’; 

10 (B) in subparagraph (E)— 

11 (i) by striking ‘‘application and’’ and 

12 inserting ‘‘application or’’; 

13 (ii) by striking ‘‘If the Secretary’’ and 

14 inserting the following: 

15 ‘‘(i) IN GENERAL.—If the Secretary’’; 

16 and 

17 (iii) by striking the second sentence 

18 and inserting the following: 

19 ‘‘(ii) PRIMARY PURPOSE OF DELAY20 ING.— 

21 ‘‘(I) IN GENERAL.—In deter22 mining whether a petition was sub23 mitted with the primary purpose of de24 laying an application, the Secretary 

25 may consider the following factors: 


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1 ‘‘(aa) Whether the petition 

2 was submitted in accordance with 

3 paragraph (2)(B), based on when 

4 the petitioner knew the relevant 

5 information relied upon to form 

6 the basis of such petition. 

7 ‘‘(bb) When the petition was 

8 submitted in relation to when the 

9 petitioner reasonably should have 

10 known the relevant information 

11 relied upon to form the basis of 

12 such petition. 

13 ‘‘(cc) Whether the petitioner 

14 has submitted multiple or serial 

15 petitions or supplements to peti16 tions raising issues that reason17 ably could have been known to the 

18 petitioner at the time of submis19 sion of the earlier petition or peti20 tions. 

21 ‘‘(dd) Whether the petition 

22 was submitted close in time to a 

23 known, first date upon which an 

24 application under subsection 

25 (b)(2) or (j) of this section or secVerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\S1067.RS S1067

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1 tion 351(k) of the Public Health 

2 Service Act could be approved. 

3 ‘‘(ee) Whether the petition 

4 was submitted without relevant 

5 data or information in support of 

6 the scientific positions forming the 

7 basis of such petition. 

8 ‘‘(ff) Whether the petition 

9 raises the same or substantially 

10 similar issues as a prior petition 

11 to which the Secretary has re12 sponded substantively already, in13 cluding if the subsequent submis14 sion follows such response from 

15 the Secretary closely in time. 

16 ‘‘(gg) Whether the petition 

17 requests changing the applicable 

18 standards that other applicants 

19 are required to meet, including re20 questing testing, data, or labeling 

21 standards that are more onerous 

22 or rigorous than the standards the 

23 Secretary has determined to be 

24 applicable to the listed drug, refVerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\S1067.RS S1067

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1 erence product, or petitioner’s 

2 version of the same drug. 

3 ‘‘(hh) The petitioner’s record 

4 of submitting petitions to the 

5 Food and Drug Administration 

6 that have been determined by the 

7 Secretary to have been submitted 

8 with the primary purpose of 

9 delay. 

10 ‘‘(ii) Other relevant and ap11 propriate factors, which the Sec12 retary shall describe in guidance. 

13 ‘‘(II) GUIDANCE.—The Secretary 

14 may issue or update guidance, as ap15 propriate, to describe factors the Sec16 retary considers in accordance with 

17 subclause (I).’’; 

18 (C) by striking subparagraph (F); 

19 (D) by redesignating subparagraphs (G) 

20 through (I) as subparagraphs (F) through (H), 

21 respectively; and 

22 (E) in subparagraph (H), as so redesig23 nated, by striking ‘‘submission of this petition’’ 

24 and inserting ‘‘submission of this document’’; 

25 (2) in paragraph (2)— 


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1 (A) by redesignating subparagraphs (A) 

2 through (C) as subparagraphs (C) through (E), 

3 respectively; 

4 (B) by inserting before subparagraph (C), 

5 as so redesignated, the following: 

6 ‘‘(A) IN GENERAL.—A person shall submit a 

7 petition to the Secretary under paragraph (1) 

8 before filing a civil action in which the person 

9 seeks to set aside, delay, rescind, withdraw, or 

10 prevent submission, review, or approval of an 

11 application submitted under subsection (b)(2) or 

12 (j) of this section or section 351(k) of the Public 

13 Health Service Act. Such petition and any sup14 plement to such a petition shall describe all in15 formation and arguments that form the basis of 

16 the relief requested in any civil action described 

17 in the previous sentence. 

18 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PETI19 TION.—A petition and any supplement to a peti20 tion shall be submitted within 180 days after the 

21 person knew the information that forms the basis 

22 of the request made in the petition or supple23 ment.’’; 

24 (C) in subparagraph (C), as so redesig25 nated— 


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1 (i) in the heading, by striking ‘‘WITHIN

2 150 DAYS’’; 

3 (ii) in clause (i), by striking ‘‘during 

4 the 150-day period referred to in paragraph 

5 (1)(F),’’; and 

6 (iii) by amending clause (ii) to read as 

7 follows: 

8 ‘‘(ii) on or after the date that is 151 

9 days after the date of submission of the peti10 tion, the Secretary approves or has ap11 proved the application that is the subject of 

12 the petition without having made such a 

13 final decision.’’; 

14 (D) by amending subparagraph (D), as so 

15 redesignated, to read as follows: 

16 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC17 TIONS.— 

18 ‘‘(i) PETITION.—If a person files a 

19 civil action against the Secretary in which 

20 a person seeks to set aside, delay, rescind, 

21 withdraw, or prevent submission, review, or 

22 approval of an application submitted under 

23 subsection (b)(2) or (j) of this section or sec24 tion 351(k) of the Public Health Service Act 

25 without complying with the requirements of 


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1 subparagraph (A), the court shall dismiss 

2 without prejudice the action for failure to 

3 exhaust administrative remedies. 

4 ‘‘(ii) TIMELINESS.—If a person files a 

5 civil action against the Secretary in which 

6 a person seeks to set aside, delay, rescind, 

7 withdraw, or prevent submission, review, or 

8 approval of an application submitted under 

9 subsection (b)(2) or (j) of this section or sec10 tion 351(k) of the Public Health Service Act 

11 without complying with the requirements of 

12 subparagraph (B), the court shall dismiss 

13 with prejudice the action for failure to time14 ly file a petition. 

15 ‘‘(iii) FINAL RESPONSE.—If a civil ac16 tion is filed against the Secretary with re17 spect to any issue raised in a petition time18 ly filed under paragraph (1) in which the 

19 petitioner requests that the Secretary take 

20 any form of action that could, if taken, set 

21 aside, delay, rescind, withdraw, or prevent 

22 submission, review, or approval of an appli23 cation submitted under subsection (b)(2) or 

24 (j) of this section or section 351(k) of the 

25 Public Health Service Act before the SecVerDate Sep 11 2014 00:12 Jun 23, 2023 Jkt 039200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6203 E:\BILLS\S1067.RS S1067

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1 retary has taken final agency action on the 

2 petition within the meaning of subpara3 graph (C), the court shall dismiss without 

4 prejudice the action for failure to exhaust 

5 administrative remedies.’’; and 

6 (E) in clause (iii) of subparagraph (E), as 

7 so redesignated, by striking ‘‘as defined under 

8 subparagraph (2)(A)’’ and inserting ‘‘within the 

9 meaning of subparagraph (C)’’; and 

10 (3) in paragraph (4)— 

11 (A) by striking ‘‘EXCEPTIONS’’ in the para12 graph heading and all that follows through ‘‘This 

13 subsection does’’ and inserting ‘‘EXCEPTIONS.— 

14 This subsection does’’; 

15 (B) by striking subparagraph (B); and 

16 (C) by redesignating clauses (i) and (ii) as 

17 subparagraphs (A) and (B), respectively, and 

18 adjusting the margins accordingly. 


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Calendar No. 107 

118TH CONGRESS 

1ST SESSION S. 1067 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

Act with respect to citizen petitions. 

JUNE 22, 2023 

Reported with an amendment 


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