II 

117TH CONGRESS 

1ST SESSION S. 562 

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

petitions. 

IN THE SENATE OF THE UNITED STATES 

MARCH 3, 2021 

Mrs. SHAHEEN (for herself, Mr. CASSIDY, Mr. BENNET, and Mr. RUBIO) 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 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 2021’’. 

6 SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 

7 Section 505(q) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355(q)) is amended— 

9 (1) in paragraph (1)— 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•S 562 IS

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

2 10.31,’’ after ‘‘10.30’’; 

3 (B) in subparagraph (E)— 

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

5 inserting ‘‘application or’’; 

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

7 inserting the following: 

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

9 and 

10 (iii) by striking the second sentence 

11 and inserting the following: 

12 ‘‘(ii) PRIMARY PURPOSE OF DELAY13 ING.— 

14 ‘‘(I) IN GENERAL.—In deter15 mining whether a petition was sub16 mitted with the primary purpose of 

17 delaying an application, the Secretary 

18 may consider the following factors: 

19 ‘‘(aa) Whether the petition 

20 was submitted in accordance with 

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

22 the petitioner knew or reasonably 

23 should have known the relevant 

24 information relied upon to form 

25 the basis of such petition. 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•S 562 IS

1 ‘‘(bb) Whether the petitioner 

2 has submitted multiple or serial 

3 petitions or supplements to peti4 tions raising issues that reason5 ably could have been known to 

6 the petitioner at the time of sub7 mission of the earlier petition or 

8 petitions. 

9 ‘‘(cc) Whether the petition 

10 was submitted close in time to a 

11 known, first date upon which an 

12 application under subsection 

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

14 section 351(k) of the Public 

15 Health Service Act could be ap16 proved. 

17 ‘‘(dd) Whether the petition 

18 was submitted without relevant 

19 data or information in support of 

20 the scientific positions forming 

21 the basis of such petition. 

22 ‘‘(ee) Whether the petition 

23 raises the same or substantially 

24 similar issues as a prior petition 

25 to which the Secretary has reVerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562

pbinns on DSKJLVW7X2PROD with BILLS
4 

•S 562 IS

1 sponded substantively already, in2 cluding if the subsequent submis3 sion follows such response from 

4 the Secretary closely in time. 

5 ‘‘(ff) Whether the petition 

6 requests changing the applicable 

7 standards that other applicants 

8 are required to meet, including 

9 requesting testing, data, or label10 ing standards that are more on11 erous or rigorous than the stand12 ards the Secretary has deter13 mined to be applicable to the list14 ed drug, reference product, or pe15 titioner’s version of the same 

16 drug. 

17 ‘‘(gg) The petitioner’s record 

18 of submitting petitions to the 

19 Food and Drug Administration 

20 that have been determined by the 

21 Secretary to have been submitted 

22 with the primary purpose of 

23 delay. 

24 ‘‘(hh) Other relevant and 

25 appropriate factors, which the 


pbinns on DSKJLVW7X2PROD with BILLS
5 

•S 562 IS

1 Secretary shall describe in guid2 ance. 

3 ‘‘(II) GUIDANCE.—The Secretary 

4 may issue or update guidance, as ap5 propriate, to describe factors the Sec6 retary considers in accordance with 

7 subclause (I).’’; 

8 (C) by adding at the end the following: 

9 ‘‘(iii) REFERRAL TO THE FEDERAL

10 TRADE COMMISSION.—The Secretary shall 

11 establish procedures for referring to the 

12 Federal Trade Commission any petition or 

13 supplement to a petition that the Secretary 

14 determines was submitted with the primary 

15 purpose of delaying approval of an applica16 tion. Such procedures shall include notifi17 cation to the petitioner by the Secretary.’’; 

18 (D) by striking subparagraph (F); 

19 (E) by redesignating subparagraphs (G) 

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

21 respectively; and 

22 (F) 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)— 


pbinns on DSKJLVW7X2PROD with BILLS
6 

•S 562 IS

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 

7 a 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) 

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

13 Public Health Service Act. Such petition and 

14 any supplement to such a petition shall describe 

15 all information and arguments that form the 

16 basis of the relief requested in any civil action 

17 described in the previous sentence. 

18 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PE19 TITION.—A petition and any supplement to a 

20 petition shall be submitted within 60 days after 

21 the person knew, or reasonably should have 

22 known, the information that forms the basis of 

23 the request made in the petition or supple24 ment.’’; 


pbinns on DSKJLVW7X2PROD with BILLS
7 

•S 562 IS

1 (C) in subparagraph (C), as so redesig2 nated— 

3 (i) in the heading, by striking ‘‘WITH4 IN 150 DAYS’’; 

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

6 the 150-day period referred to in para7 graph (1)(F),’’; and 

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

9 follows: 

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

11 days after the date of submission of the 

12 petition, the Secretary approves or has ap13 proved the application that is the subject 

14 of the petition without having made such a 

15 final decision.’’; 

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

17 redesignated, to read as follows: 

18 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC19 TIONS.— 

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

21 civil action against the Secretary in which 

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

23 withdraw, or prevent submission, review, or 

24 approval of an application submitted under 

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


pbinns on DSKJLVW7X2PROD with BILLS
8 

•S 562 IS

1 section 351(k) of the Public Health Service 

2 Act without complying with the require3 ments of subparagraph (A), the court shall 

4 dismiss without prejudice the action for 

5 failure to exhaust administrative remedies. 

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

7 civil action against the Secretary in which 

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

9 withdraw, or prevent submission, review, or 

10 approval of an application submitted under 

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

12 section 351(k) of the Public Health Service 

13 Act without complying with the require14 ments of subparagraph (B), the court shall 

15 dismiss with prejudice the action for fail16 ure to timely file a petition. 

17 ‘‘(iii) FINAL RESPONSE.—If a civil ac18 tion is filed against the Secretary with re19 spect to any issue raised in a petition time20 ly filed under paragraph (1) in which the 

21 petitioner requests that the Secretary take 

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

23 aside, delay, rescind, withdraw, or prevent 

24 submission, review, or approval of an appli25 cation submitted under subsection (b)(2) 


pbinns on DSKJLVW7X2PROD with BILLS
9 

•S 562 IS

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

2 the Public Health Service Act before the 

3 Secretary has taken final agency action on 

4 the petition within the meaning of sub5 paragraph (C), the court shall dismiss 

6 without prejudice the action for failure to 

7 exhaust administrative remedies.’’; and 

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

9 so redesignated, by striking ‘‘as defined under 

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

11 meaning of subparagraph (C)’’; and 

12 (3) in paragraph (4)— 

13 (A) by striking ‘‘EXCEPTIONS’’ and all that 

14 follows through ‘‘This subsection does’’ and in15 serting ‘‘EXCEPTIONS.—This subsection does’’; 

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

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

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

19 adjusting the margins accordingly. 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS