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) in- troduced the following bill; which was read twice and referred to the Com- mittee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Ensuring Timely Ac- 4 cess to Generics Act of 2021’’. 5 SEC. 2. ENSURING TIMELY ACCESS TO GENERICS. 6 Section 505(q) of the Federal Food, Drug, and Cos- 7 metic Act (21 U.S.C. 355(q)) is amended— 8 (1) in paragraph (1)— 9 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 562 IS (A) in subparagraph (A)(i), by inserting ‘‘, 1 10.31,’’ after ‘‘10.30’’; 2 (B) in subparagraph (E)— 3 (i) by striking ‘‘application and’’ and 4 inserting ‘‘application or’’; 5 (ii) by striking ‘‘If the Secretary’’ and 6 inserting the following: 7 ‘‘(i) IN GENERAL.—If the Secretary’’; 8 and 9 (iii) by striking the second sentence 10 and inserting the following: 11 ‘‘(ii) PRIMARY PURPOSE OF DELAY- 12 ING.— 13 ‘‘(I) IN GENERAL.—In deter- 14 mining whether a petition was sub- 15 mitted with the primary purpose of 16 delaying an application, the Secretary 17 may consider the following factors: 18 ‘‘(aa) Whether the petition 19 was submitted in accordance with 20 paragraph (2)(B), based on when 21 the petitioner knew or reasonably 22 should have known the relevant 23 information relied upon to form 24 the basis of such petition. 25 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 562 IS ‘‘(bb) Whether the petitioner 1 has submitted multiple or serial 2 petitions or supplements to peti- 3 tions raising issues that reason- 4 ably could have been known to 5 the petitioner at the time of sub- 6 mission of the earlier petition or 7 petitions. 8 ‘‘(cc) Whether the petition 9 was submitted close in time to a 10 known, first date upon which an 11 application under subsection 12 (b)(2) or (j) of this section or 13 section 351(k) of the Public 14 Health Service Act could be ap- 15 proved. 16 ‘‘(dd) Whether the petition 17 was submitted without relevant 18 data or information in support of 19 the scientific positions forming 20 the basis of such petition. 21 ‘‘(ee) Whether the petition 22 raises the same or substantially 23 similar issues as a prior petition 24 to which the Secretary has re- 25 VerDate 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 sponded substantively already, in- 1 cluding if the subsequent submis- 2 sion follows such response from 3 the Secretary closely in time. 4 ‘‘(ff) Whether the petition 5 requests changing the applicable 6 standards that other applicants 7 are required to meet, including 8 requesting testing, data, or label- 9 ing standards that are more on- 10 erous or rigorous than the stand- 11 ards the Secretary has deter- 12 mined to be applicable to the list- 13 ed drug, reference product, or pe- 14 titioner’s version of the same 15 drug. 16 ‘‘(gg) The petitioner’s record 17 of submitting petitions to the 18 Food and Drug Administration 19 that have been determined by the 20 Secretary to have been submitted 21 with the primary purpose of 22 delay. 23 ‘‘(hh) Other relevant and 24 appropriate factors, which the 25 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 562 IS Secretary shall describe in guid- 1 ance. 2 ‘‘(II) GUIDANCE.—The Secretary 3 may issue or update guidance, as ap- 4 propriate, to describe factors the Sec- 5 retary considers in accordance with 6 subclause (I).’’; 7 (C) by adding at the end the following: 8 ‘‘(iii) REFERRAL TO THE FEDERAL 9 TRADE COMMISSION.—The Secretary shall 10 establish procedures for referring to the 11 Federal Trade Commission any petition or 12 supplement to a petition that the Secretary 13 determines was submitted with the primary 14 purpose of delaying approval of an applica- 15 tion. Such procedures shall include notifi- 16 cation to the petitioner by the Secretary.’’; 17 (D) by striking subparagraph (F); 18 (E) by redesignating subparagraphs (G) 19 through (I) as subparagraphs (F) through (H), 20 respectively; and 21 (F) in subparagraph (H), as so redesig- 22 nated, by striking ‘‘submission of this petition’’ 23 and inserting ‘‘submission of this document’’; 24 (2) in paragraph (2)— 25 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 562 IS (A) by redesignating subparagraphs (A) 1 through (C) as subparagraphs (C) through (E), 2 respectively; 3 (B) by inserting before subparagraph (C), 4 as so redesignated, the following: 5 ‘‘(A) IN GENERAL.—A person shall submit 6 a petition to the Secretary under paragraph (1) 7 before filing a civil action in which the person 8 seeks to set aside, delay, rescind, withdraw, or 9 prevent submission, review, or approval of an 10 application submitted under subsection (b)(2) 11 or (j) of this section or section 351(k) of the 12 Public Health Service Act. Such petition and 13 any supplement to such a petition shall describe 14 all information and arguments that form the 15 basis of the relief requested in any civil action 16 described in the previous sentence. 17 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PE- 18 TITION.—A petition and any supplement to a 19 petition shall be submitted within 60 days after 20 the person knew, or reasonably should have 21 known, the information that forms the basis of 22 the request made in the petition or supple- 23 ment.’’; 24 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 562 IS (C) in subparagraph (C), as so redesig- 1 nated— 2 (i) in the heading, by striking ‘‘WITH- 3 IN 150 DAYS’’; 4 (ii) in clause (i), by striking ‘‘during 5 the 150-day period referred to in para- 6 graph (1)(F),’’; and 7 (iii) by amending clause (ii) to read as 8 follows: 9 ‘‘(ii) on or after the date that is 151 10 days after the date of submission of the 11 petition, the Secretary approves or has ap- 12 proved the application that is the subject 13 of the petition without having made such a 14 final decision.’’; 15 (D) by amending subparagraph (D), as so 16 redesignated, to read as follows: 17 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC- 18 TIONS.— 19 ‘‘(i) PETITION.—If a person files a 20 civil action against the Secretary in which 21 a person seeks to set aside, delay, rescind, 22 withdraw, or prevent submission, review, or 23 approval of an application submitted under 24 subsection (b)(2) or (j) of this section or 25 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 562 IS section 351(k) of the Public Health Service 1 Act without complying with the require- 2 ments of subparagraph (A), the court shall 3 dismiss without prejudice the action for 4 failure to exhaust administrative remedies. 5 ‘‘(ii) TIMELINESS.—If a person files a 6 civil action against the Secretary in which 7 a person seeks to set aside, delay, rescind, 8 withdraw, or prevent submission, review, or 9 approval of an application submitted under 10 subsection (b)(2) or (j) of this section or 11 section 351(k) of the Public Health Service 12 Act without complying with the require- 13 ments of subparagraph (B), the court shall 14 dismiss with prejudice the action for fail- 15 ure to timely file a petition. 16 ‘‘(iii) FINAL RESPONSE.—If a civil ac- 17 tion is filed against the Secretary with re- 18 spect to any issue raised in a petition time- 19 ly filed under paragraph (1) in which the 20 petitioner requests that the Secretary take 21 any form of action that could, if taken, set 22 aside, delay, rescind, withdraw, or prevent 23 submission, review, or approval of an appli- 24 cation submitted under subsection (b)(2) 25 VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 562 IS or (j) of this section or section 351(k) of 1 the Public Health Service Act before the 2 Secretary has taken final agency action on 3 the petition within the meaning of sub- 4 paragraph (C), the court shall dismiss 5 without prejudice the action for failure to 6 exhaust administrative remedies.’’; and 7 (E) in clause (iii) of subparagraph (E), as 8 so redesignated, by striking ‘‘as defined under 9 subparagraph (2)(A)’’ and inserting ‘‘within the 10 meaning of subparagraph (C)’’; and 11 (3) in paragraph (4)— 12 (A) by striking ‘‘EXCEPTIONS’’ and all that 13 follows through ‘‘This subsection does’’ and in- 14 serting ‘‘EXCEPTIONS.—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. 19 Æ VerDate Sep 11 2014 04:02 Apr 01, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\S562.IS S562 pbinns on DSKJLVW7X2PROD with BILLS