Ensuring Access to Lifesaving Drugs Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3793 To amend the Federal Food, Drug, and Cosmetic Act to require manufactur- ers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 5, 2023 Ms. SLOTKIN introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. 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 Access to 4 Lifesaving Drugs Act of 2023’’. 5 VerDate Sep 11 2014 23:32 Jun 27, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3793.IH H3793 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3793 IH SEC. 2. EXTENDED EXPIRATION DATES FOR LIFE-SAVING 1 DRUGS. 2 (a) IN GENERAL.—The Federal Food, Drug, and 3 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by in- 4 serting after section 506L of such Act (21 U.S.C. 356l) 5 the following new section: 6 ‘‘SEC. 506M. EXTENDED EXPIRATION DATES FOR LIFE-SAV- 7 ING DRUGS. 8 ‘‘(a) IN GENERAL.—A manufacturer of a life-saving 9 drug shall— 10 ‘‘(1) submit to the Secretary data and informa- 11 tion as required by subsection (b)(1); 12 ‘‘(2) conduct and submit the results, data, and 13 information generated by any studies required under 14 subsection (b)(2); and 15 ‘‘(3) make any labeling change described in 16 subsection (c) by the date specified by the Secretary 17 pursuant to such subsection. 18 ‘‘(b) DATA AND INFORMATION.— 19 ‘‘(1) IN GENERAL.—The Secretary may issue 20 an order requiring the manufacturer of a life-saving 21 drug to submit, in such manner as the Secretary 22 may prescribe, data and information from any stage 23 of development of the drug that are adequate to as- 24 sess the stability of the drug to determine the long- 25 est supported expiration date. 26 VerDate Sep 11 2014 23:32 Jun 27, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3793.IH H3793 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3793 IH ‘‘(2) LACK OF DATA AND INFORMATION.—If the 1 data and information required pursuant to an order 2 issued under paragraph (1) are not available or are 3 insufficient, as determined by the Secretary, the Sec- 4 retary may issue an order requiring the manufac- 5 turer of the drug— 6 ‘‘(A) to conduct studies, which may be a 7 continuation of ongoing studies, to provide data 8 and information adequate to assess the stability 9 of the drug and to determine the longest sup- 10 ported expiration date; and 11 ‘‘(B) to submit such data and information 12 to the Secretary in such manner as the Sec- 13 retary may prescribe in the order. 14 ‘‘(c) LABELING.—The Secretary may issue an order 15 requiring the manufacturer of a life-saving drug, by a date 16 determined by the Secretary in consultation with the spon- 17 sor of the drug, to make any labeling change regarding 18 the expiration date or storage and handling of the drug 19 that the Secretary determines to be appropriate based on 20 the data and information required to be submitted under 21 this section or any other data and information available 22 to the Secretary. 23 ‘‘(d) DEFINITIONS.—In this section: 24 VerDate Sep 11 2014 23:32 Jun 27, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3793.IH H3793 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3793 IH ‘‘(1) LIFE-SAVING DRUG.—The term ‘life-saving 1 drug’ means a drug, that is— 2 ‘‘(A)(i) a medical countermeasure; or 3 ‘‘(ii) on the drug shortage list under sec- 4 tion 506E or determined by the Secretary to be 5 at risk of shortage; and 6 ‘‘(B)(i) life-supporting; 7 ‘‘(ii) life-sustaining; or 8 ‘‘(iii) intended for use in the prevention or 9 treatment of a debilitating disease or condition 10 in humans or animals, including any such drug 11 used in emergency medical care or during sur- 12 gery or any such drug that is critical to the 13 public health during a public health emergency 14 declared by the Secretary under section 319 of 15 the Public Health Service Act. 16 ‘‘(2) MEDICAL COUNTERMEASURE.—The term 17 ‘medical countermeasure’ means a countermeasure 18 as defined in section 565(a). 19 ‘‘(e) CONFIDENTIALITY.—Nothing in this section 20 shall be construed as authorizing the Secretary to disclose 21 any information that is a trade secret or confidential infor- 22 mation subject to section 552(b)(4) of title 5, United 23 States Code, or section 1905 of title 18, United States 24 Code.’’. 25 VerDate Sep 11 2014 23:32 Jun 27, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3793.IH H3793 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3793 IH (b) PROHIBITED ACT.—Section 301 of the Federal 1 Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 2 amended by section 3503(a)(1)(A) of division FF of Pub- 3 lic Law 117–328, is amended by inserting at the end the 4 following new subsection: 5 ‘‘(jjj) The failure to comply with any order issued 6 under section 506M.’’. 7 (c) PENALTIES.—Subsection (b) of section 303 of the 8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) 9 is amended by inserting at the end the following: 10 ‘‘(9) If a manufacturer of a life-saving drug fails to 11 submit data and information as required under section 12 506M(b)(1), fails to conduct or submit the data and infor- 13 mation generated by studies as required under section 14 506M(b)(2), or fails to make a labeling change as required 15 under section 506M(c), such manufacturer shall be subject 16 to a civil penalty of not more than $10,000 for the first 17 day on which the violation occurs and not more than 18 $10,000 for each subsequent day on which the violation 19 is not corrected.’’. 20 Æ VerDate Sep 11 2014 23:32 Jun 27, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3793.IH H3793 kjohnson on DSK79L0C42PROD with BILLS