A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

II 117TH CONGRESS 1ST SESSION S. 1508 To provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes. IN THE SENATE OF THE UNITED STATES APRIL 29, 2021 Mr. MARSHALL (for himself, Ms. SMITH, and Mr. CASSIDY) introduced the fol- lowing bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, 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 VerDate Sep 11 2014 01:35 May 25, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1508.IS S1508 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1508 IS SECTION 1. USING EMERGENCY USE AUTHORIZATION DATA 1 AND REAL WORLD EVIDENCE GATHERED 2 DURING AN EMERGENCY TO SUPPORT PRE- 3 MARKET APPLICATIONS FOR DRUGS, BIO- 4 LOGICAL PRODUCTS, AND DEVICES. 5 (a) IN GENERAL.—Data generated to support an au- 6 thorization under section 564 of the Federal Food, Drug, 7 and Cosmetic Act (21 U.S.C. 360bbb–3) with respect to 8 a drug, biological product, or device, and real world evi- 9 dence relating to such drug, biological product, or device 10 used pursuant to such authorization, may constitute valid 11 scientific evidence, and shall be considered for purposes 12 of— 13 (1) reviewing submissions pursuant to section 14 505 of the Federal Food, Drug, and Cosmetic Act 15 (21 U.S.C. 355) and section 351 of the Public 16 Health Service Act (42 U.S.C. 262); 17 (2) reviewing submissions pursuant to sections 18 510(k), 513(f), and 515 of the Federal Food, Drug, 19 and Cosmetic Act (21 U.S.C. 21 U.S.C. 360(k), 20 360c(f), or 360e); and 21 (3) otherwise meeting the requirements of such 22 Act and such section 351 of the Public Health Serv- 23 ice Act. 24 (b) APPLICABILITY OF CERTAIN CATEGORIZATIONS 25 FOR PREMARKET DEVICE REVIEW.—In the case of a de- 26 VerDate Sep 11 2014 01:35 May 25, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1508.IS S1508 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1508 IS vice receiving an authorization under section 564 of the 1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 360bbb–3) for which the Secretary has determined, in ac- 3 cordance with subsection (m) of such section, that a lab- 4 oratory examination or procedure associated with such de- 5 vice is deemed to be in the category of examinations and 6 procedures described in section 353(d)(3) of the Public 7 Health Service Act (42 U.S.C. 262), such determination 8 shall apply with regard to a submission pursuant to sec- 9 tion 510(k), 513(f), or 515 of the Federal Food, Drug, 10 and Cosmetic Act (21 U.S.C. 21 U.S.C. 360(k), 360c(f), 11 or 360e) for such device, unless the Secretary (taking into 12 account any applicable conditions specified pursuant to 13 subsection (m)(2) of section 564 of the Federal Food, 14 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3)) identifies 15 new information not included in the request for authoriza- 16 tion that indicates that the criteria under section 17 353(d)(3) of the Public Health Service Act (42 U.S.C. 18 262) are not met. 19 (c) RULE OF CONSTRUCTION.—Nothing in this sec- 20 tion shall be construed as altering the review standards 21 or otherwise affecting the requirements under section 505, 22 510(k), 513(f), or 515 of the Federal Food, Drug, and 23 Cosmetic Act (21 U.S.C. 21 U.S.C. 355, 360(k), 360c(f), 24 or 360e) or under section 351 of the Public Health Service 25 VerDate Sep 11 2014 01:35 May 25, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1508.IS S1508 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1508 IS Act (42 U.S.C. 262) for the clearance or approval of a 1 device, approval of a drug, or licensure of a biological 2 product. 3 Æ VerDate Sep 11 2014 01:35 May 25, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S1508.IS S1508 kjohnson on DSK79L0C42PROD with BILLS