SAVE Act

II 116TH CONGRESS 2D SESSION S. 4427 To provide for transparency in emergency use authorization of vaccine products, and for other purposes. IN THE SENATE OF THE UNITED STATES AUGUST 4, 2020 Ms. HASSAN (for herself, Mr. BRAUN, and Ms. MURKOWSKI) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for transparency in emergency use authorization of vaccine products, 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 ‘‘Safe Authorization for 4 Vaccines during Emergencies Act’’ or the ‘‘SAVE Act’’. 5 SEC. 2. TRANSPARENCY IN EMERGENCY USE AUTHORIZA- 6 TION OF VACCINE PRODUCTS. 7 (a) EMERGENCY USE AUTHORIZATIONS.— 8 VerDate Sep 11 2014 03:48 Aug 21, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4427.IS S4427 kjohnson on DSK79L0C42PROD with BILLS 2 •S 4427 IS (1) IN GENERAL.—Section 564 of the Federal 1 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 2 3) is amended by adding at the end the following: 3 ‘‘(n) REQUIREMENTS WITH RESPECT TO VACCINE 4 PRODUCTS DURING PUBLIC HEALTH EMERGENCIES.— 5 ‘‘(1) EMERGENCY MEETING AND RECOMMENDA- 6 TIONS.— 7 ‘‘(A) EMERGENCY MEETING.—During a 8 public health emergency declared by the Sec- 9 retary under section 319 of the Public Health 10 Service Act and with respect to a request to au- 11 thorize the use of an unapproved product that 12 is a vaccine or an unapproved use of an ap- 13 proved product that is a vaccine intended to ad- 14 dress the public health threat that is the sub- 15 ject of such public health emergency, prior to 16 authorizing use of such product, subject to sub- 17 paragraph (B), the Secretary shall convene a 18 meeting at which the Food and Drug Adminis- 19 tration and the sponsor of the product present 20 data and information on the product to the 21 Vaccines and Related Biological Products Advi- 22 sory Committee for the purpose of reviewing 23 and providing recommendations with respect to 24 emergency use of the product. 25 VerDate Sep 11 2014 03:48 Aug 21, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4427.IS S4427 kjohnson on DSK79L0C42PROD with BILLS 3 •S 4427 IS ‘‘(B) EXCEPTION.—If the Secretary, in 1 consultation with the Commissioner, determines 2 that a meeting under subparagraph (A) with re- 3 spect to a product described in such subpara- 4 graph would not be in the public interest, the 5 Secretary may make a determination not to 6 convene such a meeting. In the event that the 7 Secretary determines not to convene such a 8 meeting pursuant to this subparagraph, the 9 Secretary shall issue a report to the Committee 10 on Health, Education, Labor, and Pensions of 11 the Senate and the Committee on Energy and 12 Commerce of the House of Representatives that 13 includes justification and relevant public health 14 grounds for such determination. 15 ‘‘(2) REQUIREMENT TO SEEK LICENSURE.—An 16 authorization under this section with respect to an 17 unapproved product that is a vaccine or an unap- 18 proved use of an approved product that is a vaccine 19 shall be conditioned on the sponsor seeking licensure 20 of the product, or the use, as applicable, under sec- 21 tion 351 of the Public Health Service Act, at the 22 discretion of the Secretary, within a time period de- 23 termined by the Secretary.’’. 24 VerDate Sep 11 2014 03:48 Aug 21, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4427.IS S4427 kjohnson on DSK79L0C42PROD with BILLS 4 •S 4427 IS (2) CONFIDENTIAL INFORMATION.—Section 1 564(h)(1) of the Federal Food, Drug, and Cosmetic 2 Act (21 U.S.C. 360bbb–3(h)(1)) is amended— 3 (A) by inserting ‘‘, including a summary 4 review,’’ after ‘‘data or information’’; 5 (B) by striking ‘‘505(i), 512(j), or 520(g)’’ 6 and inserting ‘‘505, 510(k), 512(j), 513(f), 515, 7 520(g), or 564 of this Act or section 351 of the 8 Public Health Service Act’’; and 9 (C) by striking ‘‘may indirectly reveal the 10 existence of such application’’ and inserting ‘‘, 11 including a summary review, may indirectly re- 12 veal the existence of such application or contain 13 data or information submitted in an application 14 under such sections’’. 15 (b) RECOMMENDATIONS WITH RESPECT TO VAC- 16 CINES TO ADDRESS A PUBLIC HEALTH EMERGENCY.— 17 Section 319 of the Public Health Service Act (42 U.S.C. 18 247d) is amended by adding at the end the following: 19 ‘‘(c) RECOMMENDATIONS.—During a public health 20 emergency declared by the Secretary under subsection (a), 21 not later than 15 days after the authorization under sec- 22 tion 564 of the Federal Food, Drug, and Cosmetic Act 23 of an unapproved product that is a vaccine or an unap- 24 proved use of an approved product that is a vaccine in- 25 VerDate Sep 11 2014 22:42 Aug 26, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4427.IS S4427 kjohnson on DSK79L0C42PROD with BILLS 5 •S 4427 IS tended to address the public health threat that is the sub- 1 ject of such public health emergency, the Advisory Com- 2 mittee on Immunization Practices shall submit to the Di- 3 rector of the Centers for Disease Control and Prevention, 4 the Secretary, the Committee on Health, Education, 5 Labor, and Pensions of the Senate, and the Committee 6 on Energy and Commerce of the House of Representa- 7 tives— 8 ‘‘(1) recommendations regarding vaccination, 9 including prioritization of populations for which the 10 vaccine is authorized; or 11 ‘‘(2) a report recommending that the Secretary 12 seek additional data or information in order for the 13 committees to develop recommendations described in 14 paragraph (1).’’. 15 Æ VerDate Sep 11 2014 03:48 Aug 21, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S4427.IS S4427 kjohnson on DSK79L0C42PROD with BILLS