America First Vaccine Act

II 116TH CONGRESS 2D SESSION S. 4542 To prohibit distribution abroad of COVID–19 vaccines developed with the support of Federal funding until the domestic need for the vaccine has been met. IN THE SENATE OF THE UNITED STATES SEPTEMBER 9, 2020 Mr. TILLIS introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs A BILL To prohibit distribution abroad of COVID–19 vaccines devel- oped with the support of Federal funding until the do- mestic need for the vaccine has been met. 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 ‘‘America First Vaccine 4 Act’’. 5 SEC. 2. COVID–19 VACCINE DISTRIBUTION. 6 (a) CERTIFICATION REQUIREMENT.— 7 (1) IN GENERAL.—Notwithstanding any other 8 provision of law, subject to paragraph (2), a manu- 9 VerDate Sep 11 2014 17:41 Sep 10, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4542.IS S4542 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4542 IS facturer of a vaccine described in subsection (b) that 1 is headquartered in the United States may not dis- 2 tribute such vaccine outside of the United States un- 3 less the Secretary of Health and Human Services 4 (referred to in this section as the ‘‘Secretary’’), in 5 consultation with the Commissioner of Food and 6 Drugs, certifies that domestic need for the vaccine 7 already has been met. 8 (2) WAIVER.—The Secretary may waive the 9 certification requirement under paragraph (1) with 10 respect to a vaccine described in subsection (b) and 11 permit the distribution of such vaccine outside of the 12 United States, if the Secretary determines that such 13 waiver and distribution is in the interest of the 14 American public health. 15 (b) VACCINES DESCRIBED.—A vaccine described in 16 this subsection is a COVID–19 vaccine that— 17 (1) is authorized under section 564 of the Fed- 18 eral Food, Drug, and Cosmetic Act (21 U.S.C. 19 360bbb–3) or licensed under section 351 of the Pub- 20 lic Health Service Act (42 U.S.C. 262); and 21 (2) was developed with support of Federal fund- 22 ing made available under the Coronavirus Prepared- 23 ness and Response Supplemental Appropriations Act 24 (Public Law 116–123), the Families First 25 VerDate Sep 11 2014 17:41 Sep 10, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4542.IS S4542 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4542 IS Coronavirus Response Act (Public Law 116–127), 1 the Coronavirus Aid, Relief, and Economic Security 2 Act (Public Law 116–136), or the Paycheck Protec- 3 tion Program and Health Care Enhancement Act 4 (Public Law 116–139). 5 (c) VIOLATIONS.—In the case of a manufacturer who 6 violates subsection (a), such manufacturer shall be re- 7 quired to reimburse the Federal Government for all 8 amounts received by the manufacturer in support of devel- 9 opment of the vaccine, plus interest in an amount deter- 10 mined by the Secretary of the Treasury. 11 (d) RULE OF CONSTRUCTION.—Nothing in this Act 12 shall be construed to limit or otherwise restrict the Sec- 13 retary’s authority to enter into bilateral or multilateral 14 agreements with international manufacturers to procure 15 vaccines described in subsection (b) for the people of the 16 United States. 17 Æ VerDate Sep 11 2014 17:41 Sep 10, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S4542.IS S4542 pamtmann on DSKBC07HB2PROD with BILLS