Securing America’s Pharmaceutical Supply Chain Act

I 116TH CONGRESS 2D SESSION H. R. 6731 To require executive agencies to purchase pharmaceuticals from the United States, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 5, 2020 Mr. STAUBER (for himself and Mr. GARAMENDI) introduced the following bill; which was referred to the Committee on Oversight and Reform, and in addition to the Committee on Ways and Means, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To require executive agencies to purchase pharmaceuticals from the United States, 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 ‘‘Securing America’s 4 Pharmaceutical Supply Chain Act’’. 5 SEC. 2. REQUIREMENT TO PURCHASE PHARMACEUTICALS 6 FROM THE UNITED STATES. 7 (a) IN GENERAL.—Except as provided in subsection 8 (b), the head of an executive agency may only purchase 9 VerDate Sep 11 2014 00:12 May 16, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6731.IH H6731 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6731 IH a covered drug if the drug is over 50 percent sourced, 1 manufactured, and assembled in the United States. 2 (b) EXCEPTION.—The head of an executive agency 3 may waive the requirement of subsection (a)— 4 (1) if the covered drug is not available in suffi- 5 cient quantity or quality as over 50 percent sourced, 6 manufactured, and assembled in the United States; 7 or 8 (2) during an emergency period (as defined in 9 section 1135(g)(1)(A) of the Social Security Act (42 10 U.S.C. 1320b–5(g)(1)(A)). 11 (c) MODIFICATIONS TO TRADE AGREEMENTS.— 12 (1) IN GENERAL.—Not later than 30 days after 13 the date of the enactment of this Act, the United 14 States Trade Representative shall modify United 15 States product coverage under all free trade agree- 16 ments and the World Trade Organization Agreement 17 on Government Procurement to exclude coverage of 18 essential medicines and medical countermeasures. 19 (2) MODIFICATION OF WAIVERS.—Subsequent 20 to the modifications made under paragraph (1), the 21 United States Trade Representative shall make any 22 necessary corresponding modifications of existing 23 waivers under section 301 of the Trade Agreements 24 Act of 1979 (19 U.S.C. 2511). 25 VerDate Sep 11 2014 00:12 May 16, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6731.IH H6731 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 6731 IH (3) NOTIFICATION TO THE PRESIDENT.—Sub- 1 sequent to the modifications made under paragraphs 2 (1) or (2), the United States Trade Representative 3 shall notify the Director of the Office of Manage- 4 ment and Budget. 5 (d) DEFINITIONS.—In this section: 6 (1) COVERED DRUG.—The term ‘‘covered drug’’ 7 means a drug (including the active pharmaceutical 8 ingredients thereof) marketed in the United States 9 pursuant to an approval or licensure under sub- 10 section (c) or (j) of section 505 of the Federal Food, 11 Drug, and Cosmetic Act (21 U.S.C. 355) or under 12 subsection (a) or (k) of section 351 of the Public 13 Health Service Act (42 U.S.C. 262). 14 (2) EXECUTIVE AGENCY.—The term ‘‘executive 15 agency’’ has the meaning given that term in section 16 133 of title 41, United States Code. 17 (3) UNITED STATES.—The term ‘‘United 18 States’’ means each of the several States, the Dis- 19 trict of Columbia, and each territory or possession of 20 the United States. 21 (e) SEVERABILITY CLAUSE.—If any provision of this 22 Act (or the application of that provision to particular per- 23 sons or circumstances) is held invalid, the remainder of 24 VerDate Sep 11 2014 00:12 May 16, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6731.IH H6731 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 6731 IH this Act (or the application of that provision to other per- 1 sons or circumstances) shall not be affected. 2 (f) EFFECTIVE DATE.—The provisions of this section 3 shall apply beginning on the date that is one year after 4 the last day of the emergency period (as defined in para- 5 graph (1)(B) of section 1135(g) of the Social Security Act 6 (42 U.S.C. 1320b–5(g)). 7 Æ VerDate Sep 11 2014 00:12 May 16, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H6731.IH H6731 kjohnson on DSK79L0C42PROD with BILLS