Securing America’s Pharmaceutical Supply Chain Act

To require executive agencies to purchase pharmaceuticals from the United States, and for other purposes. 1. Short title This Act may be cited as the Securing America’s Pharmaceutical Supply Chain Act 2. Requirement to purchase pharmaceuticals from the United States (a) In general Except as provided in subsection (b), the head of an executive agency may only purchase a covered drug if the drug is over 50-percent sourced, manufactured, and assembled in the United States. (b) Exception The head of an executive agency may waive the requirement of subsection (a)— (1) if the covered drug is not available in sufficient quantity or quality as over 50-percent sourced, manufactured, and assembled in the United States; or (2) during an emergency period (as defined in section 1135(g)(1)(A) of the Social Security Act ( 42 U.S.C. 1320b–5(g)(1)(A) (c) Modifications to trade agreements (1) In general Not later than 30 days after the date of the enactment of this Act, the United States Trade Representative shall modify United States product coverage under all free trade agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. (2) Modification of waivers Subsequent to the modifications made under paragraph (1), the United States Trade Representative shall make any necessary corresponding modifications of existing waivers under section 301 of the Trade Agreements Act of 1979 ( 19 U.S.C. 2511 (3) Notification to the President Subsequent to the modifications made under paragraphs (1) or (2), the United States Trade Representative shall notify the Director of the Office of Management and Budget. (d) Definitions In this section: (1) Covered drug The term covered drug 21 U.S.C. 355 42 U.S.C. 262 (2) Executive agency The term executive agency (3) United States The term United States (e) Severability clause If any provision of this Act (or the application of that provision to particular persons or circumstances) is held invalid, the remainder of this Act (or the application of that provision to other persons or circumstances) shall not be affected. (f) Effective date The provisions of this section shall apply beginning on the date that is one year after the last day of the emergency period (as defined in paragraph (1)(B) of section 1135(g) of the Social Security Act ( 42 U.S.C. 1320b–5(g)

Summary: Securing America's Pharmaceutical Supply Chain Act This bill allows an executive agency to purchase a drug approved or licensed by the Food and Drug Administration only if the drug is over 50% sourced, manufactured, and assembled in the United States. This requirement may be waived (1) if the drug is not available in sufficient quantity or quality as over 50% sourced, manufactured, and assembled in the United States; or (2) during an emergency. The U.S. Trade Representative (USTR) shall modify U.S. product coverage under all free trade agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. Subsequent to such modifications, the USTR shall make any necessary corresponding modifications of existing waivers and notify the Office of Management and Budget.