I 118th CONGRESS 1st Session H. R. 4449 IN THE HOUSE OF REPRESENTATIVES June 30, 2023 Mr. Torres of New York introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To establish the Commission on Strengthening the Domestic Pharmaceutical Supply Chain, and for other purposes.

1. Short title This Act may be cited as the Pharmaceutical Security Production Act . 2. Commission on Strengthening the Domestic Pharmaceutical Supply Chain (a) Establishment There is established a commission to be known as the Commission on Strengthening the Domestic Pharmaceutical Supply Chain (in this section referred to as the Commission ) to assess the current security and vulnerabilities of the United States pharmaceutical supply chain. (b) Duties The duties of the Commission are the following: (1) Determine concrete timelines and metrics for success for the Pharmaceutical Manufacturing in America program of the Biomedical Advanced Research and Development Authority to produce advanced pharmaceutical ingredients for medicines included in the essential medicines list. (2) Evaluate and identify vulnerabilities in the existing United States pharmaceutical supply chain that could be exploited by foreign adversaries and nonstate actors. (3) Review and propose solutions to strengthen the domestic pharmaceutical manufacturing workforce to support increased production of advanced pharmaceutical ingredients and finished drugs. (4) Assess how Federal health care programs (as defined in section 1128B(f) of the Social Security Act (42 U.S.C. 1320a–7b(f))), the program established under chapter 89 of title 5, United States Code, and provider facilities can be used to create a viable financial market for domestically made advanced pharmaceutical ingredients and finished drug products. (5) Review the successes and failures of Operation Warp Speed and determine if any best practices for public-private partnerships can be used to bolster domestic manufacturing of advanced pharmaceutical ingredients and finished drug products. (6) Estimate the Federal funding necessary to catalyze and strengthen domestic pharmaceutical manufacturing. (7) Identify facilities throughout the United States that can be repurposed to produce advanced pharmaceutical ingredients, especially advanced pharmaceutical ingredients listed on the essential medicines list. (8) Identify partner countries where advanced pharmaceutical ingredients and finished drug products could be manufactured to reduce dependence on China and other countries. (9) Provide recommendations on legislative and regulatory actions that can be taken to address vulnerabilities in the United States pharmaceutical supply chain and increase the number of manufacturers of advanced pharmaceutical ingredients and finished drug products in the United States. (10) Identify and propose steps that can be taken to increase coordination among different Federal and State programs to increase manufacturing of domestic advanced pharmaceutical ingredients and finished drug products. (c) Membership (1) In general The Commission shall be composed of at least 6 but not more than 11 members as follows: (A) The National Security Advisor, who shall serve as co-chair. (B) The White House Domestic Policy Council, who shall serve as co-chair. (C) The Secretary of Health and Human Services. (D) The Secretary of Defense. (E) The Secretary of State. (F) The Secretary of Commerce. (G) Not more than 5 members as may be appointed by joint action of the co-chairs of the Commission, from among the employees and officers of appropriate Federal departments and agencies. (2) Terms Each member shall be appointed for the life of the Commission. (3) Quorum A majority of the Commission shall constitute a quorum but a lesser number may hold hearings. (d) Powers of Commission The Commission may, for the purpose of carrying out this Act, hold hearings, sit and act at times and places, take testimony, and receive evidence as the Commission considers appropriate. (e) Reports (1) In general Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date of the termination of the Commission under subsection (f), the Commission shall submit to Congress a report detailing the findings, conclusions, and recommendations of the Commission in fulfilling its duties under subsection (b). (2) Form of reports The reports described in paragraph (1) shall be submitted in unclassified form but may include a classified annex. (f) Termination The Commission shall terminate on the date that is 4 years after the date of enactment of this Act. (g) Essential medicines list defined In this section, the term essential medicines list means the list of the Food and Drug Administration described in section 3(c) of Executive Order 13944.