Bill > HR3955

This bill establishes a new program to improve the resilience of critical drug supply chains in the United States by creating strategic reserves of essential drugs and active pharmaceutical ingredients (APIs). The Secretary of Health and Human Services will award contracts or cooperative agreements to eligible entities, such as drug manufacturers, API producers, or distributors, to maintain at least a 6-month reserve of critical drugs and their ingredients that are deemed vulnerable to supply disruptions. Eligible entities must agree to maintain these reserves in domestic or OECD-country facilities, be prepared to quickly ramp up production when directed, and be willing to transfer or reallocate their reserves during public health emergencies or national threats. The bill prioritizes domestic manufacturing and aims to strengthen the U.S. pharmaceutical production capacity by giving preference to entities with strong domestic manufacturing capabilities, quality systems, and commitment to maintaining surge production capacity. The program will cover drugs that are approved generics or biosimilars, likely to be needed in emergencies, and have supply chain vulnerabilities such as concentrated manufacturing or few producers. The Secretary must issue guidance on selecting eligible drugs and entities, and will report to Congress every two years on the program's progress. The bill authorizes $500 million in funding for fiscal year 2026 to implement this initiative.

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https://www.congress.gov/bill/119th-congress/house-bill/3955/all-info