S. 2062 — RAPID Reserve Act

This section establishes a program under which the Secretary of Health and Human Services awards contracts or cooperative agreements to eligible entities to maintain reserves and production capacity for critical drugs and their active pharmaceutical ingredients (APIs) determined to have vulnerable supply chains, with the Secretary required to publish a list of such drugs and APIs. Under the program, eligible entities must (1) maintain a 6-month reserve (or other reasonable quantity, as determined by the Secretary) of the specified API and finished drug product—regularly replenished with recently manufactured supply—in a satisfactory domestic establishment registered under section 510(b) of the Federal Food, Drug, and Cosmetic Act or a satisfactory foreign establishment registered under section 510(i) located in an Organisation for Economic Co-operation and Development (OECD) member country; (2) produce the drug or API at the Secretary's direction and in specified quantities; and (3) agree to transfer reserve API to other manufacturers if needed or permit Secretary-directed allocation during public health emergencies, natural disasters, or chemical, biological, radiological, or nuclear threats. (Thus, the program aims to mitigate drug shortages by ensuring ready stockpiles and surge production capability.) Not later than 180 days after enactment, the Secretary, in coordination with the Commissioner of Food and Drugs, must issue guidance on (1) factors for identifying vulnerable supply chains and how awards mitigate them; (2) entity eligibility criteria, including quality systems, domestic manufacturing, and surge capacity commitments; and (3) award requirements, such as excess capacity, redundancy, and advanced quality systems. In awarding contracts or agreements—which may include terms on procurement, storage, testing, and delivery, and support acquisition, construction, alteration, or renovation of non-federally owned facilities—the Secretary must prioritize entities using domestic establishments or sourcing key materials domestically or from OECD countries; maximize quality and resiliency while minimizing costs and vulnerabilities; and, to the greatest extent practicable, strengthen domestic manufacturing capacity.