RAPID Reserve Act
The RAPID Reserve Act would create a government-backed program to improve the resilience of the U.S. drug supply for products with vulnerable supply chains. The Secretary of Health and Human Services would contract with eligible entities to maintain rolling reserves of selected drugs and their active pharmaceutical ingredients (APIs), and to produce or replenish those drugs as directed. The program emphasizes domestic production and sourcing where feasible, with reserves stored in U.S. facilities or in OECD-country facilities that are FDA-registered, and it allows the Secretary to allocate or transfer reserves in emergencies or public health threats. The act also directs the development of guidance on eligibility and reserve requirements, requires reporting to Congress, and authorizes funding of up to $500 million for fiscal year 2026.
Key Points
- 1Rolling reserves: Eligible entities must maintain a six-month reserve of both the API and the finished drug, regularly replenished with newly manufactured material, in a domestic facility or in an OECD-country facility that meets FDA registration standards.
- 2Production and control: The Secretary can direct production of the drug or its API under contract terms and require the entity to participate in an arrangement to transfer reserves to other manufacturers if needed, and to allocate reserves during emergencies or other qualifying events.
- 3Eligibility and criteria: The Secretary will publish which drugs and APIs are eligible, based on vulnerability, public health emergency relevance, and potential shortages. Eligibility requires partnerships with capable manufacturers and strong good manufacturing practices (GMP), including domestic or OECD-based capabilities.
- 4Guidance and preferences: Within 180 days, the Secretary (with FDA) will issue guidance on vulnerability factors, eligibility criteria, and award requirements such as capacity, redundancy, and quality systems. Preference is given to entities using domestic facilities or domestic-starting materials, and awards should strengthen U.S. manufacturing resilience.
- 5Contract terms and flexibility: Contracts may cover procurement, storage, testing, delivery, and may support acquisition or renovation of non-federally owned facilities to boost state/local preparedness or national supply.
- 6Reporting and oversight: The Secretary must report every two years to Congress on the list of eligible drugs and the program’s effectiveness, while protecting national security.
- 7Funding: The bill authorizes $500 million for fiscal year 2026 to implement the program.