Map
Live
US Code
Officials
Committees
Legislation
Rankings
Nominations
Holds
Stocks
Open search page

Text Versions

Text as it was Introduced in House
June 12, 2025
View
Congress.wiki Alpha
AboutHow Congress WorksSupport UsRoadmapPrivacy PolicyTerms of Service

This is not an official government website.

Copyright © 2026 PLEJ LC. All rights reserved.

AI Insights

Analyzed 1 of 1 sections

Summary

Directs the Secretary of Health and Human Services to contract with eligible companies to create and hold domestic reserves of critical drugs and their active pharmaceutical ingredients (APIs), strengthen U.S. production capacity, and require those companies to replenish and produce drugs on the Secretary’s direction during shortages. The Secretary must issue selection and program guidance within 180 days, report to Congress every two years after the first award, and the program is authorized $500,000,000 for fiscal year 2026.

Key Points

  • Authorizes HHS to contract with companies to build and hold domestic reserves of critical drugs and APIs.
  • Requires participating entities to maintain about six months’ supply (or an alternate amount set by the Secretary) and to replenish inventory.
  • Gives the Secretary authority to direct producers to manufacture drugs and to transfer or allocate API reserves during shortages or emergencies.
  • Requires HHS to issue guidance on selection and program rules within 180 days of enactment.
  • Mandates biennial reports to Congress after the first award on program implementation and reserve status.
  • Authorizes $500 million for fiscal year 2026 to carry out the program (authorization, not direct appropriations).
  • Aims to strengthen domestic pharmaceutical production capacity and reduce reliance on foreign supply chains for critical medicines.
  • Imposes contractual obligations on participating companies around storage, replenishment, and government-directed production.

Categories & Tags

Funding
$500M authorized
Agencies
Department of Health and Human Services (HHS)
Food and Drug Administration (Commissioner of Food and Drugs)
Assistant Secretary for Preparedness and Response (ASPR)
Centers for Disease Control and Prevention (CDC)

Provisions

16 items

Authorize the Secretary of Health and Human Services to award contracts or cooperative agreements to eligible entities for drugs and active pharmaceutical ingredients that the Secretary determines are critical and have vulnerable supply chains; the Secretary must publish the list of such drugs and APIs.

authorization
Affects: Secretary of Health and Human Services (HHS)

Require an eligible entity under a contract or cooperative agreement to maintain, 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 OECD country, a 6-month reserve or other reasonable quantity (as determined by the Secretary) of: (i) the active pharmaceutical ingredient of the eligible drug, regularly replenished with recently manufactured supply; and (ii) the finished eligible drug product, regularly replenished with recently manufactured supply.

requirement
Affects: Eligible entities; domestic and specified foreign establishments

Require participating entities to implement production of the eligible drug or its API at the direction of the Secretary, in the quantities and under the terms specified in the contract or cooperative agreement.

requirement
Affects: Eligible entities

Require eligible entities to enter an arrangement with the Secretary to (i) transfer a portion of the API reserve to another manufacturer if the Secretary finds additional finished product is needed and the entity cannot use its reserve to meet the need, and (ii) permit the Secretary to direct allocation of the API reserve during a public health emergency, natural disaster, or chemical, biological, radiological, or nuclear threat.

requirement
Affects: Eligible entities; other drug manufacturers; Secretary of HHS

Require the Secretary, in coordination with the Commissioner of Food and Drugs, to issue guidance not later than 180 days after the date of enactment on: (A) factors for determining which drugs/APIs have vulnerable supply chains and how agreements would reduce vulnerability; (B) factors for determining entity eligibility (including commitment to quality systems, domestic manufacturing capacity, and surge capacity); and (C) requirements for award recipients (including excess manufacturing capacity, redundancy, and advanced quality systems).

deadline
Affects: Secretary of HHS; Commissioner of Food and Drugs
Subjects
pharmaceuticals
drug supply chain
public health preparedness
manufacturing
procurement
emergency response
Affected Groups
Drug manufacturers and applicants
Healthcare Providers
American consumers
Department of Health and Human Services personnel
+3 more

Sponsors (2)

Amendments

No Amendments

Related Legislation

Impact Analysis

Who is affected and how:

  • Drug manufacturers and contract manufacturers: Will be directly affected as potential awardees; they may receive federal contracts/cooperative agreements to build and hold reserve stocks and may face new operational requirements (storage, rotation, reporting, and production on government direction). This could create revenue opportunities but also add compliance and inventory costs.
  • API suppliers and specialty chemical producers: May be asked to increase or reorient production to meet reserve needs and to allow transfers or allocation of API stockpiles during emergencies; firms that provide upstream inputs could see increased demand and supply-chain prioritization.
  • Hospitals, pharmacies, and health care providers: Stand to benefit from improved medicine availability and lower risk of disruptions; smoother supply during shortages could reduce care delays and emergency rationing.
  • Patients and the general public: Should experience greater resilience in access to critical medicines during shortages or public health emergencies; benefits accrue unevenly depending on which drugs are prioritized.
  • HHS and federal procurement offices: Will take on program design, award management, guidance development, oversight, and reporting duties; administrative burden and contracting workload will increase.

Broader effects and tradeoffs:

  • Supply-chain resilience: The program is designed to reduce reliance on foreign sources for critical drugs/APIs and to expand domestic capacity, improving preparedness for shortages or emergencies.
  • Market incentives: Federal contracts may encourage investment in domestic manufacturing and storage capacity, but mandatory production directions and reserve requirements could raise operating costs for private firms.
  • Fiscal impact: The bill authorizes funding ($500M FY2026), but actual spending depends on subsequent appropriations and program execution; long-term costs depend on contract terms and sustainment plans.
  • Implementation risks: Success depends on clear guidance, appropriate selection of drugs and entities, contracting design that balances public needs with industry participation, and effective oversight to ensure reserves are rotated and usable when needed.

MichigansenatorGary C. Peters
S-2062 · Bill

RAPID Reserve Act

  1. senate
  • house
  • president
  • Updated 4 days ago

    Last progress June 12, 2025 (8 months ago)

    House Votes

    Pending Committee
    June 12, 2025 (8 months ago)

    Referred to the House Committee on Energy and Commerce.

    Senate Votes

    Vote Data Not Available

    Presidential Signature

    Signature Data Not Available
    United StatesHouse Bill 3955HR 3955

    RAPID Reserve Act

    Health
    1. house
    2. senate
    3. president

    Last progress June 12, 2025 (8 months ago)

    Introduced on June 12, 2025 by Angela Craig