Bills of Congress June 12, 2025 by U.S. Congress

H.R.3955 - Rolling Active Pharmaceutical Ingredient and Drug Reserve Act; RAPID Reserve Act (119th Congress)

Summary

H.R. 3955, the RAPID Reserve Act, aims to bolster the supply chain resilience of critical drugs and active pharmaceutical ingredients (APIs). It directs the Secretary of Health and Human Services (HHS) to award contracts or cooperative agreements to eligible entities for maintaining reserves of these critical drugs and APIs. The goal is to prevent supply disruptions during drug shortages or public health emergencies.

The bill mandates that these entities maintain a 6-month reserve, regularly replenished, and implement production at the Secretary's direction. It also includes provisions for transferring API reserves to other manufacturers if needed and allows the Secretary to direct allocation during emergencies.

Furthermore, the bill prioritizes domestic manufacturing and sourcing from OECD countries, and it authorizes $500 million in appropriations for fiscal year 2026 to carry out these provisions.

Expected Effects

The RAPID Reserve Act is likely to create a more stable supply of critical drugs and APIs, reducing the risk of shortages during public health crises. It could also stimulate domestic manufacturing of pharmaceuticals and related materials. The Act will also likely increase costs associated with pharmaceutical products as manufacturers seek to recoup costs associated with maintaining the reserves.

This bill will also require the Secretary of HHS to develop guidance on identifying vulnerable supply chains and determining eligibility for participation in the program. This guidance will be crucial in shaping the program's effectiveness and impact.

Finally, the bill will require the Secretary of HHS to submit reports to Congress detailing the list of eligible drugs and the effectiveness of the program.

Potential Benefits 4/5

- Reduced risk of drug shortages, especially during public health emergencies.
- Increased domestic manufacturing capacity for critical drugs and APIs.
- Enhanced supply chain resilience, making the US less vulnerable to disruptions.
- Potential for job creation in the pharmaceutical manufacturing sector.
- Improved access to essential medicines for patients.

Most Benefited Areas:

Public Health & Healthcare Access ★ ★ ★ ★ ★

Individual Liberties, Rights & Privacy ★ ★ ★ ★ ★

Religious Freedom & Expression ★ ★ ★ ★ ★

Potential Disadvantages

- Potential increase in drug costs due to the expense of maintaining reserves.
- Possible administrative burden and complexity in managing the reserve program.
- Risk of selecting the wrong drugs for the reserve, leading to wasted resources.
- Dependence on the Secretary's ability to accurately identify vulnerable supply chains.
- Limited scope, as the bill focuses only on specific 'eligible' drugs.

Constitutional Alignment 4/5

The bill appears to align with the Constitution's Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce, including the production and distribution of drugs. The Act also aligns with the General Welfare Clause (Article I, Section 8), as it aims to promote the health and well-being of the population by ensuring access to critical medications.

There are no apparent infringements on individual liberties or rights as defined by the Bill of Rights. The Act focuses on regulating commercial activity related to pharmaceuticals.

However, the broad delegation of authority to the Secretary of HHS could raise concerns about the non-delegation doctrine, which requires Congress to provide clear standards for executive action. However, the bill does provide some guidance, which may be sufficient to satisfy this doctrine.