S. 2062: Rolling Active Pharmaceutical Ingredient and Drug Reserve Act

The proposed bill, known as the Rolling Active Pharmaceutical Ingredient and Drug Reserve Act (RAPID Reserve Act), aims to enhance the resilience of the supply chain for critical drug products that are susceptible to shortages. Here’s a breakdown of what the bill entails:

Key Provisions

The bill outlines several key actions to be taken:

• Contracting with Eligible Entities: The Secretary of Health and Human Services (HHS) will award contracts or cooperative agreements to eligible entities. These are organizations that deal with drugs and active pharmaceutical ingredients deemed critical and at risk of supply disruption.
• Maintenance of Reserves: Eligible entities must maintain a reserve of active pharmaceutical ingredients and finished drug products for a period of six months. This reserve is to be carefully managed and regularly replenished to ensure supplies are available during shortages or emergencies.
• Production Management: Participating entities are required to implement production strategies for the eligible drugs and their active ingredients, as directed by the HHS Secretary.
• Transfer of Reserves: If there’s a need for additional finished drug products, entities must agree to transfer a portion of their reserves to other manufacturers as directed by the Secretary.
• Emergency Preparedness: The bill includes provisions for the Secretary to direct the allocation of reserves in case of public health emergencies or natural disasters.

Eligibility and Requirements

To qualify for participation in the program, entities must meet several criteria:

• They must be manufacturers of eligible drugs or active pharmaceutical ingredients or have partnerships with qualified entities.
• Entities must demonstrate a strong commitment to quality manufacturing practices and maintain domestic facilities registered under relevant laws.
• Preference is given to those who can demonstrate domestic sourcing of key materials for drug production.

Guidance and Oversight

Within 180 days of the bill’s enactment, the Secretary, in collaboration with relevant health authorities, is required to provide guidance on:

• The criteria for determining eligible drugs and their supply vulnerabilities.
• The eligibility of entities to participate in the program.
• Contract requirements, including expected manufacturing capacities and quality assurance standards.

Financial Aspects

The bill proposes an authorization of $500 million in appropriations for the fiscal year 2026 to support the implementation of its provisions.

Reporting Requirements

The Secretary must submit reports to Congress every two years detailing:

• The list of drugs identified as eligible and the reasons for their selection.
• Updates on the effectiveness of the program without compromising national security.

Relevant Companies

None found.