FDA Requests for a $7.2 Billion Budget in FY 2025 for Critical Health Initiatives

On March 11, the U.S. Food and Drug Administration (FDA) unveiled its request for a $7.2 billion budget as part of the President’s fiscal year (FY) 2025 proposed budget. This funding comprises $3.7 billion from appropriations and approximately $3.5 billion in user fees from companies producing specific products like drugs and medical devices, as well as certain accreditation and certification bodies. With a 7.4% increase, amounting to $495 million above the FY 2023 funding level, the agency plans to reinforce its commitment to public health by focusing on key areas such as food safety, medical product safety, supply chain resilience, and infrastructure modernization.

Following the release of the FDA’s FY 2025 budget request, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra expressed his support for the regulatory agency under the HHS umbrella, pointing out that the FDA has not received sufficient funding as its responsibilities have grown. “We’re not keeping up with funding for the FDA to make sure that we keep pace with all the innovation that’s out there. And so when industries complain that we’re not moving fast enough, we’re bogging down,” said Becerra. 

Related article: HHS Issues Initial Guidance on Negotiation Program as Government’s Latest Move to Reduce Drug Prices 

Priorities and Program Highlights in the FY 2025 Budget Request

According to the FDA’s press release, Commissioner Robert M. Califf, M.D., highlighted the significance of this funding request in sustaining the agency’s pivotal role in safeguarding public health. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent priorities, strengthen our public health capacity, advance IT capabilities, and improve agency-wide infrastructure,” said Dr. Califf.

The FDA’s FY 2025 request, covering October 1, 2024, through September 30, 2025, outlines various high-priority program areas. Notable highlights include an increase of $114.8 million to cover inflationary pay costs for FDA employees and avoid disruptions to hiring capabilities, a funding of $43.6 million for infrastructure and facilities investments to ensure FDA offices and labs nationwide function optimally, a provision of $15 million to enhance the Human Foods Program, focusing on foodborne illness prevention and compliance with food traceability regulations, and $8 million to facilitate the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), focusing on developing a robust regulatory program for consumer safety.

Besides, the budget allocates specific funds for improving supply chain resilience and preparing for and addressing food and medical product shortages ($12.3 million), advancing IT stabilization and data infrastructure modernization initiatives ($8.3 million), improving FDA’s operational efficiency through modernization activities ($2 million) and expanding FDA’s foreign office presence to facilitate timely inspections of overseas facilities in specific countries ($1 million). 

FDA’s Legislative Proposals and Future Directions

In addition to above-mentioned program-specific allocations, the FY 2025 budget includes multiple legislative proposals to support FDA efforts in protecting consumers and patients. Examples include enhancing supply chain resiliency, supporting innovation and competition, facilitating the uptake of biosimilars by updating the U.S. biosimilar program, improving hiring authority for the FDA tobacco program, providing additional oversight tools for the agency, and granting additional authorities to regulate dietary supplements so as to better protect consumers from dangerous and otherwise illegal products on the market.

Overall, the FDA’s proposed budget for FY 2025 underscores its commitment to protecting public health through targeted investments, modernization efforts, and enhanced oversight measures. With a focus on addressing evolving challenges and advancing key priorities, the agency seeks to strengthen its capacity to meet the growing demands of ensuring the safety and well-being of the American public.

Author

Richard Chau