FDA Submits Its 2025 Funding Allocation Request

On March 11, the U.S. Food and Drug Administration (FDA) revealed it was requesting a 7.4% increase over its 2023 funding level as part of the President’s proposed 2025 budget. The funds, according to a release put out by FDA, would be used to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities.
 
“The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “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. The budget will also support the FDA’s ability to prepare for, build resilience to, and respond to shortages, support the implementation of expanded cosmetics regulation, and protect and promote a safe, nutritious U.S. food supply.”
 
The highlights of the request most relevant to medical device manufacturers are focused on funding to address supply-chain disruptions and enhance resiliency ($12.3M). The agency’s announcement also highlights dedicated funds to support its public health employee workforce, citing the need to cover inflationary pay costs and cost-of-living adjustments to minimize reductions to hiring capabilities ($114.8M). In addition, monies would be earmarked for supporting modernization activities ($2M), building of the agency’s centralized enterprise date-modernization capabilities ($8.3M), and ensuring optimal functioning of the FDA’s offices and labs ($43.6M).
 
The agency’s fiscal period runs from October 1, 2024 through September 30, 2025.