The US Food and Drug Administration (FDA) is requesting US$7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding is expected to enhance food safety and nutrition, help support supply chain resiliency, strengthen the agency’s public health capacity and modernize its infrastructure and facilities.

The request also includes an increase of US$495 million — or 7.4% above the FY 2023 funding level. The FDA’s request reflects the agency’s priorities in key areas of importance for human (and animal) health.

Planning for the future
FDA Commissioner Robert M. Califf, MD, says this 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 while protecting and promoting a safe, nutritious US food supply.”

The FY 2025 request covers the period from October 1, 2024, through September 30, 2025, and includes new efforts for high-priority program areas.

Enhancing food and nutrition
US$15 million will go toward protecting and promoting a safe, nutritious US food supply.

Funds for the FDA’s human foods initiatives will modernize its capacity to prevent or mitigate foodborne illness outbreaks by investing in necessary tools and processes to strengthen root-cause investigations.

The budget request also supports the FDA in addressing the enormous public health burden of diet-related chronic diseases and the goals of the President’s National Strategy for Hunger, Nutrition and Health.

Shortages and supply chains
US$12.3 million will be used to address supply-chain disruptions and support supply chain resiliency.

Through an agency-wide crosscutting initiative, the FDA will advance its capabilities to help prepare for, build resilience to and respond to shortages through improved analytics and regulatory approaches.

Bolstering modernization efforts
US$114.8 million will be allotted to support the public health employee workforce and help the FDA cover estimated inflationary pay costs and cost-of-living adjustments to minimize reductions to hiring capabilities and maintain the agency’s highly qualified, specialized staff crucial to carrying out its public health mission.

US$2 million will be used to increase support to agency modernization activities and targeted investments will be used by the FDA to improve the efficiency of its operations by centralizing planning, implementation, and governance of high-priority business process improvement efforts. These include the continuation of the critical inspections platform implementation and expansion efforts to implement common business processes and data optimization across the agency. The budget also proposes a new two-year spending authority to support these investments.

US$8.3 million will be set aside to modernize data infrastructure to best support agency operations. Funds will allow the agency to continue building the FDA’s centralized enterprise data modernization capabilities and strengthen its common data infrastructure. The budget also proposes a new two-year spending authority to support these critical investments.

Also, US$1 million will go toward expanding foreign offices and strengthening imported product oversight. Funding will support the expansion of the agency’s foreign office footprint, expanding agency resources to facilitate timely inspections of foreign facilities in specific countries. Additional deployed personnel would also improve oversight of imported products.

Infrastructure, buildings and facilities
The Biden administration further allots US$43.6 million to ensure optimal functioning of the FDA’s offices and labs. Funding will allow the FDA personnel at facilities across the country to carry out its mission, including evaluating food safety, continue to expand laboratory operations supporting inspections at points of entry to reduce the flow of adulterated and illicit imported products and respond to emergencies. Optimally functioning facilities provide secure, modern, reliable, and cost-effective office and laboratory space that empowers the FDA’s workforce to protect and promote safety and public health.

To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to better support agency efforts to protect American consumers and patients. Notable proposals include efforts to:

• Enhance supply-chain resiliency for foods, including with respect to addressing supply disruptions.
• Provide new authorities to help ensure the safety of foods, including infant formula, medical foods, and foods marketed for infants and young children, which includes new authority to set binding contaminant limits by administrative order, requirements for contaminant testing of final products, more frequent environmental monitoring for pathogens in certain facilities.