FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
March 11, 2024
Dear International Colleague,
Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency 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 request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health.
“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 FY 2025 request, which covers the period from Oct. 1, 2024, through Sept. 30, 2025, includes new efforts for high-priority program areas. Highlights of the agency’s request include:
Enhancing Food Safety and Nutrition
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$15 million to protect and promote a safe, nutritious U.S. food supply. Funds for the FDA’s human foods initiatives will modernize the FDA’s 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 Chain
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$12.3 million 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. Amongst other initiatives, the agency will hire additional investigators to fulfill inspectional needs associated with increased supply-chain disruptions and consequent human food and medical product shortages in recent years. The agency will also continue promoting manufacturing quality across the pharmaceutical industry and developing and implementing modernized systems to respond to shortages more quickly.
Bolstering Modernization Efforts and Mission Support
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$114.8 million to support public health employee workforce. This funding will 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.
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$8 million in additional funds to support the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). The FDA will use the funding increase to further develop a modernized cosmetics regulatory program and enhance the agency’s efforts to protect consumers and help ensure the safety of cosmetic products. Funds will be used for activities such as developing regulations and compliance policies; managing submission platforms associated with MoCRA provisions; reviewing MoCRA-required information submitted to the FDA for industry compliance; and hiring additional subject matter experts to manage critical projects, such as the assessments of the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
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$2 million increase to support agency modernization activities. The 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 effort to implement common business processes and data optimization across the agency. The budget also proposes new 2-year spending authority to support these critical investments.
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$8.3 million 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 new 2-year spending authority to support these critical investments.
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$1 million to expand foreign offices and strengthen imported products 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
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$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 to evaluate food safety and medical products, 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 the safety and the 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 drugs, medical devices, and 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, and mandatory reporting when certain products test positive for pathogens.
- Support innovation and competition, such as creating a new regulatory category of animal food additives to facilitate marketing of innovative animal food products, as noted in the agency’s Animal and Veterinary Innovation Agenda.
- Facilitate the uptake of biosimilars by updating the U.S. biosimilar program and ensuring it is more consistent with current scientific understanding.
- Encourage meaningful innovation and timely competition for new drugs by amending certain exclusivity provisions.
- Extend 21st Century Cures hiring authority to the FDA tobacco program to most effectively meet its public health mandate.
- Provide additional oversight tools, such as expanding authorities for information-sharing with states, broadening authority to request records or other information in advance of or in lieu of inspections to all FDA-regulated commodities, and requiring importers to destroy products that present a significant public health concern.
- Propose new authorities that would require animal drug sponsors to make post-approval safety changes and expand the FDA’s mandatory recall authority to cover all human and animal drugs.
- Provide the FDA with additional authorities to increase oversight of dietary supplements to better protect consumers from dangerous and otherwise illegal products on the market.
- Modernize the tobacco user fee framework to allow for a fair distribution of tobacco user fee assessments to all regulated tobacco products.
Related Information
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