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FDA Seeks $7.2 billion to enhance food safety and nutrition.
Mar 13, 2024

The US 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 modernise 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.

Robert M. Califf, commissioner, FDA, said, 'The FDA continues to protect the health and well-being of millions of people. This new funding request will help us build on our accomplishments and also modernise 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 US food supply.'

The FY 2025 request, which covers the period from October 1, 2024, through September 30, 2025, includes new efforts for high-priority program areas. Highlights of the agency’s request include:

Enhancing Food Safety and Nutrition

$15 million to protect and promote a safe, nutritious US food supply. Funds for the FDA’s human foods initiatives will modernise 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

$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 fulfil 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 modernised systems to respond to shortages more quickly.

Bolstering Modernisation Efforts and Mission Support

$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 minimise reductions to hiring capabilities and maintain the agency’s highly qualified, specialised staff crucial to carrying out its public health mission.

$8 million in additional funds to support the implementation of the Modernisation of Cosmetics Regulation Act (MoCRA). The FDA will use the funding increase to further develop a modernised 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.

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

$8.3 million to modernise data infrastructure to best support agency operations. Funds will allow the agency to continue building the FDA’s centralised enterprise data-modernisation capabilities and strengthen its common data infrastructure. The budget also proposes new 2-year spending authority to support these critical investments.

$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.

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