On March 28, 2022, the U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget—a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs, and other vital public health infrastructure. The request includes $3.7 billion in budget authority—including an increase of $356 million, and $3 billion in user fees—an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.
“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security, and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” said FDA Commissioner Robert M. Califf, M.D. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas. Highlights of the agency’s request include:
Food Safety & Nutrition Modernization
- $43 million in additional investments in food safety modernization, including animal food safety oversight. The budget builds on the successes of human and animal food safety modernization activities and supports the agency’s continued implementation of the New Era of Smarter Food Safety and other core food safety efforts to enable the FDA to strengthen data-driven approaches to protecting consumers, allocating regulatory oversight resources based on risk and improving the FDA’s capacity to quickly respond to ongoing and evolving public health challenges. Building on the modernized food safety regulatory framework created by the FDA Food Safety Modernization Act, this funding will allow the agency to improve prevention-oriented food safety practices, strengthen data sharing and predictive analytics capabilities and enhance traceability to more quickly respond to outbreaks and recalls for human and animal food. The budget request advances mutual reliance efforts as part of the New Era of Smarter Food Safety by providing significant funding to state animal food programs. In partnership with states, the FDA will expand efforts to modernize, harmonize, and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented.
- $14 million to improve health equity through nutrition. Through the Healthy and Safe Food for All initiative, the budget includes additional funding to reduce exposure to harmful chemicals and toxins in food. Additional funding and legislative proposals will focus specifically on better protecting mothers, infants, and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation.
- $5 million in new funding for a comprehensive strategy for new, alternative methods for product testing. The budget includes funding to support a new, FDA-wide New Alternative Methods Program to reduce animal testing through the development of qualified alternative methods and spur the adoption of methods for regulatory use that can replace, reduce and refine animal testing. New alternative methods have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness.