A Review of the President’s Fiscal Year 2026 Budget Request for the Food and Drug Administration - Senate Testimony May 22, 2025

Testimony | In Person

• Testimony of: Martin A Makary, M.D., M.P.H. ; Commissioner of Food and Drugs - Food and Drug Administration

May 22, 2025

Chairman Hoeven, Ranking Member Shaheen, and Members of the Subcommittee, thank you for the opportunity to appear before you today to discuss the President’s Fiscal Year 2026 Budget request for the Food and Drug Administration (FDA or the Agency). I would like to start by thanking the Subcommittee for your continued support of FDA. The Agency greatly appreciates the Committee’s sustained commitment to our mission and providing vital resources which have been critical for FDA’s protection of the public health, and we look forward to continuing to work with you to further address critical issues impacting the health and wellbeing of Americans. 

Looking ahead to FY 2026, we will embrace President Trump and Secretary Robert F. Kennedy’s Make America Healthy Again (MAHA) agenda by restoring trust in our food system, prioritizing public health, and strengthening national nutrition and food safety. America is facing an unprecedented chronic disease crisis, with heart disease, diabetes, and obesity affecting millions of lives. Meanwhile, food safety failures, contamination events, and formula shortages have exposed systemic weaknesses in our food and nutrition infrastructure. The FY 2026 budget directly supports the MAHA agenda by ensuring safety of the United States food supply, investing in nutrition, preventing food safety failures and infant formula contamination and shortages, and ensuring appropriations needed to meet certain spending triggers for user fee programs. 

In my first 6 weeks or so at FDA, I have worked to make sure the reviewers and inspectors have what they need to help protect the public health of the American people. FDA will not go through a significant reorganization, we will be centralizing and streamlining shared functions that were previously duplicated throughout the centers and offices, such as IT, communications, and operations. In addition, we are exploring and moving to quickly implement where AI and novel technology can help reduce workload as a tool for the expert scientists and inspectors at the FDA. The initial response from the review staff has been very positive, and I look forward to building on this experience and expanding it throughout the centers at FDA.

The funding requested in the President’s FY 2026 Budget includes critical elements to safeguard public health and the food supply for the American people. Our FY 2026 budget requests $6.8 billion, including $3.2 billion in budget authority and $3.6 billion in user fees. This includes an 11.5% reduction in budget authority compared to the current fiscal year, improving efficiency while still increasing investments in areas that are critical for the American people.

I. Make America Healthy Again

FDA serves a critical role in supporting the Administration’s extensive efforts to protect the food supply, protect against chronic disease, remove any dangerous chemicals and additives from foods, and address any shortages of critical foods such as infant formula.

FDA is committed to radical transparency to give Americans the latest information about the food ingredients they are eating and their effects – in alignment with both MAHA and FDA’s mission. The Agency is leading efforts to protect the U.S. food supply to combat the growing risks associated with some chemical additives used in food, expand Closer to Zero efforts to reduce toxic elements, such as arsenic, from foods consumed by infants and young children, reduce sodium and added sugars, and provide new forms of nutrition labeling to better inform consumers about the foods they consume.

FDA will also expand a new pilot grant program to help schools transition to safer and healthier foods, as well as address failures in inspecting high-risk facilities, strengthen import oversight, reduce foodborne disease outbreak response times, and decrease the number of associated illnesses. This includes supporting advancements in technology to rapidly identify and combat food borne pathogens, such as Salmonella, E. coli, and Listeria. FDA will also continue its commitment to supporting the safety, nutritional quality, and availability of infant formula; maintaining and expanding laboratory capabilities; and supporting cooperative agreements, grants, and contracts in support of federal-state initiatives. FDA and its regulatory partners have a shared mission to ensure the food Americans eat is safe. This mission can only be achieved by fully leveraging resources, expertise, and capabilities as part of an integrated food safety system.

II. Continuity of User Fee Funding for Medical Devices 

FDA’s user fee agreements are negotiated with regulated industry and implemented when Congress authorizes the user fees. Under the Medical Device User Fee Amendments (MDUFA), for FDA to collect and use the medical product user fees, a certain amount of non-user fee appropriations must be appropriated by Congress and spent by FDA on the application review process (known as the “non-user fee spending trigger”). The FY 2026 President’s Budget intends to meet non-user fee spending triggers, including an $8.2 million increase for FDA’s medical device program non-user fee spending trigger and to meet the goals and commitments under MDUFA V.

III. Conclusion 

FDA believes the funding in the FY 2026 President’s Budget will enable the Agency to operate more efficiently, while addressing critical public health and safety priorities, in particular restoring trust in our food system and prioritizing public health. FDA looks forward to working with the Subcommittee to address these critical issues and improve the health and wellbeing of Americans. Once again, I thank the Subcommittee for your continued support, and I look forward to our continued collaboration. I am happy to answer your questions.