On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as Secretary Kennedy and the Food and Drug Commissioner Dr. Makary have started to testify before Congress on the FY26 budget and the House and Senate Appropriations Committees are moving forward with their annual appropriations work. Further still, the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is scheduled to markup their FY26 Ag-FDA Approps bill later this week.
Here are five takeaways from the recently released Food and Drug Administration (FDA) FY26 Justification for Appropriations Committees (the Congressional Justification):
- Relatively stable funding: The FY26 budget provides $6.8 billion for FDA, which is an overall decrease of $271 million (3.9%) compared the enacted FY25 level.
- Ensures user fee continuity: Under the FY26 budget, funding for FDA would continue to be a combination of $3.2 billion in discretionary budget authority (a decrease of 11.4%) and $3.6 billion in user fees (a 4% increase). Continuity of user fee funding for medical devices is specifically called out with an increase of $118.2 million to “sustain medical device review and research” and the budget also affirms the importance of the agency being funded by both user fees and discretionary resources, highlighting the importance of this balance in predictable pre-market review of medical products.
- Advancing MAHA: The administration’s “Make America Healthy Again” (MAHA) policy agenda is prioritized and related areas of focus are prominently featured throughout FDA’s budget materials, including an increase of $234.6 million to “address the nation’s chronic disease epidemic, restore public trust in our food system, and strengthen our nation’s nutritional and food safety.” The FY26 budget highlights continued work related to phasing out certain dyes from the food supply and efforts to modernize the Substances Generally Recognized as Safe (GRAS) pathway through potential future rulemaking.
- More details on “DOGE” impact and efforts to streamline: Questions remain regarding the impact of the agency’s reduction in force (RIF) earlier this year and the budget materials provide further insight into the agency’s total workforce assumptions going forward: the FY26 budget document repeatedly notes that the budget “reflects a decrease of 1,940 FTEs and $456.6 million in budget authority in support of the Reduction of Federal Bureaucracy initiative.” The FY26 budget seeks to build on the efforts underway to consolidate core functions and gain efficiencies and envisions a reduction of $626 million due to streamlining functions across the agency.
- More to come: The annual release of the President’s budget is a key step in the process by which FDA is funded but it is not the last. Congress has already begun the FY26 appropriations process, which will continue to play out in the coming weeks and months as the House and Senate dive into the latest details provided by the administration and work through the appropriations process ahead of the end of the current fiscal year (September 30, 2025).