Five FDA Takeaways from the FY26 Budget

June 2, 2025

Reading Time : 2 min

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):

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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).

Share This Insight

Previous Entries

Eye on FDA

June 20, 2025

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S. national priorities. In terms of qualifying for the program, the key differentiator between this program and other “priority” review programs is that the application must support increased domestic drug manufacturing—presumably meaning that the applicant commits to manufacture the drug in the United States. The key benefit is that drug developers can redeem the vouchers to accelerate their application review time from 10-12 months to one to two months after a sponsor’s final drug application submission. The program includes enhanced communication with the sponsor and will utilize a team-based review process, in which a multidisciplinary team of FDA experts, who will prereview clinical information, gather for a one-day “tumor board style” meeting. While some of the review work is envisioned to be “front loaded” before the actual application is submitted, it is still the case that a two-month review window would be a radical acceleration of the review timeline compared to standard review times.

...

Read More

Eye on FDA

June 16, 2025

Last week, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification (NDIN) review process. Under Section 413 of the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must submit an NDIN to notify FDA before marketing a dietary supplement with a new dietary ingredient. These resources offer guidance on structuring submissions and outline what to expect during the agency’s review. Ultimately, they are intended to enhance the quality of NDIN submissions and minimize common pitfalls, with the goal of avoiding delays or unfavorable results in the agency’s review.

...

Read More

Eye on FDA

June 5, 2025

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory developed tests (LDTs), titled Medical Devices; Laboratory Developed Tests (the LDT Rule). The LDT Rule would have required laboratories to ensure that their offered LDTs met medical device requirements under a multistage phase out of Food and Drug Administration’s (FDA) enforcement discretion policy. While the government’s decision not to appeal this ruling may not have been a surprise, questions remain as to how FDA plans to clarify its policy towards lab test offerings going forward.

...

Read More

Eye on FDA

June 2, 2025

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.

...

Read More

Eye on FDA

May 23, 2025

Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report identifies and focuses on four potential drivers:

...

Read More

Eye on FDA

May 12, 2025

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last month to phase out all petroleum-based synthetic dyes in food by the end of 2026 and transition to natural alternatives (see our post here). Under section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives (unless exempt from batch certification) are subject to FDA approval to determine their safety for use in food. The agency evaluates the safety of color additives based on multiple factors including projected human dietary exposure to the additive, toxicological data, and other relevant information. Once FDA approves a color additive petition, any manufacturer can use the additive in foods for the approved intended uses.

...

Read More

Eye on FDA

May 8, 2025

In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention to use AI to improve regulatory efficiency at HHS and beyond.

...

Read More

Eye on FDA

April 23, 2025

This week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS), announced a series of new measures to phase out all petroleum-based synthetic dyes in food by the end of 2026. This initiative is part of the broader “Make America Healthy Again” (MAHA) agenda aimed at bolstering food safety. Citing growing concerns about the potential role of petroleum-based food dyes in childhood diabetes, obesity, depression and attention-deficit/hyperactivity disorder (ADHD), the agency plans to establish a national standard and timeline for the food industry to transition to natural alternatives.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.