FDA Budget Proposal Details $400 Million in Cuts

A just-released FDA FY 2026 budget proposal shows that beginning 10/1 the agency’s overall budget would decrease by 4% ($271 million) to $6.8 billion. This includes $3.2 billion, an 11% or $400 million cut, in discretionary budget authority, and $3.6 billion in user fees, an increase of 4.0 percent or $137 million compared to the FY 2025 enacted budget. An increase in industry-paid user fees comes as a surprise after earlier statements from HHS secretary Robert F. Kennedy Jr. questioned their legitimacy, criticized the agency’s focus on treatments over cures, and portrayed the agency as overly influenced by the industries it regulates.

During a 5/20 Senate Appropriations Committee hearing, FDA commissioner Marty Makary took some heat from lawmakers over the Trump administration’s secrecy about the unreleased proposal at the time (see earlier story). Senator Patty Murray (D-WA) voiced concern over the budget and said that appropriators “cannot cheap out on the FDA and expect to maintain that gold standard... You are now testifying that the budget proposes to slash FDA by more than 11%, and that’s actually news to all of us, and I'll tell you right now, it is not going to fly. It’s reckless, and it’s not going to happen, as long as I have anything to say about it.”

As expected under the proposal, Kennedy’s Make America Healthy Again initiative will see a large boost ($235 million) in FDA funding “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 proposal says. “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. This investment will ensure the safety of the U.S. food supply, invest in nutrition, prevent food safety failures, prevent infant formula contamination and shortages, and restore laboratory operations to conduct gold standard science.”

One of the largest cuts in the budget is related to ongoing reduction-in-force efforts that the proposal lumps under “Promoting efficiency through Consolidation of Core Functions” ($626 million reduction), which it describes as “streamlining functions across the agency to save taxpayers money while preserving core services.” This includes a $169.4 million reduction related to executive orders directing U.S. government-wide contract and spending efficiency initiatives, and a $456.6 million cut related to 1,940 employees laid off under the Department of Government Efficiency (DOGE) initiatives.

Other notable budget highlights include:

• 21st Century Cures would be cut $50 million due to end of the authorized funding from the 21st Century Cures Act
• Infrastructure, Facilities Investments and Rent would lose $87.1 million under DOGE-recommended cuts. The proposal says FDA continues to assess its infrastructure requirements to ensure alignment to the administration’s goals.
• Human drugs program would lose $41.7 million through contract and spending efficiencies, which includes $20.8 million at CDER, $20.7 million at FDA’s Office of Inspection and Investigations (OII), and $230,000 at the agency’s Field Laboratory Operations.
• Biologics program would lose $29.6 million through contract and spending efficiencies, including $27.5 million for CBER and $2 million for OII.
• Medical devices program would be cut $25.8 million under contract and spending efficiencies, including $22.2 million at CDRH and $3.6 million for OII.