FDA proposes FY 2026 budget; Makary offers details on staff attrition

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 – an 11.5 percent cut from its current budget authority – with the agency looking to increased efficiency from AI tools and staff consolidation to help it meet its goals, despite fewer resources.

FDA Commissioner Martin Makary testified about the budget request before a Senate Appropriations subcommittee on Thursday, where he also faced questions from senators about the agency’s recent actions and staff cuts. Makary said the agency is requesting $6.8 billion in total budget, with $3.2 billion from congressional appropriations and $3.6 billion in user fees, compared to its current budget authority of $3.6 billion in FY 2025 under the full-year continuing resolution passed in March. (RELATED: Firing of FDA probationary staff creates widespread uncertainty, Regulatory Focus 17 February 2025; Thousands of FDA staff fired in latest RIF, Regulatory Focus 1 April 2025)

The hearing was marked by multiple heated exchanges between committee members and Makary concerning the reduction in force, the agency’s new COVID-19 vaccine framework, and the handling of the budget request itself.

In his opening remarks, Subcommittee Chair John Hoeven (R-ND) stressed that Makary’s primary responsibility at FDA is to ensure the safety of the US food and drug supply, despite the administration’s effort to “find savings to address the deficit.”

Subcommittee Ranking Member Jeanne Shaheen (D-NH) followed up by emphasizing the importance of federal investment, stability, and predictability for biomedical product development.

“I fear that the very mission of the FDA is at risk because of the actions of this administration,” Shaheen said. “More than 4,000 people have been pushed out of FDA since January, the majority of those targeted by probationary terminations and reductions in force that don’t seem to have any real analysis of who is important to keep and who is not critical to the mission.”

She added that, “To date, this committee has not received key information on where, specifically, these workforce cuts are happening across centers and offices at the FDA, and that’s information that we need as we’re going to write this budget.”

Shaheen and Committee Vice Chair Patty Murray (D-WA) both expressed frustration with the Trump Administration for not providing the full budget request to committee members prior to the hearing.

“That is unacceptable. You are now testifying that the budget proposes to slash FDA by more than 11 percent. That’s actually news to all of us and I’ll tell you right now, it is not going to fly,” Murray said.

Speaking to the budget request, Makary said the funding will allow the agency to support the Make America Health Again [MAHA] agenda championed by Health and Human Services Secretary Robert F. Kennedy Jr. and touted some of the agency’s recent actions.

“Now, I’ve been at the FDA for about seven weeks, and I’m proud of the early progress we’ve made: working to remove all nine petroleum-based food dyes from the US food supply, eliminating unnecessary animal testing requirements for drugs, we approved a new blood test for Alzheimer’s which could help enable more early treatment,” Makary said.

Makary also derided the agency’s practice of conducting preannounced foreign inspections, saying “they’re a joke,” and that the agency will be implementing “surprise inspections” of those facilities in the future. (RELATED: FDA to expand unannounced foreign inspections after Trump executive order, Regulatory Focus 6 May 2025)

“I’m amazed at some of the stuff that I’m learning when I look under the hood,” Makary added.

Makary stressed multiple times throughout the hearing that “the trains are running on time at the FDA” in response to questions from senators about reports of delayed drug approvals and inspections.

“There have been no staffing changes that have changed any approval schedules. We are on track to meet all of our PDUFA targets,” he said.

When pushed to provide details on recent staff cuts at the agency, Makary refuted the claim that scientific reviewers and inspectors were affected and said the cuts mainly affected administrative positions in human resources (HR), contracts and budgeting, communications, and travel logistics.

“There have about nearly 1,900 people involved in the reduction in force, roughly another 1,200 plus involved in the early retirement package – we are hiring scientists to replace scientists that may have left for an early retirement – but no scientific reviewer or inspector was cut as a part of the reduction in force,” Makary said.

He then emphasized that FDA’s staff has roughly doubled over the last two decades. “That is how we get 2,600 HR people, contracts and budget people, at the agency … 380 communications positions. We’re now down to about 160 – they’re doing a good job – 160 people, that covers a lot of the communication work. Did we need 125 travel coordinators and travel offices in each center, or 13 strategy offices at the FDA?”

Makary also addressed the recent departure of long-time Center for Biologics Evaluation and Research (CBER) Director Peter Marks, who resigned from his position due to conflicts with Kennedy, and his replacement, hematologist/oncologist Vinay Prasad. (RELATED: Marks resigns, blames Kennedy for spreading ‘misinformation and lies’, Regulatory Focus 31 March 2025)

“The scientist replacing Peter Marks is outstanding and I would say take a close look at his credentials … he’s a scientific genius, so I reject the idea that there’s only one scientist in the world that can run CBER well,” Makary said.

“I think we need fresh, new ideas, the new scientist replacing Peter Marks is 42 years old. He brings a fresh, new perspective and it will not change our approach to rare diseases or the predictability that people need … to continue to invest in those technologies.”

“I don’t think it’s careful leadership when you mass fire one in five people across FDA, only to frantically then bring some back because you didn’t stop and think two seconds about whether those jobs were actually important. We really … cannot cheap out on the FDA and expect to maintain that gold standard,” Murray said.

FDA proposes FY 2026 budget; Makary offers details on staff attrition

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