Makary Takes Heat for Budget, Mass Firings at Hearing
FDA commissioner Marty Makary was pressed by lawmakers during a Senate appropriations hearing over the Trump administration’s secrecy about the agency’s fiscal year 2026 budget proposal, which calls for a $400 million (11.5%) cut in budget authority, and the instability at the agency caused by an over 4,000 reduction in employees this year.
In his opening remarks, Makary said that since being confirmed as FDA commissioner he has 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.”
Patty Murray (D-WA) voiced concern over the budget proposal and said that appropriators “cannot cheap out on the FDA and expect to maintain that gold standard... Drug approvals are already getting delayed. Food and drug safety inspections are lagging behind. We are going in the wrong direction fast. We still have yet to see from you a full budget request, and that is unacceptable. 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.”
Senate Appropriation Subcommittee ranking member Jeanne Shaheen (D-NH) said in opening remarks that she feared FDA’s core mission is at risk because of the Trump administration’s action. “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’s important to keep and who is not critical to the mission,” she said. “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.”
During questioning, committee chair Susan Collins (R-ME) noted that the recent staffing cuts appear to have affected the balance between innovation and regulatory review. She said she is concerned about the downstream impact of delays to patients suffering from debilitating rare diseases. She asked what FDA will now do to accelerate getting new treatments for rare diseases to patients safely and as soon as possible?
In response, Makary said the agency needs to customize the regulatory process to the condition being treated. For rare conditions, “we have to drop our randomized control trial requirements,” he said. Regarding approval schedules, he said there have been no staffing changes that have affected these. “We are on track to meet all of our PDUFA targets.” He said there are instances every year where career scientists ask for more review time, either to convene an advisory committee to weigh in, or to design a very unique, specific randomized trial early in the development phase.
Collins told Makary that she is hearing something entirely different, particularly reports about the disarray occurring at CBER after former director Peter Marks was forced out. Makary defended the move and called the new director, Vinay Prasad, a scientific genius. “So, I reject the idea that there’s only one scientist in the world that can run CBER well,” he told the senator. The 42-year-old Prasad “brings a fresh new perspective, and it will not change our approach to rare diseases or the predictability that people need in the market,” he said.
In closing, Makary told the hearing that he is beginning a listening tour. “We’re going to be traveling around the country, myself and some of the other FDA leaders, meeting with industry leaders, developers, inventors, scientists, and academics,” he said. “We want to hear how we can perform better. We don't claim to have all the answers. We don't claim to have the truth on health, but we do have a lot of intellectual curiosity, and we plan when we see something that needs action to take action.”