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White House officials have approved plans to replace Marty Makary as commissioner of the Food and Drug Administration after months of internal turmoil, mounting criticism and a wave of senior staff departures at the agency, according to people familiar with the discussions.
The individuals, who spoke on the condition of anonymity to discuss internal deliberations, said the final decision rests with Donald Trump. Asked Friday about reports that Makary could be removed, Trump distanced himself from the matter.
“I’ve been reading about it, but I know nothing about it,” Trump told reporters.
Makary’s potential departure would mark the latest upheaval inside the Department of Health and Human Services, where administration officials have increasingly replaced allies of Health Secretary Robert F. Kennedy Jr. with more traditional or politically stable choices ahead of the midterm elections.
Officials familiar with the matter said broader structural changes at the FDA are also under consideration after White House and health officials reviewed agency operations and identified what they described as opportunities for greater efficiency. They cautioned, however, that Trump has reversed personnel decisions before public announcements, and plans could still change.
No acting replacement has been finalized, according to the people familiar with the discussions.
The White House declined to directly address Makary’s future Friday. Spokesman Kush Desai instead praised the administration broadly, saying Trump had assembled “the most experienced and talented administration in history.”
The report of Makary’s possible ouster was first published by The Wall Street Journal.
Makary, a surgeon at Johns Hopkins University School of Medicine and former Fox News contributor, was nominated by Trump in late 2024 and confirmed by the Senate in March 2025 with support from three Democrats in a rare bipartisan vote.
Trump at the time praised Makary as a figure capable of restoring confidence in the FDA, arguing the agency had “lost the trust of Americans.”
During his tenure, Makary advanced several initiatives aligned with Kennedy’s “Make America Healthy Again” agenda, including efforts to remove artificial food dyes and tighten oversight of chemicals added to foods without FDA review.
But his leadership also sparked backlash from pharmaceutical companies, public health experts and parts of the medical community. Critics objected to the FDA slowing or rejecting approvals for treatments targeting skin cancer and Huntington’s disease, as well as adopting a tougher framework for vaccine approvals.
Makary defended those decisions this week in an interview with CNBC, dismissing criticism as “corporate spin.”
“If your drug works, it’s going to get approved,” Makary said. “Do you throw science out the window … or do you do what’s right?”
The commissioner also faced pressure from anti-abortion activists and Republican lawmakers seeking tighter restrictions on the abortion pill mifepristone.
His tenure coincided with several other leadership changes inside federal health agencies. Trump last month tapped former deputy surgeon general Erika Schwartz to lead the Centers for Disease Control and Prevention after previously withdrawing other nominees.
The administration also recently elevated health care entrepreneur Chris Klomp as Kennedy’s top deputy at HHS as part of a broader effort to stabilize the department.
Several top FDA positions remain vacant, including the acting heads of the agency’s vaccine and drug divisions. Sara Brenner, who briefly served as acting FDA commissioner after Trump took office, is transitioning to a senior counselor role at HHS.
Makary’s possible removal comes as administration officials seek to soften public focus on controversial vaccine policy changes ahead of the midterms while emphasizing initiatives tied to food safety and prescription drug prices. Republican strategists have reportedly warned the White House that vaccine skepticism could become politically damaging.
