Food and Drug Administration Commissioner Marty Makary is resigning.
Makary notified FDA officials on Tuesday that he plans to submit his resignation to the White House, according to two senior administration officials. Health Secretary Robert F. Kennedy Jr. asked Makary to resign over concerns about his ability to lead the agency, the officials said.
“Bobby is not vitriolic toward Marty,” one official said. “Marty’s just not operating as effectively as he could.”
The embattled top drug regulator had been on “thin ice” with the White House, as NOTUS reported last week. Top administration officials had grown frustrated with his leadership and his unresponsiveness to the White House’s demands, one source familiar with the situation said.
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The officials stressed that Kennedy had pushed for the change.
“This was the secretary’s decision backed by the White House,” a second official said. Some reports had previously indicated HHS chief counselor Chris Klomp had clashed with Makary.
Makary will be replaced by Kyle Diamantas, who currently leads the agency’s Human Foods Program, the officials confirmed to NOTUS. Politico was first to report that Makary is leaving the FDA. Diamantas will serve as acting commissioner until a permanent replacement is nominated.
Makary was previously scheduled to testify before the Senate Appropriations Committee on Wednesday.
Makary and Trump reportedly clashed last week over the FDA commissioner’s reluctance to approve flavored vapes due to concerns about the health risks they might pose to children. The Wall Street Journal reported that Trump pressed Makary to approve more vape flavors in an effort to appeal to MAGA voters.
Last Tuesday, after sources said Makary’s job was in jeopardy, the FDA announced that it was approving four new flavored vape products.
Makary has drawn criticism from the pharmaceutical industry during his time at the agency after he appeared to stonewall the approval and review of drugs, including a Moderna mRNA-based flu vaccine. That decision was later reversed.
Makary had also raised the ire of anti-abortion activists, who have been frustrated with the second Trump administration’s efforts to deprioritize their issue. Makary reportedly slow-walked a promised safety review of mifepristone, a drug used for medication abortion, and last fall, his agency approved a generic version of the drug.
Marjorie Dannenfelser, president of SBA Pro-Life America, a group that supports anti-abortion candidates, had called for his resignation. Dannenfelser confirmed to NOTUS she had a meeting at the White House on Friday she called “very constructive.”
Makary was initially seen as a more traditional pick to lead the FDA, having had a career in surgical oncology. He came to Health and Human Services having gained prominence for critiquing COVID-19 vaccine mandates.
During his time at the FDA, he was known to have a close relationship with Kennedy, Centers for Medicare and Medicaid Services Administrator Mehmet Oz and Jay Bhattacharya, director of the National Institutes of Health.
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