FDA Chief Makary Out After Clash With Trump Over Vape Rules

FDA Chief Makary Out After Clash With Trump Over Vape Rules

Marty Makary is stepping down as commissioner of the Food and Drug Administration after 13 months marked by friction with the Trump administration, Congress, and industry groups over contentious regulatory decisions. The resignation came after the president openly criticized the FDA chief for resisting approval of fruit-flavored vaping products.

Kyle Diamantas, who previously headed food policy strategy at the agency, will assume the role of acting commissioner. Trump described Diamantas as a "very talented person" in a Truth Social post confirming the transition.

The departure caps a tumultuous tenure that exposed deep disagreements over agency priorities. Trump had signed off on plans to remove Makary this month following the vape dispute, according to reporting. When asked about the commissioner on Friday, Trump initially deflected, then on Tuesday acknowledged Makary "was having some difficulty" while praising him as "a great guy" and "a great doctor."

Makary had initially blocked approval for the first fruit-flavored vapes on the market, overriding the recommendation of FDA scientists, before reversing course the following week under apparent pressure. The episode highlighted the commissioner's willingness to resist White House pressure on regulatory matters.

His tenure drew criticism from multiple corners. Conservative lawmakers accused him of dragging out a review of mifepristone, the abortion medication, a decision that drew sharp rebukes. Meanwhile, critics worried about vaccine policy decisions, including the FDA's blockade of research on shingles and Covid vaccines and its initial rejection of Moderna's new flu shot, a decision later reversed after public outcry.

Janet Woodcock, former acting FDA commissioner, said the agency demonstrated a "pattern" of "not letting information out that might support the general safety of vaccines."

The broader disruption at the FDA has been extensive. Layoffs and placement of less experienced personnel have created what Peter Lurie, executive director of the Center for Science in the Public Interest and former FDA associate commissioner, described as "endless chaos." Concerns have also emerged over clinical trial guidelines, the commissioner's revamped priority review vouchers, and what critics called "data-free" regulatory decisions.

Republican congressman Darin LaHood said the FDA's "mismanagement and bungled drug reviews" have "chilled investments in life-saving, innovative cures." Republican senator Ron Johnson launched an investigation into FDA rejections of rare disease treatments.

The reaction to Makary's exit split sharply along party lines. Republican senator Josh Hawley called the resignation "welcome news," alleging the commissioner had been "uniquely destructive to the prolife movement" by attempting to place pro-abortion lawyers in key positions and approving a new abortion drug despite data he cited. Hawley framed the departure as a chance for the FDA to "reset."

Senate Democratic whip Dick Durbin offered a starkly different assessment, saying he voted to confirm Makary based on his promise to resist Trump directives that would harm the country. Durbin praised Makary for protecting children from vaping risks and called on other administration officials to show similar spine.

Several high-level health positions remain unfilled. Trump's picks for surgeon general and CDC director have not yet completed Senate confirmation, leaving the National Institutes of Health director temporarily leading the CDC.

Author James Rodriguez: "Makary's exit reveals the impossible position of trying to be an independent-minded regulator in an administration that expects loyalty above science. His replacement will inherit an agency in genuine disarray."

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