Makary Out at FDA After 13 Months of Turmoil

Makary Out at FDA After 13 Months of Turmoil

Marty Makary has stepped down as Food and Drug Administration commissioner after a turbulent year and a half defined by internal friction, regulatory chaos, and clashes with the Trump administration over core policy questions.

Kyle Diamantas, the FDA's deputy commissioner for food, will serve as acting commissioner, President Trump announced on Truth Social. When asked whether he had fired Makary or pressured him to resign, Trump offered only vague praise: "Marty is a great guy. He was having some difficulty."

Makary, a Johns Hopkins physician and researcher, inherited an agency already reeling from staffing cuts that accompanied the broader health department overhaul orchestrated by Health Secretary Robert F. Kennedy Jr. The FDA's drug center cycled through four different directors in a single year, a sign of the institutional strain rippling through the agency.

His departure opens a third major health position for Trump to fill, alongside vacancies at the Centers for Disease Control and the surgeon general's office.

A Constant Flash Point

Makary faced relentless pressure from multiple directions. Anti-abortion groups demanded his removal for failing to reinstate in-person dispensing requirements for mifepristone and for allowing the FDA to approve a generic version of the abortion pill. Meanwhile, Trump himself had to personally intervene to push Makary to authorize flavored vapes, which the commissioner had initially resisted.

Healthcare investors criticized the agency for unpredictable regulatory decisions that rejected several promising drug candidates. The FDA also drew scrutiny for rejecting certain rare disease drugs, decisions tied partly to Vinay Prasad, the biologics division chief who has since left the agency as well.

Still, Makary pursued initiatives aimed at modernizing the FDA's regulatory machinery. He worked to streamline approval processes through real-time clinical trials, established a voucher system to expedite reviews of treatments aligned with administration priorities, and moved to curtail animal testing requirements.

These efforts, however, were repeatedly overshadowed by controversy and what internal critics said was an unwillingness to fully accommodate Trump's policy agenda.

The commissioner entered the role with substantial credibility as a respected physician and researcher, but the combination of depleted staff capacity, competing political pressures, and fundamental disagreements over drug policy made the position untenable in short order.

Trump's next choice for FDA commissioner will carry obvious significance. Finding a nominee who pleases pharmaceutical industry stakeholders while satisfying the demands of Kennedy's Make America Healthy Again movement, which views traditional FDA approvals with suspicion, presents a complex balancing act that may prove difficult to solve.

Author James Rodriguez: "Makary was caught between an industry desperate for predictable rules and a White House that wanted to tear up the rulebook entirely. That's a fight nobody wins."

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