FDA cliffhanger: Makary's fate in limbo
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Makary at a November White House event on lowering drug prices. Photo: Andrew Harnik/Getty Images
The Food and Drug Administration was supposed to be the dull and predictable part of President Trump's health bureaucracy.
- Instead, it's become the soap opera whose cliffhangers leave entire industries in suspense — most recently Friday's drama over reports that commissioner Marty Makary was about to be booted out.
Why it matters: The FDA regulates about one-fifth of the U.S. economy, so organizational disarray, surprise policy moves and political interference can cause real disruption.
State of play: The Johns Hopkins physician and researcher appeared to have been spared late last week after multiple outlets reported that President Trump had authorized his firing.
- Under Makary, there's been considerable drama around abortion pills, flavored vapes, vaccine issues and drugs for rare diseases.
- But he's also made moves to speed up drug approvals and clinical trials and lessen regulatory burdens that will play out in the coming months — whether or not he's around.
The intrigue: Asked about reports of Makary's imminent firing on Friday, Trump replied, "I've been reading about it, but I know nothing about it." The White House didn't respond to questions about Makary's status.
- A White House official told Politico that senior Health and Human Services leaders were pushing for the possible firing, not the White House.
- All of the reports were hedged with the now-standard reminder that Trump often changes his mind. That's something to keep in mind going forward — because there's no guarantee that Makary's apparent survival won't be reversed, either.
- Makary is due to testify on the FDA's 2027 budget at a Senate Appropriations Committee hearing on Wednesday.
What we're watching: If Makary does leave, the expectation is he'll be replaced by a more mainstream figure from inside the FDA.
- Among the internal candidates mentioned is Kyle Diamantas, the deputy commissioner for food.
- There's also speculation Trump could bring back a veteran from his first administration to run the agency. Names that have been floated include former FDA Commissioner Stephen Hahn or Brett Giroir, who was briefly acting commissioner.
- "We expect the White House to nominate a less disruptive, pro-industry commissioner, consistent with other recent steps the administration has taken to moderate the agency," Capstone analyst Will Humphrey wrote late last week in a note.
Between the lines: Big drugmakers and smaller biotechs would welcome more predictability from an agency that's charged with evaluating whether treatments are safe and effective.
- One concern is the workforce that conducts those evaluations, which has been weakened by attrition and brain drain.
- While Makary announced plans this month to hire an additional 3,000 scientists, Raymond James analyst Chris Meekins said hiring data shows staffing at the agency's biologics and drug evaluation centers each down more than 19% since Trump took office, with key vacancies in director and deputy director roles.
There also are a series of high-profile decisions ahead on experimental treatments for cancer and ADHD and rare disease drugs — not to mention Moderna's mRNA flu shot that the agency initially refused to evaluate, before reversing itself.
- "There are also real questions about whether the future FDA leadership will agree with positions this FDA leadership has taken but not yet put into formal guidance," Meekins wrote in a note last week.
The bottom line: Even a leadership shakeup may not immediately resolve concerns about the agency.
