The FDA's high-stakes hiring spree
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Finding a new commissioner is only the beginning of what the Trump administration needs to do to rebuild the Food and Drug Administration — and none of it is easy.
Why it matters: More than a year of upheaval has left the agency's leadership decimated and its reputation for predictable, evidence-based decisions damaged.
- That's as China is threatening U.S. dominance in biopharma, the drug development pipeline is full of promising treatments and the rise of AI poses unprecedented regulatory questions.
The big picture: Former commissioner Marty Makary's departure from the agency was accompanied by a wave of additional exits and staff shakeups, including the removal of the heads of both the drugs and biologics arms of the agency from their positions.
- Dozens of other leadership roles within the agency had been unfilled or lacking a permanent director prior to Makary's departure, according to a recent Raymond James analyst tally.
- Concerns about brain drain have persisted for the vast majority of Trump's second presidency, fueled by DOGE cuts and the voluntary departure of other agency veterans.
- "Makary oversaw what must be the most damaging period in FDA history, given its losses in manpower, experience, and agency capabilities," Capital Alpha's Rob Smith wrote in a note on his departure.
Between the lines: A fresh start at the commissioner level could bring some top talent back and attract new recruits — if the right candidate passes muster with Health Secretary Robert F. Kennedy Jr. and can be confirmed by the Senate.
- "The loss of talent at the agency has been profound," said former commissioner David Kessler. "People are willing to come back, but they're going to have to be assured there's stability."
- "To be able to tackle these hard regulatory questions, you need people who are real experts," he added.
- Part of the administration's sell to high-value candidates is the new leadership structure put in place over the past few months, with chief counselor Chris Klomp running the day-to-day operations of the department, a senior Health and Human Services official said.
- That could help convince candidates worried about working under Kennedy.
Yes, but: Confirming a nominee could be very difficult, especially after Senate health committee Chair Bill Cassidy (R-La.) — a physician increasingly at odds with Kennedy on matters like vaccines — lost his primary to a Trump-backed challenger.
- And, of course, that person has to want the job.
- Brett Giroir, a well-regarded senior health official in the first Trump administration, took himself out of the running earlier this week amid speculation that he was a leading contender for it.
The other side: The commissioner's job could be attractive if the person is given the latitude to run the agency, and former career staff still loyal to the agency can be drawn back in, one former senior FDA official said.
- After all of the headaches over the past year, the White House has good reason to select a quality candidate and let the person do the job, the former official said.
- The selection of acting commissioner Kyle Diamantas has been largely well-received.
What they're saying: "The Trump administration is actively searching for strong candidates for key leadership positions across HHS, including the FDA, with a focus on experienced individuals who can strengthen agency operations, continue to advance significant reforms, and maintain public trust," HHS spokesperson Andrew Nixon said.
The bottom line: The Trump administration will have to convince prospects that they should come work at a demoralized agency that's made headlines for all the wrong reasons.
- If things don't break the right way, U.S. biopharmaceutical leadership could falter.
