Trump Set to Nominate Dr. Heidi Overton for FDA Commissioner, Filling Post Vacant Since Makary's May Exit

President Trump is expected to nominate Dr. Heidi Overton as the next FDA commissioner, according to CNN and Bloomberg News, both citing people familiar with the decision. As of this writing, the White House has not officially announced the nomination.

Overton currently serves as deputy director of the White House Domestic Policy Council. She holds a medical degree from the University of New Mexico, completed a general surgery residency at Johns Hopkins, and earned a PhD in clinical investigation from Hopkins' Bloomberg School of Public Health. Before joining the White House, she was chief policy officer and vice chair for the Center for a Healthy America at the America First Policy Institute, a conservative think tank.

The job has sat unsettled since Dr. Marty Makary resigned as FDA commissioner in May, CNN reported, describing his exit as coming "amid intense pressure from the White House." Since then, Kyle Diamantas, the agency's deputy commissioner for food, has run the FDA in an acting capacity. CNN reported Diamantas repeatedly turned down the top job, even when Trump asked him directly, citing his young children and personal reservations. He's expected to stay at HHS once a new commissioner is confirmed.

Rep. Brad Wenstrup, an Ohio Republican and physician, was reportedly the administration's earlier preferred choice but declined the position, according to CNN.

Overton has been a visible presence at White House health policy rollouts. She stood behind Trump in the Oval Office when he signed an executive order splitting the combined measles-mumps-rubella vaccine into three separate shots, a move biospace noted was "largely panned by pediatric health experts and doctors alike." CNN reported the order drew sharp criticism from GOP Sen. Bill Cassidy and much of the public health establishment. She's also appeared at administration events on drug pricing, peptides, and psychedelic therapies, according to Truist Securities.

Wall Street's early read is cautiously favorable. BMO Capital Markets called the pick "a modest positive," writing that it "removes a leadership overhang and puts a credentialed physician in charge," while adding the real test is "whether she can restore predictability (and credibility) to the drug review process." Truist Securities described the selection as "on-brand," noting Overton is "a face we have noticed at White House podiums for regulatory developments."

If Overton is formally nominated, she'll face a Senate confirmation fight through the health committee. That panel just went through a bruising process with Dr. Erica Schwartz, Trump's pick to run the CDC, whom the Senate narrowly confirmed this month only after Cassidy delayed the vote over his ongoing concerns about the administration's vaccine policies, according to CNN. Expect similar scrutiny here, particularly given Overton's role in shaping the MMR vaccine order and her ties to America First Policy Institute.

Whoever takes over inherits an agency mid-crisis on multiple fronts. The FDA is currently reviewing a Class I recall of Becton Dickinson intraosseous vascular access needle sets tied to 45 serious injuries and four deaths, according to MedPage Today. Separately, the FDA issued an early alert about BD convenience kits containing recalled sodium chloride ampules from Huons Co., warning of possible sterility failures that could trigger systemic inflammatory responses, infections, or organ failure. BD sent affected customers a letter on August 10 recommending that the kits be corrected before continued use, and the FDA says no serious injuries or deaths had been reported from that specific issue as of July 29.

The new commissioner will also need to fill numerous high-level leadership slots that have sat vacant under acting staff. Recent advisory committee meetings on Replimune and Capricor Therapeutics have been flagged as chaotic and as an early test of whether the agency can restore trust with rare disease drug developers and patient groups.

One unresolved policy question looms over any Overton confirmation hearing: whether the FDA will act on calls from conservative advocates, including a recent Daily Wire opinion piece, to formally review mifepristone's safety data and restore in-person dispensing requirements for the abortion pill. The FDA has said for over a year it plans its own review of the drug but has not announced results or a timeline. Overton's confirmation hearing would be a logical venue for senators to press her directly on where that review stands.

No date has been set for a formal nomination announcement or Senate hearing as of this writing.