Trump picks Heidi Overton to lead FDA after Makary exit
Heidi Overton, a White House health-policy adviser, has been nominated by President Donald Trump to lead the FDA. She succeeds Marty Makary, who resigned in May amid policy clashes. Overton faces confirmation scrutiny regarding vaccine policy changes while leading an agency recovering from major staff cuts.

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President Donald Trump has selected White House health-policy adviser Heidi Overton as his nominee to lead the Food and Drug Administration. Bloomberg first reported the selection late Tuesday, with Reuters sources corroborating the news. If confirmed by the Senate, Overton will take over an agency that is rebuilding after former Commissioner Marty Makary’s resignation and significant staff reductions.
Overton’s Policy Background
Overton serves as deputy director of the White House Domestic Policy Council, where she has helped vet major health-policy decisions. She previously served as chief policy officer at the America First Policy Institute and vice chair of its Center for a Healthy America. A physician board-certified in public health and general preventive medicine, she trained in surgery and clinical investigation at Johns Hopkins.
Her academic connection overlaps with Makary, who taught surgery and health policy at Johns Hopkins. The pair co-wrote a 2017 BMJ opinion piece arguing that surgeons’ prescribing practices helped fuel the opioid epidemic. Overton had previously emerged on a three-person shortlist for the FDA post.
Agency Rebuilding Efforts
If confirmed, Overton would inherit an FDA that has lost more than 3,000 employees and division leaders over the past year. Officials stated in June that the agency was hiring about 2,200 people after the cuts disrupted regulatory deadlines and drug reviews.
Makary resigned in May after 13 months at the FDA following clashes with White House and health officials over drug, vaccine, and vaping policy. Days after his exit, acting drug-center chief Tracy Beth Hoeg was also forced out. Since then, acting Commissioner Kyle Diamantas has reopened regulatory paths for several rare-disease therapies, including a reconsideration of Regenxbio’s gene therapy.
Vaccine Policy Scrutiny
Overton appeared at a White House event last week as Trump announced changes to the childhood vaccine schedule. This issue is likely to draw scrutiny during her confirmation process. The policy shift had already sparked debate over the administration’s vaccine agenda. Benzinga reached out to the White House and the FDA for comment but did not receive an immediate response.
How might Heidi Overton's background in public health and her previous work on opioid prescribing practices influence the FDA's regulatory approach to pharmaceutical marketing and safety monitoring?
What specific timeline can investors expect for the FDA to restore its full staffing levels, and how will this hiring process impact the speed of upcoming drug and device approvals?
Will the proposed changes to the childhood vaccine schedule lead to stricter FDA oversight requirements for vaccine manufacturers or alter the agency's stance on post-market surveillance?

























