Biopharmaceutical executives and investors are cautiously hopeful that President Donald J. Trump’s nominee to head the US Food and Drug Administration will bring some much-needed stability to the agency.
Bloomberg first reported that Trump planned to nominate White House aide Heidi Overton late Tuesday. Trump announced the nomination in a post on his social media platform, Truth Social, on Wednesday. He called her a “ROCKSTAR,” adding, “She is SMART and RESPECTED by all!”
Overton is a physician and senior health policy official on the White House Domestic Policy Council. She has worked with Trump and his allies since 2019; she was a White House fellow in the first Trump administration and spent the Joe Biden years at the Trump-aligned think tank America First Policy Institute.
In the last year and a half, Overton has built a reputation in Washington for balancing the priorities of Make America Healthy Again (MAHA) leaders—including US Department of Health and Human Services secretary Robert F. Kennedy Jr.—with legal and regulatory risks. She reportedly pared down a White House executive order on psychedelic drugs in April, for instance. But she was also involved in drafting the February 2025 executive order establishing the MAHA Commission and in changing the childhood vaccine schedule in January this year, the Atlantic reported. A federal judge blocked the schedule change in March.
Overton will need to be confirmed by the Senate before she can take on the role of FDA commissioner. If she passes muster with the Senate, biopharma executives and investors are hoping that Overton will continue the theme of normality that acting FDA commissioner Kyle Diamantas has sought to achieve in the months since former commissioner Marty Makary resigned.
“The interim acting guy seems to have stabilized the agency after, let’s be generous and say, a rocky period with the prior group,” says Les Funtleyder, a health investor at E Squared Capital Management, a family office in New York. “The concern, I guess, would be the backsliding to what we had prior to the interim, where it seemed like political considerations were more important than scientific.”
A spokesperson for the trade group Biotechnology Innovation Organization (BIO) agrees. “In the past few months, interim FDA leaders have demonstrated excellent governance and have done important work to stabilize the agency and meet the needs of patients,” the spokesperson says. “Our hope is that a new commissioner will continue in this direction and further strengthen the FDA.”
During Makary’s tenure, biopharma leaders complained of mixed signals and shifting processes. The agency at one point refused to review a messenger RNA–based flu shot made by Moderna, then backtracked only a week later. The shot was ultimately approved under Diamantis this month. At another point, Makary’s FDA surprised executives at the rare-disease drug developer UniQure by asking for more clinical research on a Huntington’s disease drug, about-facing on a decision to review the drug candidate based on a Phase 1/2 trial. UniQure now plans to seek FDA approval this year.
Makary resigned in April. Around the same time, the heads of the Center for Drug Evaluation and Research (CDER), which oversees small molecules, and the Center for Biologics Research and Evaluation (CBER), which oversees biologics and vaccines, left the agency as well. Both arms are currently led by acting directors. If confirmed, Overton will be responsible for appointing permanent leaders.
How an Overton FDA would operate will “depend on who leads CDER/CBER and how she works with them,” Daphne Zohar, founder and CEO of Seaport Therapeutics, says in an email to C&EN. “Her lighter regulatory record could mean FDA keeps more day-to-day autonomy (good for stability, similar to Diamantas), but concerns would be if she is political and especially if she takes too many cues from [Kennedy].”
CBER has considerable influence over the US vaccine schedule, since it is responsible for approving new vaccines and could suspend existing vaccines in the event of serious safety issues. Overton herself has toed the White House line on vaccine recommendations in recent weeks, encouraging states to adopt a list of recommendations, including one to separate the measles, mumps, and rubella (MMR) vaccine into three separate shots.
The vaccines were historically administered separately but were combined for ease of access once physicians learned there were no safety issues with coadministration. No US manufacturers currently make separate measles, mumps, or rubella shots.
“We do still recommend the measles vaccine for all children, but we want parents to be informed about the timing and have the option to separate them out,” Overton said during a press conference about the recommendations on Aug. 10.
