WASHINGTON (AP) — Dr. Heidi Overton, a top White House aide, has been picked to lead the Food and Drug Administration, President Donald Trump announced Wednesday.
Overton is a medical doctor and deputy director of the White House Domestic Policy Council who has worked on several of Trump’s second-term health initiatives. She has become a trusted administration figure and a champion of the Republican president’s goals.
If confirmed by the Senate, she would have to balance a raft of competing priorities, including Trump’s fixations, the anti-regulatory interests of traditional Republicans and the anti-corporate posture of Health Secretary Robert F. Kennedy Jr.
Those challenges dogged the tenure of the previous FDA head, Dr. Marty Makary. He resigned in May, leaving behind unfinished projects such as work on ultraprocessed foods, antidepressants and COVID-19 shots.
Referring to a “Dr. Heidi” in a Truth Social post, Trump said Overton was a smart and respected “rockstar” who would deliver on his priorities of faster cures, innovation, lower drug prices and more wins for Kennedy’s “Make America Healthy Again” movement.
Kennedy posted on X that Overton has “exceptional judgment, professionalism, discipline and an unwavering commitment to the American people.”
Overton has promoted Trump’s health priorities
Overton attended medical school at the University of New Mexico and has a doctoral degree in clinical investigation from Johns Hopkins University, according to her LinkedIn profile. Before joining Trump’s second administration, she was the chief policy officer at the America First Policy Institute, a conservative think tank.
In recent months, she has appeared with the president to announce major projects, including some of his “most favored nation” deals with drug companies to lower prices to those of other developed countries and his recent vaccine order that sought to split the combined measles, mumps and rubella (MMR) vaccine into three separate immunizations — against the advice of medical groups.
At an Oval Office event to promote that order, she stood by Trump as he falsely suggested the number or timing of vaccines could play a role in rising rates of autism spectrum disorder. Scientific consensus and decades of studies have firmly concluded there is no link.
Overton has been critical of abortion pills and, if confirmed, would be positioned to roll back FDA rules that made them more accessible. U.S. abortion opponents have expressed frustration that the administration has not acted to stem the flow of such pills prescribed online, a situation they view as undermining state abortion bans.
To be confirmed, Overton must approval from a narrowly Republican-led Senate and face questions from the Senate Health, Education, Labor and Pensions Committee. Its chair, Republican Sen. Bill Cassidy, a physician from Louisiana, has been a vocal critic of some of Trump’s actions to sow doubt in vaccinations, including the MMR order.
Democratic senators slammed the nomination.
"Heidi Overton is a far-right, anti-abortion extremist who has no business leading the FDA," Washington Sen. Patty Murray, a committee member, posted on social media.
Makary’s replacement will face challenges he left behind
Before he left the FDA, Makary had drawn complaints from health industry executives and anti-abortion activists. But the frustration with him came to a head over the agency’s lack of movement on flavored e-cigarettes. Companies such as R.J. Reynolds are seeking to market to adult smokers, but sweet-flavored vapes have long been blamed for the trend of teenage vaping. FDA scientists have hesitated to endorse those products to curb adult smoking.
Days before Makary's departure, the agency opened the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, in a policy change that essentially bypassed FDA staff experts.
Pharmaceutical companies will be looking for changes at the agency, too, after rejections or reversals of biotech drugs intended for rare diseases. Complaints from biotech companies, investors and patient groups have grown and been taken up by conservative lawmakers.
Makary tried to assuage industry grievances, in part by announcing new programs designed to streamline or accelerate drug approvals. Some of those initiatives, however, have meant new headaches for the agency.
Several of Makary’s deputies also exited the agency.
Dr. Vinay Prasad, the vaccine and biotech chief, stepped down in April following intense criticism from drugmakers, patients and investors. Dr. Tracy Beth Hoeg, who was involved in scrutinizing the safety of antidepressants, COVID-19 vaccines and other widely used therapies, was replaced as FDA’s acting drug center director.
MAHA has high expectations of next FDA head
Overton would also need to tend to the priorities of Kennedy’s health movement.
One major decision for the next commissioner is what to do about peptide regulation. A panel of federal health advisers selected by Kennedy recently recommended easing access to several peptides that are popular with wellness influencers and celebrities, despite warnings from FDA scientists that the chemicals have not been shown to be safe or effective.
The agency recently proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods. But the agency is still working with the White House to finalize a first-of-its-kind definition of ultraprocessed foods, which Kennedy blames for elevated rates of diabetes, obesity and other chronic conditions.
Under Kennedy, the FDA has set up extra hurdles for vaccine testing and blocked the publication of research into the effectiveness of COVID-19 shots. Kennedy stood by Trump recently as the president signed the executive order aimed at upending childhood vaccinations in the U.S. despite unprecedented financial and logistical challenges.
The FDA also has an ongoing review of widely used antidepressants, including whether they may increase the risk of autism and other disorders when used during pregnancy. The medicines have long been a target of Kennedy, who was a leader in the anti-vaccine movement before joining the government.
In recent weeks, the agency has been investigating two summertime foodborne illness outbreaks: a cyclospora outbreak linked to tainted iceberg lettuce that has sickened thousands of people and a multistate salmonella outbreak linked to jalapeño peppers.
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Swenson reported from New York.
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