Trump picks Dr. Heidi Overton, a top White House aide, to lead the Food and Drug Administration

Those challenges dogged the tenure of the previous FDA head, Dr. Marty Makary, who resigned in May, leaving behind unfinished projects including work on ultraprocessed foods, antidepressants and COVID-19 shots.

Referring to a “Dr. Heidi” in a Truth Social post, Trump called Overton 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.

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 served as chief policy officer at the conservative think tank America First Policy Institute.

In recent months, she has appeared with the president to unveil 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 controversial vaccine order, which sought to split the combined measles, mumps and rubella, or MMR, vaccine into three separate immunizations against the advice of medical groups.

At an Oval Office event to promote that order, she stood by the president as he falsely suggested the number or timing of vaccines could play a role in rising rates of autism spectrum disorder, even as 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 the pills more accessible. U.S. abortion opponents have expressed frustration that the administration hasn’t moved to stem the flow of abortion pills prescribed online, a situation they view as undermining state abortion bans.

To get confirmed, Overton will have to win approval from a narrowly Republican-led Senate and face questions from the Senate health 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 his recent order.

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 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 teen vaping, and FDA scientists have hesitated to endorse them to curb adult smoking.

Days before Makary left, the agency opened the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, a policy change that essentially bypassed agency staff experts.

Pharmaceutical companies will also be looking for changes at the agency, following rejections or reversals of biotech drugs intended for rare diseases. Complaints from biotech companies, investors and patient groups have grown and have been taken up by conservative lawmakers.

Makary attempted to assuage industry grievances, in part by announcing new programs designed to streamline or accelerate drug approvals. But some of those initiatives have created new headaches for the agency.

Several of Makary’s deputies also exited the agency. Dr. Vinay Prasad, the agency’s vaccine and biotech chief, stepped down in April following intense criticism from drugmakers, patients and investors. And 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

Makary’s replacement will also need to tend to the priorities of Kennedy’s Make America Healthy Again 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 popular with wellness influencers and celebrities, despite warnings from FDA scientists that the chemicals haven’t been shown to be safe or effective.

The agency also 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 nationally elevated rates of diabetes, obesity and other chronic conditions.

Under Kennedy, the FDA has also set up extra hurdles for vaccine testing and blocked the publication of research into the effectiveness of COVID-19 shots. And 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.

The agency has also been investigating two summertime foodborne illness outbreaks: a cyclospora outbreak linked to tainted iceberg lettuce that has sickened thousands of people and jalapeño peppers linked to a multistate salmonella outbreak.

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AP Health Writer Matthew Perrone contributed to this report.

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