President Trump’s nominee to run the Food and Drug Administration is expected to be closely questioned in her Senate confirmation hearing on Thursday about her views on abortion pills, vaccines and highly contested products under F.D.A. review that include A.I. tools and peptide injections.
Dr. Heidi Overton, the nominee, is a top domestic policy adviser at the White House and a former chief policy adviser at a conservative think tank. Her background is far more political than that of previous F.D.A. leaders. She has been a loyal foot soldier to Mr. Trump and Susie Wiles, his chief of staff, according to people familiar with the dynamics who were not authorized to speak publicly.
She would be the first F.D.A. commissioner who has openly opposed use of mifepristone, an abortion pill currently under a safety review by the agency following a push from anti-abortion groups. She has called the drug “dangerous to women” and described the 2022 Supreme Court ruling overturning Roe v. Wade as “a huge victory for life.”
Last month, Dr. Overton stood by Mr. Trump as he signed an executive order calling for fewer childhood vaccinations. She was also a key driver of a plan for federal officials to stop recommending vaccines that protect children from the flu, RSV and meningitis.
The job of running the F.D.A. has always been subject to immense pressure, given billions of dollars that hang in the balance from agency’s regulatory decisions. That pressure has grown during Mr. Trump’s second term, as the administration has forged alliances with backers of tobacco products, artificial intelligence software, cannabis and hemp products, peptides, and an addictive gas-station drug called kratom.
“I think this is a key moment for the integrity of the F.D.A.,” said Dr. Joshua Sharfstein, a former principal deputy commissioner of the F.D.A. and pediatrician. “People are looking to the agency not just because of who is in a particular position, but because of the way the agency does its work. That’s what gives it credibility, and so if that is overridden again and again, then people wonder whether the F.D.A. has integrity in its positions.”
Dr. Overton’s nomination comes amid efforts by abortion opponents and lawsuits filed by conservative states to press the F.D.A. to roll back access to mifepristone. As a result of such dynamics, the F.D.A. has begun its safety review, and a looming test for the agency will be any decisions it makes after concluding that review.
Mifepristone, which was approved by the F.D.A. in 2000, is the first pill taken in the typical two-drug medication abortion regimen. That is now the most common method of terminating pregnancies in the United States.
More than 100 studies have found that mifepristone is safe and that serious complications from taking it are rare. Last fall, under the Trump administration, the F.D.A. granted approval for a new generic version of the medication.
Dr. Overton was the co-author of a 2023 think tank paper that criticized the F.D.A.’s decisions, beginning in 2021, to broaden the availability of abortion pills, especially by removing a requirement that patients obtain mifepristone in person from a medical provider. That decision allowed mifepristone to be prescribed through telemedicine and sent by mail, which has become a major way patients get access to the medication. She has referred to medication abortion as “chemical abortion,” a term frequently used by anti-abortion activists.
“Abortion is corrosive to children, women and society broadly because it devalues and extinguishes innocent human life,” Dr. Overton and her co-author wrote. “Unfortunately, federal policymakers have recently expanded access to abortion pills, also called chemical abortions, which are far more dangerous to women, enabling rapid access to abortion.”
Vaccines are likely to be another flashpoint.
Dr. Overton, who has a medical degree and a doctorate in clinical investigation, played key roles developing administration policies that many public health experts say have eroded trust in vaccines.
She worked on an effort to upend longstanding advice from the Centers for Disease Control and Prevention, eliminating recommendations for children receive vaccinations for flu, RSV, rotavirus, meningococcal disease, hepatitis A and hepatitis B.
The change has been blocked by a court for now, but Dr. Overton described a presidential executive order issued in August as a way to encourage states to adopt the pared-down recommendations anyway.
If confirmed, Dr. Overton would lead the agency through a number of high-profile decisions and initiatives on other issues across the agency’s vast portfolio, including medications, food, tobacco and medical devices, which include diagnostics and A.I. software.
Lawmakers have been particularly interested in the agency’s recent changes in tobacco policy, which have followed large donations from the industry and included new authorizations of flavored e-cigarettes. The topic was contentious within the administration and led to the resignation of Dr. Marty Makary, the former commissioner.
The agency is also in the process of discussing how it might regulate advanced artificial intelligence tools such agentic A.I., which can perform tasks of physicians like prescribing medications. Given the lack of rules applicable to newer A.I. models, the agency is allowing some A.I. pilots to go forward without agency authorization. One enables an A.I. chatbot to provide therapy to Medicare patients with anxiety or depression.
Early next year, the F.D.A. will also reconvene a panel to determine whether untested and unproven peptide injections should be added to a list of substances that are allowed to be dispensed by specialized pharmacies.
Telehealth companies, including Hims & Hers and Noom, sent representatives to a recent hearing who expressed interest in selling the substances, which are popular among social media influencers. Such sales could expose a wide swath of the public to products with little safety testing. Health Secretary Robert F. Kennedy Jr. has said he would like to see them made widely available.
Food safety has also become a pressing topic. Over the summer, an outbreak of food-borne illnesses from the cyclospora parasite on lettuce sickened thousands. F.D.A. officials are working on reports about their investigation of a Taylor Farms processing center in Mexico tied to the outbreak.
The agency has also moved forward with a proposed rule to close a loophole that allows companies to introduce new chemicals in food with no notice to the agency. The proposal allows companies to avoid detailed reporting requirements during an initial 45-day period after it is finalized and also if they claim that the ingredient is consumed in minimal amounts across a typical diet.
Those exemptions render the rule nearly meaningless, said Scott Faber, senior vice president of government affairs for the Environmental Working Group. He said Dr. Overton, if confirmed, should tear up the proposal and write a stronger one.
“Food safety is a kitchen table issue,” he said, “and consumers are more concerned than in any time in my career that the food they’re eating may make them sick either right away or years from now.”
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