President Trump posted on Truth Social that he is nominating Dr. Heidi Overton to be the next FDA commissioner.
Overton would fill a vacancy left by Dr. Marty Makary, who resigned in May after leading the agency for 13 months.
Overton trained as a surgeon. Her current role is deputy assistant to the president for domestic policy at the White House.
Dr. Joshua Sharfstein, who was the principal deputy commissioner at the FDA during the Obama administration, says that moving from the White House to the FDA could be eye-opening.
"In any administration, there are White House advisers who are walking around saying, 'Why can't FDA just do this? What FDA should really do is that,'" he says. "And then you get to the FDA and you realize there's actually another side of the story."
He says that side includes hearing from career scientists with deep expertise in analyzing the safety of medications, for example.
In Sharfstein's opinion, leading the FDA might be the hardest health job in government. It has a staff of around 18,000 people, and is responsible for regulating food, drugs, and medical devices — as well as tobacco, cosmetics, supplements and other products.
Successful FDA commissioners, in Sharfstein's experience, need a good brain — but also a strong spine. In other words, you have to be smart but also tough. "There's all kinds of pressures — there are political pressures, there are business pressures, there are advocacy pressures coming all the time," he says.
When Overton worked at the conservative America First Policy Institute, she wrote papers opposing gender-affirming care for minors. She also has questioned the safety of medication abortion and suggested the FDA was wrong to allow it to be prescribed via telehealth.
On Aug 10, President Trump issued a controversial executive order pushing to change the childhood vaccine schedule, and dredging up debunked theories linking vaccines to autism. Speaking at the press conference, Overton called Trump's order "a historic action."
She also backed his call for the production of individual vaccines for measles, mumps and rubella. Those vaccines are often given together in a single shot known as MMR, or sometimes MMRV, if the chickenpox vaccine is included.
"We do still recommend the measles vaccine for all children, but we want parents to be informed about the timing and to have the option to separate them out," she said.
Sharfstein and other public health experts have pointed out there's no science to support giving the measles vaccine in a separate shot from the mumps and rubella vaccines.
Unbundling those vaccines and manufacturing new ones could raise costs and increase the chance that children miss doses.
Overton still needs Senate confirmation to become FDA commissioner. Sen. Patty Murray, D-Wash. has already said she will vote no. Sen. Bill Cassidy, a Republican from Louisiana and gastroenterologist, also voiced concerns on social media but didn't say how he would vote.
NPR reached out to the White House to set up an interview with Overton but had not received a response at the time of publication.
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