Under review

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MARY REICHARD, HOST: Up next on The World and Everything in It, a new leader for the Food and Drug Administration.

President Trump recently said he would nominate White House policy aide Heidi Overton as FDA Commissioner.

NICK EICHER, HOST: The change comes three months after former FDA-chief Dr. Marty Makary handed in his resignation.

That was due in part to pressure from pro-life groups demanding answers about a stalled safety review of the abortion drug mifepristone. Pro-lifers hope Overton will make finishing the review a priority, but her confirmation faces a tight timeline and potential friendly fire in the Senate.

WORLD’s Harrison Watters reports from Washington.

HARRISON WATTERS: A judge in Louisiana says the FDA has five weeks left to provide an update on its safety review of the abortion drug mifepristone.

Back in April, District Judge David Joseph paused a case between Louisiana and the FDA over Biden-era guidelines that allowed mifepristone to be prescribed without the patient seeing a doctor in person. John Mize with Americans United for Life says taking the warning labels off to allow online prescriptions has endangered women.

MIZE: The Ethics and Public Policy Center published an analysis last year that showed, in the real world, using claims data, that about 11% of women that take this medication will have a serious adverse event.

That report sparked a congressional hearing last spring, where Health and Human Services Secretary Robert F. Kennedy Jr. promised he would ask the FDA to investigate.

RFK JR: Clearly, at the least, it indicates the label should be changed.

Mize says the abortion industry has previously provided controlled clinical studies suggesting mifepristone is safe, but:

MIZE: What we haven't seen, other than this claims data from EPDC, is essentially is what the data looks like in the real world, what's actually happening to patients.

That’s where White House policy advisor Heidi Overton comes in. She previously worked at the conservative think tank the America First Policy Institute.

There, she dug into how the Biden administration loosened the rules on mifepristone. letting women get the abortion pill after just a video consultation.

She called that teleabortion, and said Congress should pass laws to protect women and their unborn children.

Mize says Overton could be the kind of public health leader willing to make tough decisions about drugs based on real world impact, not just controlled clinical studies.

MIZE: Having worked in the White House, she understands the the politics behind all of this as well. And when I’ve talked to Dr. Overton, it’s very clear that her goal is peer review, gold standard science, and an objective review.

But her confirmation in the Senate is not a sure thing.

Some lawmakers have concerns about one of her other polices, changing the childhood vaccine schedule. Here’s Overton in a White House press conference in August.

OVERTON: 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…

President Trump ordered HHS to reduce the number of recommended vaccines and split up bundled doses, but Louisiana Senator and physician Bill Cassidy told ABC the move doesn’t make sense.

CASSIDY: Now instead of your child getting two shots, she has to get six shots.

Cassidy took to social media after Trump nominated Overton, saying her vaccine policy work is “ALMOST disqualifying.” He’s also concerned about her lack of management experience…especially for an agency with what he called “staffing and morale issues.”

That matters because Cassidy has the power to block her. He chairs the committee that must advance her nomination. And just one Republican “no” vote on the tightly divided panel would likely stall Overton’s confirmation.

But others argue that her lack of management experience is not necessarily a deal breaker. Scott Gottlieb led the FDA during Trump’s first administration, and he told Face the Nation that Overton could be a strong candidate.

GOTTLIEB: This is first and foremost a policy role. It's really not an operational role.

Dr. Gottlieb says Overton likely knows she’ll need to hire and retain people in key roles. But he’d like to see her clarify her stance on vaccines.

GOTTLIEB: I think hopefully when she has time to explain herself before Congress and get into this in a more substantive way and not just a press conference in the White House, you're going to hear something more thoughtful from her.

The earliest Overton’s confirmation hearing could happen is after the Senate returns in two weeks. Meanwhile, the FDA faces an October 7th court deadline to give an update on its mifepristone safety review.

Reporting for WORLD, I’m Harrison Watters in Washington.

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