FDA nominee Heidi Overton could tighten mifepristone access rules

The chief executive of America’s oldest pro-life organization told Fox News Digital that President Donald Trump’s FDA nominee, Dr. Heidi Overton, could bring renewed scrutiny to mifepristone, the abortion drug at the center of an ongoing federal safety review.

John Mize, CEO of Americans United for Life (AUL), said he has had five or six conversations with Overton, who is known for her pro-life views. She currently serves as Trump’s deputy assistant for domestic policy.

“I think she’s going to bring objectivity to the issue of mifepristone in a way that will expose this drug for the damage it causes women,” Mize said in an interview on Friday, adding that his organization is “optimistic” that Overton will be a “pro-life FDA commissioner.”

Overton’s nomination comes just weeks after an 18-year-old woman in North Carolina was accused of using mifepristone and misoprostol to terminate a pregnancy at 31 weeks, well beyond mifepristone’s FDA-approved limit of 10 weeks.

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Mize has led AUL for two-and-a-half years, but the nonprofit has advocated against abortion, euthanasia, assisted suicide and other practices it considers threats to human life since its founding in 1971.

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Mize said he believes Overton is the “right candidate” to lead the FDA, citing her experience in government, clinical medicine and medical research. If confirmed, Overton would take the reins of the agency responsible for regulating abortion medication, including mifepristone.

Mifepristone carries an FDA boxed warning, the agency’s strongest safety warning, for the risk of serious and sometimes fatal infections or bleeding.

Prompted initially by COVID-19 pandemic restrictions, the FDA stopped enforcing the drug’s in-person dispensing requirement in 2021 and later removed it permanently after reviewing the available safety data.

Under current FDA rules, patients do not necessarily have to see a physician in person before receiving a prescription, allowing mifepristone to be prescribed after telehealth visit and mailed by a certified pharmacy. Mize wants those rules tightened.

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“Dr. Overton and I share a very similar perspective that the drug is dangerous, particularly in an unregulated way for women,” Mize told Fox News Digital. “I firmly believe she understands the clinical implications of taking a drug with a black box warning and now shipping it in the mail.”

Overton has publicly criticized mifepristone and other abortion drugs, which accounted for about 65% of clinician-provided abortions in 2023, according to the Guttmacher Institute, up from 53% in 2020 before the Supreme Court overturned Roe v. Wade.

In a February 2023 policy brief for the America First Policy Institute, a MAGA-aligned think tank where she previously served as chief policy officer, Overton denounced federal policymakers for expanding access to abortion pills.

She also accused the Biden administration of using the COVID-19 pandemic to wrongly justify allowing mifepristone and misoprostol, a drug that induces early labor, to be sent to patients through the mail.

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Taken together, the two drugs terminate early pregnancies: mifepristone blocks progesterone, a hormone needed to sustain the pregnancy, while misoprostol causes contractions that expel the fetus.

“Abortion is corrosive to children, women, and society broadly because it devalues and extinguishes innocent human life,” she wrote at the time. “America First policies should focus on immediately halting the effort to normalize abortion-on-demand and on broadly recognizing the evidence of the risk posed to women.”

Mize pointed to a 2025 study by the Ethics and Public Policy Center, a conservative think tank, that analyzed insurance claims from 865,727 mifepristone abortions between 2017 and 2023 and found a serious adverse event rate of nearly 11%. This included conditions such as hemorrhaging, sepsis or infection.

The study received immediate pushback, with the medical community saying it used a flawed methodology. The paper was also not peer-reviewed or published in a medical journal, factors Mize said Overton is aware of.

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“It’s not the whole picture, and Dr. Overton would say that,” Mize said. “But it’s an important indicator as to what’s happening in the real world. So I believe she will do a really good job of evaluating the study.”

Mize said he hopes Overton will impose tighter restrictions on mifepristone after reviewing the evidence, potentially restoring a requirement that women see a doctor in person before receiving a prescription.

He described Overton as “measured” and “methodical” while cautioning that pro-life advocates should not expect her to pursue immediate, sweeping changes at the FDA.

“I don’t get the sense that she’s gonna move quickly on issues,” Mize said.

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Dr. Marty Makary, the previous FDA commissioner, resigned in May after clashing with Trump administration officials and Republican lawmakers. He also drew criticism from pro-life activists, who accused the agency under his leadership of slow-walking its safety review of mifepristone.

If confirmed, Overton would inherit the review, which was formally announced in September 2025 and does not have a scheduled completion date. The FDA has noted these types of studies typically take a year or longer to conduct.

After that review is completed, Mize said the next step for Overton, ideally, would be “a longer term, deep dive evaluation on this medication to determine if it should even be on the market.”

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Mize acknowledged that not all the evidence is in yet but made clear that his preference would be to take mifepristone off the market.

“From my perspective, any medication that denies someone the opportunity to live and kills a human being shouldn’t be something that we’re promoting amongst the FDA,” Mize said. “Ultimately, I would love to see this drug removed from the market for those reasons. Culturally, we might not be there right now.”

Overton’s confirmation hearing has not yet been scheduled but is expected to take place after the Senate returns from its summer recess on Sept. 14.