Following a report from Bloomberg suggesting U.S. Food and Drug Administration (FDA) Commissioner Marty Makary is “slow walking” a review of the abortion pill until after the midterm elections, pro-life activists are calling for him to be fired.
The report from the left-leaning outlet, based on information from “people familiar with the matter,” has been disavowed by the White House and Makary, who told the Daily Signal on Tuesday the report is based on “rumors” and said a review of the abortion pill is “ongoing.”
“There’s a lot of rumors that are circulating out there,” Makary told reporter Elizabeth Troutman Mitchell. “We live in a very partisan time, and so you’re going to see the echo chambers of social media sort of magnify rumors, things that are just not true. There has been an ongoing review of mifepristone.”
Mifepristone is the first drug used in a two-drug medication abortion regimen. The drug has become a significant battlefront for the pro-life movement following the fall of Roe v. Wade in 2022 and the Biden administration’s actions allowing abortion pills to be prescribed via tele-health and sent through the mail into red states. Medication abortions are estimated to have accounted for roughly two-thirds of abortions in 2023.
Earlier this year, a shocking study was released suggesting complications from abortion pills are 22 times higher than previously reported by the FDA. The study prompted outrage from the pro-life movement and Republicans, who secured promises from the FDA and Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. that the agencies would comprehensively review the safety around mifepristone.
At the very least, conservatives have pleaded with HHS and FDA to restore earlier safeguards on the drug, including revoking the policy allowing abortion pills to be sent by mail and restoring mandatory in-person doctor’s appointments. Pro-life doctors note that in-person visits allow doctors to check for ectopic pregnancies and gestational age — two factors which can make taking abortion pills more dangerous for women when gone unchecked.
But months have rolled by, the first year of President Donald Trump’s second term is almost over, and conservatives have yet to see any movement on a mifepristone review. Instead, the FDA approved another generic version of the abortion pill in October.
Leading pro-life groups, including Live Action and Susan B. Anthony Pro-Life America, are now calling for Makary to be ousted.
“If Dr Makary will not act as head of the FDA to protect children and mothers he should be fired,” Live Action Founder Lila Rose said in post to X on Tuesday. “Under his watch abortion pills kill preborn children and endanger women and the study he promised is nowhere to be found. End mail order abortion. Ban the abortion pill now!”
Makary told Mitchell the FDA is currently in the “data acquisition phase” and said he refuses to rush the review and will conduct research “the right way.”
”Ultimately, I’m responsible, and so this analysis is going to be done under my auspices, and it’ll be reported up to me,” he said, “and I’m going to be involved.”
“We’re not going to decide what the results are before we’ve done the study,” he later said. “We’re doing the study the right way. And when you do the study the right way, and I’ve done dozens of these studies as a Johns Hopkins professor, you gotta do the studies in data the right way with the right pace.”
He also said the Risk Evaluation & Mitigation Strategies (REMS) policy already mandates the FDA to perform an ongoing review of the drug.
“There’s always an ongoing review of that medication, and we need to be open to the fact that maybe there’s a new drug interaction that was not appreciated,” he said.
As for greenlighting another generic abortion drug, Makary said the agency had to approve it or face a lawsuit.
“There’s a law that requires the FDA to approve a molecule if it’s similar to a branded molecule, so we had no discretion,” Makary told Mitchell. “If we chose to look at that application and say, no, we’re not going to approve this, we’d 100% get sued, and we’d 100% lose.”
“It would all happen very quickly because the law is very clear now with drugs that we approve as new branded drugs,” he added. “It’s a very different law. So we have discretion to weigh risks and benefits. But when it comes to generic compounds, the law is pretty clear.”
Sen. Josh Hawley (R-MO), who has been aggressively pressuring the FDA to take action and to restore previous safeguards around mifepristone, responded to Makary’s interview comments in a letter on Dec. 10, demanding more information about the ongoing review.
“Yesterday, in response to the latest reports, you said, ‘There has been an ongoing review of mifepristone. It’s actually required as part of a policy called REMS.’ But that is not what you promised,” Hawley wrote.” You promised a new and comprehensive study taking account of all available safety data, not the standard monitoring FDA already performs for countless drugs.”
“It is time for director answer about what, precisely, FDA is doing,” he continued.
A spokesperson for the White House on Tuesday told the Hill it has the “utmost confidence” in Makary and said calls for his firing “uninformed attacks.”
“FDA Commissioner Marty Makary is working diligently to ensure that Americans have the best possible, Gold Standard Science study of mifepristone,” White House spokesperson Kush Desai told the outlet.
“The White House maintains the utmost confidence in Commissioner Makary, whose leadership at the FDA has delivered and continues to deliver one landmark victory for the American people after another, from cracking down on artificial ingredients in our food supply to conducting the first safety review of baby formula in decades,” Desai said. “Uninformed attacks against Commissioner Makary from individuals outside the Administration will not change these facts.”
The White House reportedly added that these kinds of comprehensive reviews take a significant amount of time to complete.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton
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