FDA Commissioner Marty Makary Promises Thorough Review of Abortion Pill Dangers

Food and Drug Administration Commissioner Marty Makary is promising a thorough review of the risks and dangers associated with the abortion pill.

That’s in response to pro-life advocates calling for his resignation after reports surfaced that the FDA was slow-walking the review of mifepristone until after the elections.

As LifeNews reported, pro-life groups are accusing him of stalling a critical safety review of the dangerous abortion drug mifepristone until after the 2026 midterm elections. The FDA has delayed a review of safety data for mifepristone at Makary’s request, Bloomberg News reported. Makary has told agency officials to hold off on the safety review until after the midterm elections, according to the report.

Responding to the news, Susan B. Anthony Pro-Life America, a prominent anti-abortion advocacy group, decried the delay as a dangerous inaction that endangers women and unborn children while undermining state protections against abortion. The group’s president, Marjorie Dannenfelser, issued a sharp rebuke on X.

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“Enough is enough. @DrMakaryFDA should be fired immediately. FDA is doing NOTHING while every day abortion drugs take the lives of children, put women & girls at serious risk, empower abusers, & trample state pro-life laws. Reinstate in-person dispensing NOW & do a real study NOW.”

Now, Makary is speaking out publicly in comments to the Daily Signal.

“We do an ongoing review, but we’re also engaging in a robust study that can serve to validate or not validate other numbers that have been put out there in the literature,” he told The Daily Signal in an exclusive interview.

“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.”

The FDA is currently in the “data acquisition phase” of the abortion pill review.

“Appropriately, many members of Congress have said, ‘Hey, this is a good time to check in and do a robust study.’ So, part of a robust study is data acquisition,” he said. “And so, we’re in that data acquisition phase to get the right data to be able to do this study.”

Makary said he is unable to predict the “results or the timeframe” of the review.

“The shutdown was a little bit of a setback in that, but we’re gonna do it and whenever the results are available,” he said, “we’re gonna make them public.”

Markary also said not to believe everything seen in the liberal media.

“There’s a lot of rumors that are circulating out there,” he said. “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.”

In a statement emailed to LifeNews, Dannenfelser expanded on the tweet.

“Enough is enough: FDA Commissioner Makary should be fired immediately. The FDA is doing nothing while every single day abortion drugs take the lives of children, put women and girls at serious risk, empower abusers and trample state pro-life laws. The FDA needs a new commissioner who will immediately reinstate in-person dispensing as it existed under President Trump’s first term and immediately conduct a comprehensive study. Commissioner Makary is severely undermining President Trump and Vice President Vance’s pro-life credentials and their position that states should have the right to enact and enforce pro-life protections. Makary must go.”

Lila Rose, the head of the pro-life group Live Action has also called for Makary’s firing if the FDA can’t produce the analysis sooner rather than later.

She posted on X: “If Dr Makary will not act as head of the FDA to protect children and mothers he should be fired. 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!”

Mifepristone is the first pill, followed by the drug misoprostol, in a regimen for medication abortion in the first 10 weeks of pregnancy. It won FDA approval in 2000. Since then, millions of babies have been killed in abortions and hundreds of thousands of women have been injured.

Pro-life advocates argue that the abortion pills carry serious risks, including hemorrhage, infection and undiagnosed ectopic pregnancy, as listed by the FDA itself. Women can end up in emergency rooms due to heavy bleeding or incomplete abortions, and in 2016, the FDA weakened reporting requirements, limiting reports to deaths only and excluding injuries, infections or hospitalizations, making it difficult to know the true number of women harmed.

A recent analysis of commercial insurance claims involving 865,727 mifepristone prescriptions from 2017 to 2023. It found 94,605 women — nearly 11% — suffered serious complications within 45 days, including hemorrhage in 3.31% of cases, emergency room visits in 4.73%, and sepsis in 0.10%.

Peer-reviewed research found three quarters of ER visits within 30 days after abortion drug use were coded as severe or critical. Two separate, independent studies also found more than 1 in 10 women experience at least one severe adverse event. Complications can include hemorrhaging, infection, sepsis, and even death.

Other issues encompassed infections, transfusions, hospitalizations and life-threatening events like cardiac problems or anaphylaxis. In nearly 3% of cases, the drug failed, requiring surgical follow-up. Multiple women have died from the abortion pill.

A large national poll found 7 in 10 voters want to roll back Biden’s mail-order abortion drug rule and reinstate safeguards like in-person doctor visits.

The delay comes despite earlier statements from U.S. Health Secretary Robert F. Kennedy Jr. this year that the review of mifepristone is ongoing.