(The Lion) The Food and Drug Administration review of the chemical abortion pill is dragging on, and pro-life advocates and politicians are fed up, especially after a report the delay may be intentional.
“NEW report saying FDA lied to me and other members of Congress & is not actively reviewing the chemical abortion drug at all,” Sen. Josh Hawley, R-Missouri, said in a post on X, referring to a Bloomberg report the delay is to maximize GOP votes in the 2026 midterms. “FDA needs to stop dithering & reinstate the mifepristone safety guardrails. Nothing less is acceptable.”
Hawley sent FDA Commissioner Marty Makary a letter Wednesday requesting he answer several questions regarding mifepristone, its review and its safety, with a deadline of Dec. 15.
“I cannot emphasize enough the danger of playing politics with women’s health,” Hawley wrote.
HHS spokesperson Andrew Nixon denied the accusation Monday, saying, “FDA’s comprehensive scientific reviews take the time necessary to get the science right.”
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Mifepristone, the chemical abortion pill, accounts for 63% of all abortions, according to the Guttmacher Institute. While the current FDA label claims mifepristone is “safe and effective,” insurance-claim studies reported 11% of women experience serious adverse effects after taking it.
More than 1 in 10 women – a statistic 22 times higher than the FDA’s reported 0.5% – suffer serious infection, hemorrhaging, sepsis or are hospitalized after taking mifepristone, according to the Ethics and Public Policy Center’s (EPPC) April study.
Tweet This: More than 1 in 10 women suffer serious infection, hemorrhaging, sepsis or are hospitalized after taking mifepristone.
Health and Human Services Secretary Robert F. Kennedy promised to conduct a review of the abortion pill in a Senate committee hearing in May. Kennedy reassured senators the review was ongoing in another hearing in September.
The FDA’s review of approved drugs, often from complete response letters, can last anywhere from four to 14 months or more, depending on the drug’s classification and the extent of research necessary, according to Regulatory Focus.
Bloomberg reported Makary has ordered officials “to delay the safety review,” according to anonymous sources “familiar with the matter.”
Makary told The Daily Signal reviews of mifepristone are ongoing – one under standard FDA requirements and an additional “robust study.” He said this study is in the “data acquisition phase.”
“There has been an ongoing review of mifepristone. It’s actually required as part of a policy called REMS, and so 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, maybe there’s a complication that was not recognized previously,” Makary said. “And so, 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.”
The Risk Evaluation & Mitigation Strategies (REMS) that Makary referenced approved the removal of an in-person doctor’s visit as a requirement for obtaining mifepristone under the Biden administration.
EPPC President Ryan T. Anderson and Director of Data Analysis Jamie Bryan Hall – the authors of EPPC’s groundbreaking study on the risks mifepristone poses to women – said the in-person doctor visit both determined the stage of the pregnancy and ensured the woman’s safety from coercion, according to an EPPC statement provided to The Lion.
“The Biden FDA used COVID as an excuse to eliminate this in-person doctor visit, at risk to women’s health and safety,” Anderson and Hall said. “Commissioner Makary could – and should – immediately reinstate that vital protection, even as the FDA conducts its own ‘bigger, more robust’ study.”
More than 70% of Americans believe an in-person doctor visit should be required for the prescription of mifepristone, according to a new poll conducted in August.
The Lion has reported multiple cases of men ordering these pills and forcing or tricking a pregnant woman to take them. Seven in 10 abortions are believed to be “unwanted, coerced or inconsistent with the mother’s values and desires,” according to The Federalist.
“We already have seen women coercively poisoned by boyfriends to kill their unborn babies,” Anderson and Hall said. “This couldn’t happen if the FDA once again required in-person doctor visits as they did during the first Trump administration.”
Makary did not directly answer The Daily Signal when asked if an in-person doctor’s visit should be required and whether it was safe for women to take mifepristone directly shipped to them without physician consultation.
“Look, there was concern about the result by the Ethics and Public Policy Center,” Makary said. “Now, that study was done in claims data, so it didn’t have granularity into the patient characteristics in a way that many researchers would want to have. So that’s one of the reasons why we are doing a bigger, more robust study.”
The EPPC study relied on insurance-claims data, demonstrating the number of hospital visits and diagnoses of women who had taken mifepristone within 45 days. Anderson and Hall said EPPC’s study is the largest study conducted, and they believe the FDA will “find similar results.”
The team that would oversee a review of mifepristone has seen five directors since the beginning of 2025, according to Bloomberg. Makary said he ultimately oversees the study.
“I mean, ultimately, I’m responsible, and so this analysis is going to be done under my auspices, and it’ll be reported up to me, and I’m going to be involved,” Makary said.
He explained the long process a study takes from conducting research to reviewing and “cleaning” the data – ensuring no fields are absent. Data analysis considers many confounding variables and often repeats studies to allow for “multiple reviewers or statisticians,” Makary said.
“We’re going to do the study the right way,” he added. “And I can tell you, being in academics, you might think a study can be done in three or four weeks. But the studies, when done properly, are much more involved, and you can’t really predict an end date.”
After Bloomberg’s initial reporting on the post-midterm delay of the review, pro-life leaders and organizations called on the White House to terminate Makary.
“Enough is enough: FDA Commissioner Makary should be fired immediately,” Susan B. Anthony Pro-Life America President Marjorie Dannenfelser said in a statement, as reported by National Review. “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.”
President of the March for Life Jennie Bradley Lichter blamed big pharma and the Biden administration for hiding mifepristone’s harms, saying a review must be immediate.
“Revisiting the safety profile of a dangerous drug that continues to harm American women – and is a go-to tool of abusive & irresponsible men – after its risks were covered up by Big Pharma and the politicized Biden FDA should not be “put off until after the midterms,” Lichter said in a post on X.
Live Action Founder and President Lila Rose echoed the demands for Makary’s removal, saying women and unborn babies are suffering under his watch.
“If Dr. Makary will not act as head of the FDA to protect children and mothers he should be fired,” Rose said in a post on X. “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!”
“It’s politics over women,” Government Affairs Director for Americans United for Life Brad Kehr said. “Votes over safety.”
Several Republicans are up for re-election next November with narrow margins in Congress, and abortion has proven to be a contentious voter issue.
Editor's note: This article was published by The Lion and is reprinted with permission.
