FDA says its mifepristone safety review report is expected by March 2027, drawing pro-life backlash

The Food and Drug Administration (FDA) said Oct. 7 that it expects to complete its safety review of the abortion drug mifepristone by March 2027, drawing criticism from pro-life advocates urging officials to restore safeguards on mail-order abortion drugs before then.

In a court-ordered status report, the agency said it expects to receive the study results by mid-December and complete its evaluation and final report by March 2027. The FDA added that it won’t impose any new restrictions on the pill before then.

Health and Human Services Secretary Robert F. Kennedy Jr. announced in May 2025 that he had directed the FDA to review its mifepristone regulations. 

The timeline drew objections from pro-life groups that have pressed the Trump administration to restore the requirement that mifepristone be dispensed in person. Under the Biden administration, the FDA removed mifepristone’s previous in-person dispensing requirement, allowing doctors and pharmacies to prescribe the drug via telehealth and dispense it by mail.

Students for Life of America President Kristan Hawkins said in an Oct. 7 statement that it “shouldn’t take a judge to pry some answers from the FDA on the dangers of chemical abortion pills, nor should it take this long to get them.” 

“This pill was designed to kill,” she said. “Any review that does not acknowledge how this pill is being used today to empower abusers and enrich the new abortion cartel is completely inadequate.” 

She later added, “Today’s status report is incomplete and insufficient.”

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Susan B. Anthony Pro-Life America President Marjorie Dannenfelser similarly criticized the update as “alarming” and urged the Trump administration to act before the review concludes. 

“The administration must correct course — and, more importantly, it must not wait for the study to conclude before acting,” Dannenfelser said. “Peer-reviewed evidence shows that the Biden administration relied on insufficient evidence and flawed assumptions when it removed the in-person dispensing requirement.” 

Dannenfelser estimated that waiting six months for the review to be completed could result in 90,000 additional abortions in states “whose strong protections for unborn children are being circumvented by the mail-order abortion-drug policy.”

According to the filing, the FDA’s study will compare safety outcomes among roughly 100,000 women who used mifepristone with those of women who underwent surgical abortion. The FDA currently approves the use of mifepristone in combination with misoprostol for abortions through 10 weeks of pregnancy. 

While the FDA has labeled the drug “safe and effective,” pro-life advocates have long questioned its safety and the agency’s decision to ease dispensing requirements. An April 2025 Ethics and Public Policy Center study found that about 11% of women who undergo chemical abortions suffer serious complications, such as hemorrhage, sepsis, and infection. The authors calculated that their reported rate was at least 22 times higher than the rate of serious adverse reactions summarized on the drug’s label, as Zeale News previously reported.

The Oct. 7 update stems from Louisiana’s lawsuit challenging the FDA’s current policy on mifepristone, which the state says undermines its pro-life laws by allowing providers to ship abortion drugs into Louisiana.

In January, the Department of Justice urged the court to delay new restrictions on mifepristone, arguing that immediate intervention could disrupt the FDA’s ongoing review. In May, the Supreme Court declined to restore in-person safeguards while the lawsuit proceeded.

The FDA also faces separate challenges from Missouri, Kansas, and Idaho in Missouri federal court and from Texas and Florida in Texas federal court. The Missouri case remains pending, while a federal judge paused the Texas case Aug. 31 until Dec. 1, or the completion of the FDA’s review, whichever comes first.

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