Courtroom Blocks FDA From Permitting Unlawful, Lethal Abortion-By-Mail

The 5th Circuit Court of Appeals temporarily halted a Biden-era policy that allowed dangerous abortion drugs to be mailed to women without so much as an in-person doctor appointment, in a unanimous ruling by a three-judge panel on Friday.

Mifepristone is the primary drug in the regimen that euthanizes a baby in utero and expels it from a mother’s body. After it was first approved by the U.S. Food and Drug Administration in 2000, federal safety guardrails required a doctor to examine a woman in person before prescribing it.

Such regulations helped to protect women with ectopic pregnancies, for whom the drug could be deadly, and women at risk of being given the drug against their will. But in 2023, at the direction of then-President Joe Biden, the FDA removed these longstanding protections, allowing abortion pills to be trafficked through the mail without any in-person safeguards.

In 2025, the state of Louisiana sued the FDA, pointing to problems with data the FDA used to justify such a drastic rollback of safeguards. As the 5th Circuit noted, Louisiana “documented how the new regulation had resulted in numerous illegal abortions in Louisiana and in Louisiana paying thousands in Medicaid bills for women harmed by mifepristone.” Later in the decision, the court added that almost 1,000 illegal abortions occurred in Louisiana every month due to the FDA policy. The state asked for a pause on mail-order abortion drugs until the case was decided.

On Friday, the 5th Circuit granted Louisiana’s request. Judge Kyle Duncan, writing for the unanimous panel, observed the lower district court had agreed Louisiana “had standing, was likely to succeed on the merits, and was suffering irreparable harm” from the lax policy. Nevertheless, the district court refused to pause it. Louisiana appealed the district court’s decision, arguing the harms caused by the policy were severe enough to merit the stay.

The 5th Circuit agreed: “We have now three times found that the agency’s progressive relaxation of mifepristone’s guardrails likely lacked a basis in data and scientific literature,” Duncan wrote. “FDA itself now concedes the regulations were marred by ‘procedural deficits’ and a ‘lack of adequate consideration.’”

The latter admission from the FDA came in a letter from Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary in September 2025. After 22 state attorneys general sent a letter to Kennedy and Makary demanding the Trump appointees undo the Biden administration’s dangerous mail-order mifepristone policy, the health officials admitted to receiving “reports of serious adverse events in patients who took mifepristone” and acknowledged a “lack of adequate consideration underlying the prior” approvals of the drug. Kennedy and Makary promised to conduct a new risk evaluation of mifepristone.

There is substantial evidence of the drug’s dangers. A groundbreaking study by the Ethics and Public Policy Center last year examined data from nearly 900,000 drug-induced abortions and concluded, “10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.” Further, the EPPC researchers found that “the real-world rate of serious adverse effects following mifepristone abortions is at least 22 times as high as the summary figure of ‘less than 0.5 percent’ in clinical trials reported on the drug label.”

Shortly after that study, more than 100 organizations urged the Trump FDA to repeal the Biden-era relaxation of safety protections. A poll conducted in August 2025 found that even many Americans who profess to be pro-abortion have concerns about the safety of mifepristone and want to see the FDA restore protections for women.

Yet the Trump administration has moved slowly to respond to those safety concerns, in the eyes of many pro-life advocates. The FDA appears to be waiting until its internal review of mifepristone, promised last year, is completed before the agency will consider undoing the Biden-era mail-order abortion policy. The FDA has even gone so far as to fight against Louisiana’s landmark lawsuit, asking the district court in January to pause the case pending the FDA’s own review of the drug.

“It’s shameful that the Trump administration’s inaction has forced pro-life states to take their battle to the federal courts,” said SBA Pro-Life America President Marjorie Dannenfelser in response to Friday’s ruling. “The FDA does not need a year or more to complete a comprehensive study before it can take dangerous abortion drugs out of the mail.”

Elle Purnell is the assignment editor at The Federalist. She has appeared on Fox Business and Newsmax, and her work has been featured by RealClearPolitics, the Tampa Bay Times, and the Independent Women’s Forum. She received her B.A. in government with a minor in journalism. Follow her on Twitter @_ellepurnell.