A federal appeals court on Friday halted a Biden-era scheme that allowed the abortion pill mifepristone to be sent via mail.
A three-judge panel for the U.S. Court of Appeal for the Fifth Circuit issued a scathing rebuke of the U.S. Food and Drug Administration’s (FDA) 2023 REMS action permanently removing the in-person dispensing requirement for mifepristone and allowing the drug to be sent via mail. The panel wrote that the Biden administration’s removal of the in-person requirement was an explicit attempt to undermine pro-life state laws in the wake of the Supreme Court’s Dobbs decision and pointed out that the FDA itself has now admitted the move is not backed by rigorous science.
The court also found that Louisiana, which filed the lawsuit against the FDA over the mail-order scheme, has standing to sue, is facing irreparable harm both legally and financially, and will likely succeed in its challenge on the merits. The opinion was written by Trump-appointed Circuit Judge Kyle Duncan and joined by Circuit Judges Leslie Southwick and Kurt Engelhardt, who are appointees of Presidents George W. Bush and Donald Trump.
RELATED VIDEO — “It Is Barbaric and Evil”: Brandon Gill Makes Abortion Advocate Squirm with Graphic Details:
“As discussed, the 2023 REMS injures Louisiana by undermining its laws protecting unborn human life and also by causing it to spend Medicaid funds on emergency care for women harmed by mifepristone. Both injuries are irreparable,” Duncan wrote.
“Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that ‘every unborn child is human being from the moment of conception and is, therefore, a legal person.’ Once lost, that sovereign prerogative of protecting unborn life cannot be regained by legal remedy. And because FDA ‘is entitled to sovereign immunity,’ Louisiana’s financial harms are also irremediable,” he continued.
The FDA first approved mifepristone in 2000 by classifying pregnancy as an “illness.” At the time, guardrails for the drugs — called Risk Evaluation and Mitigation Strategies (REMS) — required only doctors to prescribe the drug after three in-person visits and directed they report serious adverse events. Since then, safety regulations slowly chipped away, including in 2016, when the agency said health care workers only need to report fatalities. The Biden administration temporarily suspended the in-person requirement in 2021 and made the change permanent in 2023.
The State of Louisiana, along with Rosalie Markezich — a woman who alleges her boyfriend was able to order abortion drugs online from California and coerce her into taking the pills — filed a lawsuit against the FDA in October 2025. The lawsuit argues that the FDA acted unlawfully by loosening safeguards around mifepristone and allowing it to be sent via mail, including violating the Administrative Procedure Act (APA).
“By ending the in-person dispensing requirement, FDA opened the door for mifepristone to be remotely prescribed to Louisiana women. The record shows that the policy now facilitates nearly 1,000 illegal abortions in Louisiana per month,” Duncan wrote.
“This evidence also easily shows causation and redressability. As the district court explained, ‘out-of-state medical providers’ have responded to the 2023 REMS by ‘expanding mifepristone access to pro-life states like Louisiana in ways that [are] entirely predictable.’ That should surprise no one: after all, ensuring out-of-state medical providers could prescribe mifepristone to women in states that restrict abortion was a goal of the regulation,” the opinion continues. “Finally, a decision in Louisiana’s favor would redress this injury because mifepristone could no longer be remotely prescribed to Louisianans.”
Duncan also wrote that “in relaxing mifepristone’s in-person dispensing requirement, FDA gave dispositive weight to the lack of adverse-event data in a reporting system (known as “FAERS”).
“The problem? FDA had previously eliminated the requirement to report mifepristone’s adverse events to FAERS. Obviously, it’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision,” Duncan wrote.
“Second, FDA relied on various literature relating to remote prescription of mifepristone—despite FDA’s admission that the literature did not affirmatively support its position,” he continued. The agency explained the literature was not adequate on its own to establish the safety of the model of dispensing mifepristone by mail. This is a textbook example of arbitrary and capricious agency action.”
“Accordingly, like the district court, we conclude Louisiana has strongly shown a likelihood of winning its APA challenge to the 2023 REMS,” he added.
The FDA under the Trump administration has not confronted the merits of the case but has instead asked the courts to allow the mail-order abortion scheme to continue while the agency conducts a safety review of mifepristone. Drug manufacturers Danco Laboratories and GenBioPro have intervened as defendants in the case and have argued pausing mail-order abortions would cause them financial harm.
In April, a district court declined to block the mail-order abortion regulation but put the FDA on notice as the agency conducts its safety review and wrote that Louisiana is “likely to succeed” in its challenge. The federal appeals court disagreed with the lower court’s assessment and decided to block the regulation as litigation continues.
Duncan wrote for the panel, in opposition to the district court ruling, that neither the FDA’s ongoing safety review, nor the drug manufacturers’ financial interests outweigh the injuries to Louisiana and other pro-life states.
“Neither the FDA nor the public has any interest in enforcing a regulation that violates federal law. 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. FDA itself now concedes the regulations were marred by ‘procedural deficits’ and a ‘lack of adequate consideration.’ The public interest is not served by perpetuating a medical practice whose safety the agency admits was inadequately studied. Indeed, the public interest demands the opposite,” he wrote.
RELATED VIDEO — Pro-Lifer: Give Your Baby Life and See What He Does with It:
“For its part, Danco points to a stay’s effect on its compliance costs and mifepristone profits. While we acknowledge a stay would impose costs on Danco, the company exaggerates by predicting a stay would destroy any ‘valid legal framework for distributing’ the drug. To the contrary, a stay would only pause a method of prescribing mifepristone that began five years ago and was formally approved only three years ago,” he continued.
After the Fifth Circuit ruling, the drug companies filed emergency motions with the Supreme Court asking the high court to block the appeals ruling. Pro-abortion groups have bemoaned the decision and warned of a national abortion ban.
Louisiana Attorney General Liz Murrill celebrated the appeals court ruling, saying that the “nightmare is over,” and pro-life groups praised the decision as a step in the right direction.
“The Biden abortion cartel facilitated the deaths of thousands of Louisiana babies (and millions in other states) through illegal mail-order abortion pills. Today, that nightmare is over, thanks to the hard work of my office and our friends at ADFLegal. I look forward to continuing to defend women and babies as this case continues,” Murrill said.
In 2023, the Guttmacher Institute estimated that medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system. That percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. That report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
The pro-abortion organization estimated that in 2025, 91,000 telehealth abortions were provided under blue-state shield laws to people in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
