A federal appeals court will consider on Wednesday whether to restore restrictions on mailing the abortion-inducing drug mifepristone, testing a Biden-era policy that judges have faulted for inadequate safety analysis and the Trump administration has declined to defend on its merits.
The hearing before the 5th U.S. Circuit Court of Appeals in New Orleans comes as Louisiana seeks to stop shipments of the drug that it says undermine its near-total abortion ban. The hearing also puts renewed pressure on President Donald Trump‘s administration, which has asked courts to wait for a Food and Drug Administration safety review rather than impose restrictions before the midterm elections.
“Louisiana is being harmed six ways from Sunday because its laws are being circumvented by this mail-order abortion drug scheme,” Gabriella McIntyre, legal counsel at Alliance Defending Freedom, which is helping represent Louisiana in the lawsuit, told the Washington Examiner on Tuesday.
Louisiana, along with 23 other states supporting the effort, is pushing to restore the requirement that mifepristone be dispensed in person while its lawsuit proceeds. That could end mail delivery nationwide, including in states where abortion is legal. But even a favorable appeals court ruling would not necessarily change access immediately, because the Supreme Court has allowed mail delivery to continue during further review.
Biden-era changes face scrutiny
The dispute centers on the Biden administration’s removal of the in-person dispensing requirement. The FDA stopped enforcing it during the COVID-19 emergency in April 2021, announced plans to remove it permanently that December, and approved the revised rules in January 2023. The changes also allowed certified pharmacies to dispense the drug. The FDA’s account of the changes places the initial decision before the Supreme Court overturned Roe v. Wade.
Louisiana argues the agency failed to justify that change adequately and facilitated abortions that were prohibited under state law after Dobbs v. Jackson Women’s Health Organization.
The 5th Circuit sided with Louisiana in May, ordering a temporary return to in-person dispensing nationwide. The Supreme Court then put that order on hold, allowing mail delivery to continue while the appeal proceeds.
In its May ruling, the appeals court faulted the FDA for relying on a lack of reported complications after the agency had reduced prescribers’ obligations to report them. The judges also criticized its reliance on research the FDA acknowledged could not, on its own, establish the safety of dispensing the drug by mail.
The panel called the decision “a textbook example of arbitrary and capricious agency action.”
Those were preliminary findings about Louisiana’s likelihood of winning, rather than a final judgment resolving the lawsuit.
The FDA’s public guidance says mifepristone is safe when used as directed under its prescribing rules. The American College of Obstetricians and Gynecologists and other organizations have also urged the appeals court to preserve access, arguing that research supports remote prescribing and that an in-person requirement would burden patients. The drug is also used in miscarriage treatment.
The practical stakes extend beyond Louisiana as abortions since the Dobbs decision have rapidly accelerated. The Guttmacher Institute, which supports abortion access, estimated that 91,000 abortions were provided through telehealth to patients in states with total bans in 2025, up from 74,000 in 2024.
Louisiana must show the FDA caused harm
A central question during the hearing on Wednesday is whether Louisiana can show the FDA’s policy caused it concrete harm, giving the state the right to sue. That requirement, known as standing, defeated an earlier challenge brought by anti-abortion doctors and organizations at the Supreme Court in 2024. The justices did not decide whether the FDA’s changes were lawful.
Louisiana points to interference with enforcement of its laws and taxpayer costs for emergency care following complications. The federal government’s brief argues the connection between those injuries and the FDA’s decision is too indirect to support the lawsuit.
McIntyre said she expected that dispute over who caused Louisiana’s injuries to be a focus of the hearing. Drugmakers Danco Laboratories and GenBioPro have intervened to oppose the state’s challenge.
Alliance Defending Freedom also represents Rosalie Markezich, a Louisiana woman who says her then-boyfriend coerced her into taking abortion pills. McIntyre said restoring in-person dispensing would help protect women from coercion.
Trump administration faces pressure to act
The Trump administration has taken a different route, criticizing the Biden-era rules while seeking time for the FDA to reassess them.
“We are not defending what Biden did and will not,” Attorney General Todd Blanche said during his July confirmation hearing. He said the administration was allowing the FDA’s review process to proceed.
That position has frustrated advocates seeking immediate restrictions.
“When it comes to what the DOJ could do now, of course they could settle this case tomorrow,” McIntyre said.
She argued that a new safety study could not retroactively fix flaws in the agency’s original decision because the lawsuit concerns whether the FDA acted lawfully based on the record before it at the time.
The timeline for publishing the retrospective analysis could extend beyond the elections. An administration official said in June that it was expected to take six months, although initial results could emerge earlier.
A more immediate deadline in federal court is on Oct. 7, the day U.S. District Judge David Joseph, a Trump appointee, ordered the FDA to report on its review process and provide an updated completion timeline.
Joseph found Louisiana is likely to succeed but paused the case to allow the FDA’s review, prompting the state’s appeal. In granting temporary relief in May, the 5th Circuit concluded that the agency’s review did not justify leaving the challenged rules in place. The panel said a pause in the rules “would do nothing to prevent FDA from completing its review.”
Abortion opponents demand environmental testing
Students for Life, another prominent anti-abortion group aligned with ADF’s efforts, is pressing the court on a separate angle to consider whether the FDA adequately examined what happens when mifepristone and its byproducts enter wastewater after at-home abortions.
Kristi Hamrick, vice president of media and policy at Students for Life Action, told the Washington Examiner that the issue adds to Louisiana’s concerns about the consequences of mail-order abortion drugs.
“What we are saying is that those harms include environmental harms,” Hamrick said.
Its sister organization, Students for Life of America, argued in a June supporting brief that the FDA examined packaging and production waste without adequately considering the drug’s excretion into wastewater. It says the agency failed to consult federal wildlife agencies about risks to protected species under the Endangered Species Act.
Hamrick estimated that at-home abortions send more than 50 tons of pregnancy tissue, blood, and other waste into wastewater each year, a calculation she said was based on annual abortion totals and the estimated weight of expelled tissue. “They can expect more than 50 tons of pathological medical waste to go every year into our waterways,” Hamrick said.
Hamrick called for water testing and research into effects on wildlife reproduction. She advocated pulling the drug from the market pending testing, a broader remedy than Louisiana’s request to restore in-person dispensing.
She also said the Trump administration’s safety review should examine environmental effects, although she did not know whether it would.
“If the study does not cover new grounds, it’s a bad study,” Hamrick said. “And I have to be 100% clear on that.”
What happens after the hearing
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Even after the court issues a later decision, abortion pills can be mailed while the legal fight continues. Even if Louisiana wins at the appeals court, the Supreme Court has allowed time for the losing side to ask the justices to intervene before restrictions take effect. If the justices agree to hear the case, mail delivery can continue until they rule.
Oral arguments are scheduled for 9 a.m. Central time Wednesday and will be livestreamed by the court.