<p>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 has faced criticism for inadequate safety analysis. The Trump administration has not defended the policy on its merits.</p>
<p>The hearing before the 5th U.S. Circuit Court of Appeals in New Orleans comes as Louisiana seeks to stop shipments of the drug, claiming they undermine its near-total abortion ban. The hearing also places pressure on the Trump administration, which has requested that courts wait for a Food and Drug Administration (FDA) safety review before imposing restrictions.</p>
<p>Gabriella McIntyre, legal counsel at Alliance Defending Freedom, which is representing Louisiana in the lawsuit, stated, "Louisiana is being harmed six ways from Sunday because its laws are being circumvented by this mail-order abortion drug scheme." Louisiana, along with 23 other states, is pushing to restore the requirement that mifepristone be dispensed in person, which could end mail delivery nationwide, including in states where abortion is legal. However, even a favorable ruling from the appeals court would not immediately change access, as the Supreme Court has allowed mail delivery to continue during further review.</p>
<h2>Biden-era Changes Under Scrutiny</h2>
<p>The dispute centers on the Biden administration’s removal of the in-person dispensing requirement. The FDA stopped enforcing this requirement during the COVID-19 emergency in April 2021, announced plans to remove it permanently in December, and approved the revised rules in January 2023. The FDA's account of the changes places the initial decision before the Supreme Court overturned Roe v. Wade.</p>
<p>Louisiana argues that the agency failed to adequately justify the change and facilitated abortions that were prohibited under state law after the Dobbs v. Jackson Women’s Health Organization decision.</p>
<p>The 5th Circuit sided with Louisiana in May, ordering a temporary return to in-person dispensing nationwide. The Supreme Court subsequently put that order on hold, allowing mail delivery to continue while the appeal proceeds.</p>
<p>In its May ruling, the appeals court criticized the FDA for relying on a lack of reported complications after the agency reduced prescribers’ obligations to report them. The judges also noted that the FDA's reliance on certain research could not independently establish the safety of dispensing the drug by mail.</p>
<p>The panel described the decision as “a textbook example of arbitrary and capricious agency action.” These findings were preliminary regarding Louisiana’s likelihood of winning, rather than a final judgment on the lawsuit.</p>
<p>The FDA states that mifepristone is safe when used as directed under its prescribing rules. The American College of Obstetricians and Gynecologists and other organizations have 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.</p>
<p>The practical stakes extend beyond Louisiana, as abortions have rapidly increased since the Dobbs decision. The Guttmacher Institute estimated that 91,000 abortions were provided through telehealth to patients in states with total bans in 2025, up from 74,000 in 2024.</p>
<h2>Louisiana Must Demonstrate Harm</h2>
<p>A central question during the hearing is whether Louisiana can demonstrate that the FDA’s policy caused it concrete harm, which is necessary for the state to have the right to sue. This 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.</p>
<p>Louisiana points to interference with enforcement of its laws and taxpayer costs for emergency care following complications. The federal government argues that the connection between these injuries and the FDA’s decision is too indirect to support the lawsuit.</p>
<p>McIntyre indicated that this dispute over causation would likely be a focus of the hearing. Drugmakers Danco Laboratories and GenBioPro have intervened to oppose Louisiana’s challenge.</p>
<p>Alliance Defending Freedom also represents Rosalie Markezich, a Louisiana woman who claims her then-boyfriend coerced her into taking abortion pills. McIntyre stated that restoring in-person dispensing would help protect women from coercion.</p>
<h2>Trump Administration Faces Pressure</h2>
<p>The Trump administration has criticized the Biden-era rules while seeking time for the FDA to reassess them. Attorney General Todd Blanche stated during his July confirmation hearing that the administration would not defend the Biden administration's actions and would allow the FDA’s review process to proceed.</p>
<p>This position has frustrated advocates seeking immediate restrictions. McIntyre argued that a new safety study could not retroactively address flaws in the agency’s original decision, as the lawsuit concerns whether the FDA acted lawfully based on the record at the time.</p>
<p>The timeline for publishing the retrospective analysis could extend beyond the elections, with an administration official stating in June that it was expected to take six months, although initial results could emerge earlier.</p>
<p>A more immediate deadline in federal court is on October 7, when U.S. District Judge David Joseph, a Trump appointee, ordered the FDA to report on its review process and provide an updated completion timeline.</p>
<p>Joseph found that 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.</p>
<h2>Environmental Testing Demanded by Abortion Opponents</h2>
<p>Students for Life, another anti-abortion group aligned with ADF’s efforts, is urging the court to consider whether the FDA adequately examined the environmental impact of mifepristone and its byproducts entering wastewater after at-home abortions.</p>
<p>Kristi Hamrick, vice president of media and policy at Students for Life Action, stated that this issue adds to Louisiana’s concerns regarding the consequences of mail-order abortion drugs. Hamrick estimated that at-home abortions send more than 50 tons of pregnancy tissue, blood, and other waste into wastewater each year.</p>
<p>Hamrick called for water testing and research into effects on wildlife reproduction, advocating for pulling the drug from the market pending testing, which is a broader remedy than Louisiana’s request to restore in-person dispensing.</p>
<p>She also stated that the Trump administration’s safety review should consider environmental effects, although she was uncertain if it would.</p>
<h2>What Happens After the Hearing</h2>
<p>Even after the court issues a decision, abortion pills can be mailed while the legal fight continues. 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.</p>
<p>Oral arguments are scheduled for 9 a.m. Central time Wednesday and will be livestreamed by the court.</p>