A recent decision by the US Court of Appeals for the Fifth Circuit has placed a significant limitation on the prescription of the abortion drug mifepristone, halting the Biden administration’s regulation that permitted its online prescription and mail delivery. This ruling, which acts as a nationwide block on telemedicine prescriptions for the drug, arises from litigation tied to the Supreme Court’s 2022 Dobbs decision that returned the power to regulate abortion to the states. Further insights into this matter can be found in the detailed coverage by JURIST.
The Fifth Circuit’s unanimous decision focused on the claim by Louisiana that the FDA’s removal of mifepristone’s in-person dispensing requirement was both arbitrary and capricious. This argument hinges on the agency’s own admission of procedural shortcomings and insufficient analysis in its Risk Evaluation and Mitigation Strategy. Of particular concern was the FDA’s elimination of adverse event reporting requirements, which the agency later used to support claims of safety for remote dispensing, despite this lack of data.
Mifepristone, which accounts for over sixty percent of abortions in the US, was initially subject to stringent in-person requirements when it was first approved in 2000. These requirements were relaxed during the COVID-19 pandemic, allowing for remote prescriptions, a policy later solidified in the FDA’s 2023 regulation. However, the appeals court’s decision effectively overturns this policy as the litigation proceeds. Detailed information on the decision process is available from The New York Times.
Louisiana’s legal challenge under the Administrative Procedure Act was filed in 2025. The case was strengthened by state claims of nearly 1,000 illegal abortions monthly that the 2023 regulation facilitated, alongside financial implications attributed to complications from out-of-state mifepristone use. The FDA’s acknowledgment of incomplete safety studies only added weight to these concerns.
This decision forms part of a broader landscape of legal battles over mifepristone. Other federal courts are reviewing similar appeals, potentially leading to divergent rulings. The Fifth Circuit emphasized the necessity of addressing the case despite these risks of conflicting outcomes. An additional perspective on the broader implications can be accessed through Reuters.