Published June 22, 2026
On June 22, EPPC Distinguished Senior Fellow Ed Whelan and EPPC fellows Eric Kniffin and Rachel N. Morrison filed an amicus brief before the Fifth Circuit Court of Appeals supporting Louisiana’s challenge to the FDA’s removal of safety requirements for the abortion pill, mifepristone.
In 2023, the FDA eliminated the requirement that mifepristone be dispensed in-person at a medical facility, allowing telehealth prescriptions and mail delivery. Louisiana argues the FDA’s rollback of this safety requirement was arbitrary and capricious in violation of the Administrative Procedure Act. On May 1, 2026, a unanimous Fifth Circuit panel granted Louisiana’s emergency motion to reinstate the in-person dispensing requirement, finding that the FDA’s actions were likely illegal and that its lax safety standards were enabling nearly 1,000 illegal abortions per month in Louisiana and driving up the state’s Medicaid costs. On May 14, the Supreme Court issued an order staying the Fifth Circuit’s order while the case proceeds. Louisiana is now presenting its same legal arguments to a Fifth Circuit merits panel.
EPPC’s amicus brief draws on EPPC’s ground-breaking May 2025 study, authored by EPPC fellow Jamie Bryan Hall and EPPC President Ryan T. Anderson, which used real-world insurance claims data to demonstrate that mifepristone is far more dangerous for women than the FDA has acknowledged, and that eliminating the in-person dispensing requirement makes those risks even higher. The amicus brief also responds to GenBioPro’s feeble efforts to discredit EPPC’s study.
The second half of EPPC’s brief notes that the opposition’s efforts to defend the FDA’s 2023 decision rely on “a deeply flawed opinion” issued by the Biden DOJ that made “brazenly misleading” arguments about a federal law that prohibits sending abortion drugs by mail.
From the brief:
EPPC scholars conducted the largest-known study of the health effects of mifepristone-induced abortions. Drawing on an all-payer insurance claims database that includes 865,727 mifepristone abortions from 2017 to 2023, EPPC’s study identified a serious adverse event rate of 10.93%, which is at least 22 times as high as the summary figure in clinical trials reported on the drug label. This same database reveals that the serious adverse event rate was significantly higher when the FDA’s in-person dispensing requirement was not in effect. These findings directly support Louisiana’s showing of economic and sovereign irreparable harms and confirm the district court’s conclusion that the FDA failed to adequately consider real-world risks when it loosened the REMS.
EPPC collaborated on the brief with local counsel Michelle Ward Ghetti of Ghetti Law.
This is the third brief EPPC has filed in this case supporting Louisiana. EPPC filed an amicus brief with the district court in February 2026 and with the U.S. Supreme Court in May 2026.
Edward Whelan is Distinguished Senior Fellow of the Ethics and Public Policy Center and holds EPPC’s Antonin Scalia Chair in Constitutional Studies. He served as EPPC’s president from 2004 to 2021. He directs EPPC’s program on The Constitution, the Courts, and the Culture.
