Last updated on June 7, 2026
Appeals court pauses FDA mail-order mifepristone rules while Louisiana challenge proceeds
A federal appeals court on Friday blocked a Food and Drug Administration rule that allowed mifepristone to be prescribed online and dispensed through the mail, handing Louisiana a procedural victory in a closely watched fight over federal regulation of medication abortion.
The U.S. Court of Appeals for the 5th Circuit granted Louisiana’s request for a stay of the FDA’s 2023 Risk Evaluation and Mitigation Strategy for mifepristone while the state’s Administrative Procedure Act challenge proceeds. The ruling does not decide the ultimate legality of the FDA’s mifepristone policy. But it could limit remote access to the drug while the litigation continues and signals that the court views Louisiana’s challenge as likely to succeed.
Mifepristone, used in medication abortion, has been regulated through an FDA safety program known as a REMS, or Risk Evaluation and Mitigation Strategy. When the FDA approved the drug in 2000, the agency required three in-person visits with a doctor and reporting of serious adverse events. The agency later loosened those requirements. In 2021, it stopped enforcing an in-person dispensing rule. In 2023, it formalized that change, allowing prescription and dispensing without an in-person visit.
Louisiana sued in 2025, arguing that the FDA did not adequately support the 2023 change with data. The state also claimed the rule interfered with its abortion laws and caused financial harm by requiring Medicaid payments for emergency care provided to women who experienced complications after using mifepristone obtained from out-of-state providers.
The district court agreed that Louisiana had standing, showed a likelihood of success and suffered irreparable harm. But it declined to stay the FDA rule after weighing the interests of the FDA, the drug manufacturers and the public. The district court instead paused the case while the FDA continued a broader review of mifepristone protocols.
The 5th Circuit said that approach gave too much weight to the FDA’s ongoing review and to the financial interests of Danco Laboratories and GenBioPro, the companies that intervened to defend the rule. Judge Stuart Kyle Duncan, writing for the panel, said the FDA did not defend the 2023 REMS on the merits and had acknowledged “procedural deficits” and a “lack of adequate consideration” in earlier mifepristone approvals.
The panel also rejected arguments that Louisiana lacked standing or had failed to exhaust administrative remedies. The court concluded that the state alleged both sovereign injury, through interference with its legal code, and financial injury, through Medicaid expenditures.
The decision arrives after the Supreme Court last year rejected a different challenge to mifepristone rules because the physician plaintiffs lacked standing. Louisiana’s case presents a different posture because a state, not private doctors, brought the claim.
The litigation is likely to remain one of the central legal tests of how far states can go in challenging federal drug regulation after Dobbs returned abortion policy to state governments.
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