The Fifth Circuit voided FDA's 2021 mail-dispensing rule for mifepristone, banning telehealth prescribing nationwide. The Supreme Court issued an emergency stay May 14.
A three-judge Fifth Circuit panel ruled May 1 that the Food and Drug Administration's 2021 decision to eliminate the in-person dispensing requirement for mifepristone was invalid, reinstating a nationwide ban on mail-order and telehealth prescribing of the drug [1]. The panel, composed entirely of Republican appointees, held that Louisiana had standing to challenge the FDA rule based on the state's Medicaid expenditures on treating mifepristone-related complications [1]. The ruling took immediate effect and applied across all 50 states, including those where medication abortion remains legal under state law [1].
The decision arose from a challenge brought by Louisiana against the FDA in the Fifth Circuit, which has jurisdiction over federal agency actions filed within the circuit [1]. Judge Stuart Kyle Duncan was among the panel members [1]. The plaintiffs argued that the FDA exceeded its statutory authority when it removed the Risk Evaluation and Mitigation Strategy requirement mandating an in-person dispensing visit for mifepristone, a change the agency implemented in 2021 [1]. The Fifth Circuit agreed, finding the agency's justification legally deficient [1].
The ruling's practical scope was sweeping. By invalidating the mail-distribution pathway for mifepristone nationwide, the panel effectively curtailed telehealth abortion access in every jurisdiction, regardless of state-level legal protections for abortion [1]. Mifepristone, used in combination with misoprostol, accounts for the majority of abortions performed in the United States, and the mail-order dispensing pathway has expanded significantly since the Supreme Court's 2022 decision in Dobbs v. Jackson Women's Health Organization eliminated the federal constitutional right to abortion [2].
Drugmakers Danco Laboratories and GenBioPro filed emergency applications at the Supreme Court within days of the ruling, warning that the Fifth Circuit's order would cause immediate confusion and upheaval in the provision of reproductive healthcare [2]. The manufacturers argued that reinstating the in-person requirement would disrupt established clinical protocols and cut off access for patients in states where abortion remains protected [2]. The Supreme Court granted an emergency stay on May 14, temporarily restoring the ability to receive mifepristone by mail while the litigation continues [1].
The Court's intervention pauses the Fifth Circuit's order but resolves nothing on the merits. The case is expected to return to the Fifth Circuit for further proceedings, and a petition for certiorari from whichever party loses at that stage appears likely, setting up a potential Supreme Court ruling on FDA's authority to regulate medication abortion dispensing requirements [1] [2].