The Supreme Court stayed the Fifth Circuit's May 1 order reimposing in-person mifepristone rules, preserving telehealth access nationwide while appeals proceed. Thomas and Alito dissented.
The full Supreme Court on May 14 granted an emergency stay of a Fifth Circuit order that had reinstated a nationwide in-person dispensing requirement for mifepristone, preserving telehealth and mail-order access to the drug while litigation continues [1]. The Court's unsigned order drew dissents from Justices Clarence Thomas and Samuel Alito, with Alito characterizing the stay as "remarkable" and Thomas invoking the Comstock Act as a basis for restricting access [3]. The stay will remain in force through the conclusion of the Fifth Circuit appeal and any subsequent petition for certiorari [3].
The underlying Fifth Circuit ruling, issued May 1, had abruptly reversed FDA's 2023 rule authorizing telehealth prescribing and mail dispensing of mifepristone, a regulatory expansion the agency adopted following post-pandemic clinical reassessments [2]. The cases, Danco Laboratories v. Louisiana and GenBioPro v. Louisiana, consolidate challenges brought by pharmaceutical manufacturers against the state of Louisiana, which had sought to reimpose dispensing restrictions the FDA had lifted [1]. The litigation is proceeding before the U.S. Court of Appeals for the Fifth Circuit, with the Supreme Court's shadow-docket intervention preserving the pre-May 1 status quo [3].
The ruling carries substantial practical reach. Mifepristone is used in more than 60 percent of abortions performed in the United States, and telehealth prescribing has become the primary access channel in states where clinic capacity is limited [1]. The Fifth Circuit's now-stayed order had operated nationwide, meaning its reinstatement of in-person requirements would have applied beyond Louisiana's borders. The Court's decision to intervene before merits briefing is complete signals that a majority found a sufficient likelihood of irreparable harm to justify emergency relief [2]. Alito's dissent, and Thomas's separate invocation of the Comstock Act, flag the doctrinal arguments that challengers are likely to press when the case returns to the high court on the merits [3].
The stay sets a clear procedural runway. The Fifth Circuit will proceed to full merits review of the FDA's dispensing rules, after which the losing party is expected to seek Supreme Court review [1]. Given the circuit court's track record on this litigation and the magnitude of the access question, a certiorari petition and eventual merits argument before the Court appear probable [2]. Both manufacturers and reproductive-rights advocates have indicated they will defend the FDA's 2023 rules as squarely within the agency's statutory authority over drug safety and dispensing conditions.