The Fifth Circuit ordered the FDA to reinstate in-person dispensing rules for mifepristone, blocking mail and telehealth access nationally. Drugmakers filed emergency Supreme Court applications.
A three-judge Fifth Circuit panel issued an order on May 1 requiring the Food and Drug Administration to immediately reimpose in-person dispensing requirements for mifepristone, wiping out mail-order and telehealth access to the medication-abortion drug across the country [1]. The order carried no geographic limitation, meaning its effect was instantaneous and national in scope [2]. Danco Laboratories and GenBioPro, the two manufacturers of FDA-approved mifepristone formulations, filed emergency applications to the Supreme Court within days of the ruling [1].
The case, Louisiana v. FDA, arises from a challenge brought by the State of Louisiana contesting the FDA's regulatory actions that expanded access to mifepristone, including rules permitting mail dispensing and telehealth prescribing [2]. The Fifth Circuit panel, all three members appointed by Republican presidents, sided with Louisiana and ordered the FDA restrictions reinstated without waiting for further briefing or argument on the merits [1]. The ruling came from the U.S. Court of Appeals for the Fifth Circuit, sitting in New Orleans [2]. Judge Stuart Kyle Duncan was among the panel members [1].
The substantive significance of the order is difficult to overstate. The FDA's authority to liberalize access to medication-abortion drugs had already survived one Supreme Court challenge, in FDA v. Alliance for Hippocratic Medicine, where the Court vacated an earlier Fifth Circuit ruling on standing grounds without reaching the merits [1]. Louisiana v. FDA now presents a vehicle to relitigate that underlying question, and the Fifth Circuit's ruling, framed as an immediate and nationwide injunction, compresses the timeline for Supreme Court intervention [2]. The ruling represents the most consequential abortion-access decision from a federal appellate court since the Supreme Court's 2022 Dobbs opinion eliminated the federal constitutional right to abortion [1].
The emergency applications filed by Danco and GenBioPro ask the Supreme Court to stay the Fifth Circuit order while the litigation proceeds [1]. If the Court declines to act, the in-person dispensing requirement remains in effect nationally, foreclosing mail and telehealth access in all jurisdictions, including states where abortion remains legal [2]. The FDA has not publicly committed to a litigation posture aligned with the prior administration's defense of the expanded-access rules, adding a layer of uncertainty to the federal government's role before the Court [1].