Danco Laboratories, LLC v. Alliance for Hippocratic Medicine

In 2000, the Food and Drug Administration (FDA) (defendant) approved a drug called mifepristone, which was used to terminate early pregnancy. The approval included conditions intended to promote patient safety. In 2016 and 2021, the FDA amended the conditions, making them more lenient. Additionally, in 2019, the FDA approved a generic version of mifepristone. A collection of medical groups opposed to chemical abortion (plaintiffs), including Alliance for Hippocratic Medicine, sued the FDA in federal district court challenging the FDA’s approvals, conditions, and modifications concerning mifepristone. Danco Laboratories, LLC (Danco) (defendant), the manufacturer of mifepristone, intervened in the suit as a defendant. The medical groups moved for a preliminary injunction suspending all of the FDA’s actions regarding mifepristone while the suit was pending. Instead, the district court considered the merits of the case and issued a stay of the FDA’s actions, which effectively undid mifepristone’s approval and thus prevented its use. The FDA and Danco appealed to the Fifth Circuit, asking the court to stay the district court’s order, and thus reinstate the FDA’s actions and allow the use of mifepristone while an appeal on the merits was pending in the Fifth Circuit. The Fifth Circuit granted the stay regarding the FDA’s original 2000 approval of mifepristone but denied the stay as to the FDA’s other actions, meaning that the district court’s order continued to effectively undo the FDA’s subsequent modifications of the drug’s conditions and approval of a generic equivalent. Although the Fifth Circuit fast-tracked the appeal on the merits, the FDA and Danco sought emergency relief from the Supreme Court. Just two days after the Fifth Circuit’s decision regarding the stay, the FDA and Danco filed an application with the Supreme Court, via Justice Alito, asking the Supreme Court to stay the district court’s order in its entirety while the appeal on the merits was pending.