Page:Danco Laboratories, LLC v. Alliance for Hippocratic Medicine (U.S. April 21, 2023).pdf/3

Rh regulatory “chaos” would occur due to an alleged conflict between the relief awarded in these cases and the relief provided by a decision of the United States District Court for the Eastern District of Washington. It is not clear that there actually is a conflict because the relief in these cases is a stay, not an injunction, but even if there is a conflict, that should not be given any weight. Our granting of a stay of a lower-court decision is an equitable remedy. It should not be given if the moving party has not acted equitably, and that is the situation here. The Food and Drug Administration (FDA) has engaged in what has become the practice of “leverag[ing]” district court injunctions “as a basis” for implementing a desired policy while evading both necessary agency procedures and judicial review. Arizona v. City and County of San Francisco, 596 U. S. ___, ___ (2022) (, concurring) (slip op., at 2).

The Washington District Court enjoined the FDA from altering its current practice regarding mifepristone—something that the FDA had never hinted it was contemplating. The FDA did not appeal that appealable order, and when seven States that might take such an appeal asked to intervene, the FDA opposed their request. This series of events laid the foundation for the Government’s regulatory “chaos” argument.

Once this argument is put aside, the applicants’ argument on irreparable harm is largely reduced to the claim that Danco could not continue to market mifepristone because the drug would be mislabeled and that distribution could not resume until Danco jumped through a series of regulatory steps that would be largely perfunctory under present circumstances. That would not take place, however, unless the FDA elected to use its enforcement discretion to stop Danco, and the applicants’ papers do not provide any reason to believe the FDA would make that choice. The FDA has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the