As was reported in the April 28, 2023 issue of HLBytes, on April 21, 2023, the United States Supreme Court granted a stay to Danco Laboratories, LLC, (“Danco”) the manufacturers of mifepristone and the FDA, following a request for emergency relief of an injunction from a federal district court in the Northern District of Texas, which would have prohibited the distribution of mifepristone throughout the United States. Pursuant to this stay, the current legal status of mifepristone remains unchanged and as it did before April 7, 2023. Here is a more detailed recap to date:
On April 7, 2023, the United States District Court for the Northern District of Texas had stayed the FDA’s 2000 approval of mifepristone and all subsequent agency actions related to that approval but delayed the applicability of its opinion and order for seven days to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.
The federal government sought relief from the Fifth Circuit Court of Appeals who held that the FDA’s 2000 approval of mifepristone could stand, but that subsequent FDA actions regarding mifepristone were subject to challenge. In sum, the Fifth Circuit changed the availability of mifepristone to how it was pre-2016 pending a hearing on the merits.
After two brief stays, on April 14th and April 19th, the Supreme Court issued its April 21st stay that will remain in place pending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari to the Supreme Court, if a writ is sought. Should certiorari be denied by the Supreme Court, the stay will automatically terminate. If certiorari were to be granted, the stay will terminate upon the judgment of the Supreme Court. The Fifth Circuit has scheduled an expedited hearing for May 17, 2023.