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# Supreme Court Agrees to Hear Mifepristone Case
- URL: https://www.fdaweb.com/supreme-court-agrees-to-hear-mifepristone-case/
- Published: 2023-12-13T12:00:00.000Z
- Updated: 2026-09-14T14:18:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155992

The U.S. Supreme Court has agreed to hear arguments in an appeal of the 5th Circuit Court of Appeals decision (Danco Laboratories v. Alliance For Hippocratic Medicine, et al.) that sharply restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex). The justices wiil hear one hour of oral arguments at a yet-to-be-scheduled session early next year.

In requesting the Supreme Court’s review, an FDA [filing](https://www.supremecourt.gov/DocketPDF/23/23-235/290359/20231121161708683%5F23-235%20Alliance%20for%20Hippocratic%20Medicine%20reply.pdf?ref=fdaweb.com) last month said the 5th Circuit’s [decision](http://fdaweb.com/login.php?sa=v&aid=D5154207&cate=&stid=%241%24xh..md0.%24NCIbS35BbpJdemxc1DW8e0&ref=fdaweb.com) contradicts fundamental principles of Article III of the Constitution and administrative law and affirms disruptive nationwide relief. It says the drug industry has warned that the decision would “upend” a “settled regulatory scheme” and “stifle pharmaceutical innovation.” And it tells the court that organizations representing hundreds of thousands of medical professionals have said the decision would undermine patient safety and impede the provision of quality healthcare by forcing FDA to return to an obsolete regulatory regime for the drug.

In the brief submitted on behalf of FDA, the Solicitor General said FDA acted lawfully in 2016 when it increased mifepristone’s gestational age limit, reduced the number of required visits, and allowed certain non-physicians to prescribe it, among other changes.

The brief also contended that the Alliance for Hippocratic Medicine and others lack standing to bring the case, the district court’s remedy was improper in its attempt to postpone the effective date of FDA actions that have long been in effect, and the 5th Circuit’s decision warrants review because, as FDA principal deputy commissioner **Janet Woodcock** explained, staying the agency’s actions would “create significant chaos for patients, prescribers, and the healthcare delivery system” by rendering all extant doses of mifepristone misbranded.