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# High Court Skeptical on Mifepristone Restrictions
- URL: https://www.fdaweb.com/high-court-skeptical-on-mifepristone-restrictions/
- Published: 2024-03-26T12:00:00.000Z
- Updated: 2026-09-14T14:26:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156634

The majority of U.S. Supreme Court justices hinted during oral arguments 3/26 that they were skeptical whether there should be a ban or any new restrictions on the abortion drug mifepristone. Late last year, the high court agreed to hear arguments in an appeal of the 5th Circuit Court of Appeals (*Danco Laboratories v. Alliance For Hippocratic Medicine, et al*.) that sharply restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex).

During oral arguments, a majority of justices appeared likely to dismiss the dispute that challenged the drug’s labeling changes approved by FDA in 2016 and 2021 because the plaintiffs lack legal standing.

An earlier [brief](https://www.supremecourt.gov/DocketPDF/23/23-235/290359/20231121161708683%5F23-235%20Alliance%20for%20Hippocratic%20Medicine%20reply.pdf?ref=fdaweb.com) by FDA said the 5th Circuit’s [decision](http://fdaweb.com/login.php?sa=v&aid=D5154207&cate=&stid=%241%24xh..md0.%24NCIbS35BbpJdemxc1DW8e0&ref=fdaweb.com) contradicted fundamental principles of Article III of the Constitution and administrative law and affirmed disruptive nationwide relief. It said the drug industry had warned that the decision would “upend” a “settled regulatory scheme” and “stifle pharmaceutical innovation.” And it told the high court that organizations representing hundreds of thousands of medical professionals had 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, which was 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 made the points 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 warranted review because, as then 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.