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# Supreme Court Rejects Mifepristone Lawsuit
- URL: https://www.fdaweb.com/supreme-court-rejects-mifepristone-lawsuit/
- Published: 2024-06-13T12:00:00.000Z
- Updated: 2026-09-14T14:33:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157177

The U.S. Supreme Court 6/13 [unanimously rejected](https://www.supremecourt.gov/opinions/23pdf/23-235%5Fn7ip.pdf?ref=fdaweb.com) a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex) by finding that the plaintiffs, a group of anti-abortion doctors, lacked Article III standing to challenge FDA’s actions regarding the regulation of mifepristone. Plaintiffs had challenged FDA actions in 2016 and 2017 that relaxed restrictions associated with mifepristone’s prescribing.

“Here, the plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” the high court opinion says. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions. The plaintiffs may present their concerns and objections to the president and FDA in the regulatory process, or to Congress and the president in the legislative process. And they may also express their views about abortion and mifepristone to fellow citizens, including in the political and electoral processes.”

In an earlier [brief](https://www.supremecourt.gov/DocketPDF/23/23-235/290359/20231121161708683%5F23-235%20Alliance%20for%20Hippocratic%20Medicine%20reply.pdf?ref=fdaweb.com) related to the case, FDA said the lawsuit 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.