Plain-English summary
Court unanimously holds plaintiffs lack Article III standing to challenge FDA actions on mifepristone; judgment reversed
In a unanimous decision, the Supreme Court ruled that the plaintiffs did not have Article III standing to bring suit challenging the FDA’s 2016 and 2021 actions regarding mifepristone. The Court reversed the Fifth Circuit and remanded the case to the district court.
Why this matters
This ruling limits who can sue to challenge federal regulatory actions about approved drugs. By rejecting the plaintiffs’ standing, the Court kept in place the FDA’s regulatory decisions on mifepristone for now and underscored the requirement that plaintiffs show a concrete, personal injury traceable to the government action before federal courts will decide regulatory disputes.
Who may feel it
- Patients and clinicians who prescribe or use mifepristone
- Pharmaceutical manufacturers and drug regulators (FDA)
- Advocacy groups that bring lawsuits to challenge or defend regulatory decisions
- Lower courts that handle challenges to federal regulatory actions
Key questions
- Do the plaintiffs have Article III standing to sue over FDA actions that expanded access to mifepristone?
- If plaintiffs do have standing, were the FDA’s 2016 and 2021 actions arbitrary and capricious under the Administrative Procedure Act?