FDA v. Alliance for Hippocratic Medicine

Background

Four pro‑life medical associations and several individual doctors sued the Food and Drug Administration after FDA relaxed rules for the abortion drug mifepristone in 2016 and 2021. The plaintiffs had earlier petitioned FDA and later sought a court order to rescind FDA’s approvals or undo the 2016 and 2021 changes. A district court agreed and ordered mifepristone off the market. The Fifth Circuit partly reversed but held the plaintiffs likely to win against the 2016 and 2021 actions. The Supreme Court reviewed those regulatory changes.

Reasoning

The Court addressed whether the doctors and associations had a legal right to sue under Article III of the Constitution. The Justices explained that to sue in federal court, a plaintiff must show a concrete injury caused by the defendant and that a favorable court decision would fix it. The plaintiffs do not prescribe or use mifepristone and are not regulated by FDA. The Court found their asserted harms—conscience worries, extra medical work, or advocacy costs—were too speculative or broken by other laws. In particular, federal conscience protections and EMTALA do not show doctors would be forced to perform abortions. The Court therefore concluded the plaintiffs lacked the necessary standing.

Real world impact

Because the Court dismissed the case for lack of standing, the plaintiffs cannot use federal courts to undo FDA’s 2016 and 2021 relaxations. Mifepristone remains available under the agency’s rules while other legal or political avenues may be pursued. The decision also limits who may sue to challenge federal drug regulation and leaves some policy disputes to the political branches.