FDA v. Alliance for Hippocratic Medicine

Background

The Food and Drug Administration, a federal agency, approved mifepristone (Mifeprex) in 2000 with strict limits and later eased those rules in 2016 and 2021 to expand who can prescribe it and reduce in-person visits. Several pro-life medical associations and individual doctors sued, asking courts to force FDA to rescind approval or undo the 2016 and 2021 changes. The district court ordered mifepristone off the market, the Fifth Circuit partially disagreed, and this Court agreed to review the 2016 and 2021 actions.

Reasoning

The Court’s central question was whether the doctors and associations had the legal right to sue — that is, whether they showed a concrete injury caused by FDA’s actions. The Court explained that a plaintiff must show a real, particular harm tied to the defendant’s conduct. It rejected the plaintiffs’ theories: claimed conscience harms were blocked by federal conscience protections, economic harms were too speculative and attenuated, and organizational claims failed because groups cannot “spend their way into” a concrete injury. Justice Kavanaugh wrote for a unanimous Court that the plaintiffs lack the required injury and causation, so their lawsuit cannot proceed.

Real world impact

Because the Court dismissed the challenge for lack of legal standing, FDA’s 2016 and 2021 relaxed requirements remain in effect while political and regulatory processes continue. The decision means these plaintiffs cannot use federal court to force the changes undone. The opinion notes plaintiffs remain free to press their concerns with FDA, Congress, or the public rather than in federal court.

Dissents or concurrances

Justice Thomas joined the judgment but wrote separately questioning broader doctrines that let one party assert others’ rights and urging reconsideration of associational and third-party standing in an appropriate case.