## Facts

- The Food and Drug Administration (FDA) approved mifepristone, a prescription drug used in medication abortions, subject to conditions on prescribing and dispensing.
- Over time, the FDA amended its regulatory approach to mifepristone to make access easier, including changes that reduced in-person requirements and expanded how the drug could be obtained.
- A group of pro-life doctors and medical organizations sued the FDA under the Administrative Procedure Act (APA), arguing that the FDA’s actions were unlawful.
- The plaintiff doctors did not prescribe mifepristone and did not use it in their own medical practices.
- The plaintiffs claimed standing based on three asserted injuries:
  - Downstream conscience injury: they might have to participate in emergency procedures following medication abortions in ways that conflicted with their moral or religious beliefs.
  - Downstream economic and professional injury: treating complications could divert time and resources from other patients and could increase malpractice exposure or insurance costs.
  - Organizational injury: the plaintiff organizations argued that the FDA’s actions impaired their ability to carry out their missions, requiring them to spend time and resources responding to the FDA’s regulatory choices.
- The district court concluded that the plaintiffs had standing and ruled against the FDA on the merits.
- The FDA appealed, arguing that the plaintiffs lacked Article III standing because their asserted harms depended on actions by third parties and were too speculative.
- The Supreme Court granted certiorari to decide whether the plaintiffs had standing to sue.

## Issues

1. Whether the plaintiff doctors and medical organizations had Article III standing to challenge the FDA’s actions regarding mifepristone.
2. If standing existed, whether the FDA’s actions violated the APA (not reached if standing was absent).

## Decision

- The Court unanimously held that the plaintiff doctors and organizations lacked Article III standing.
- The Court reasoned that the doctors’ asserted conscience-based harms depended on a chain of possibilities involving third parties, including whether other providers would prescribe mifepristone, whether patients would experience complications, and whether those patients would be treated by these particular doctors.
- The Court concluded that the asserted economic and professional harms were likewise too attenuated from the FDA’s actions, resting on speculative downstream events and not showing a concrete, particularized injury traceable to the FDA.
- The Court rejected the organizations’ standing theory where the alleged harm was largely based on the organizations’ own expenditures and efforts opposing the FDA’s actions, rather than a direct effect on the organizations’ legally protected interests.
- Because the plaintiffs lacked standing, the Court did not reach the APA merits.
- The Court reversed the judgment below and remanded with instructions consistent with dismissal for lack of jurisdiction.

## Legal Principles

- Article III standing requires (1) an injury in fact that is concrete, particularized, and actual or imminent; (2) a causal connection showing the injury is fairly traceable to the challenged conduct; and (3) redressability, meaning it is likely the requested relief will remedy the injury.
- A plaintiff cannot establish standing through a speculative chain of future events dependent on independent decisions of third parties not before the court.
- Disagreement with a government policy, without a concrete and personal injury, is not enough to invoke federal jurisdiction.
- Claims of downstream injury must still satisfy traceability; harms that arise only after actions by third parties generally do not meet that requirement.
- An organization generally cannot create standing merely by spending resources responding to a policy; it must show a non-self-generated, concrete impairment of its activities that qualifies as an injury in fact.

## Conclusion

The Supreme Court held that pro-life doctors and medical organizations lacked Article III standing to challenge the FDA’s actions making mifepristone easier to obtain because the alleged conscience, economic, and organizational harms were not concrete and imminent injuries fairly traceable to the FDA and likely to be redressed by the requested relief; accordingly, the Court reversed and remanded without reaching the APA merits.


Food and Drug Administration v. Alliance for Hippocratic Medicine, 140 S. Ct. 1540 (2024)