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Food & Drug Administration v. Alliance for Hippocratic Medicine

No. 23-235 SCOTUS · Decided Decided SCOTUS
Cert Granted: Dec 13, 2023 Argued: Mar 26, 2024 Decided: Jun 13, 2024

Case Overview

A coalition of anti-abortion physicians' groups challenged the FDA's approval of mifepristone and its subsequent actions expanding the drug's availability. The Supreme Court held 9-0 that the plaintiffs lacked Article III standing to challenge the FDA's mifepristone actions because they failed to demonstrate a cognizable injury traceable to the challenged regulatory decisions.

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Jan 14, 2026

The Facts

The Alliance for Hippocratic Medicine and affiliated physicians challenged the FDA's 2000 approval of mifepristone for medication abortion and later regulatory decisions allowing mail distribution and eliminating in-person dispensing requirements; plaintiffs claimed that as physicians they might be called upon to treat complications from mifepristone use, even though none prescribed the drug or had any regulatory relationship to it.

The Application

History

The Alliance's claimed injury (potential future treatment of mifepristone-related complications) fails the Article III traceability requirement because it depends on an unbroken chain of independent decisions wholly outside plaintiffs' control: the FDA's approval decision must lead to patient use, which must result in complications, which must then present at plaintiffs' facilities rather than elsewhere. The speculative and attenuated nature of this causal chain, compounded by the fact that plaintiffs had no regulatory obligation tied to mifepristone and no existing patient relationship to anyone likely to use it, rendered the injury insufficiently concrete and imminent to establish standing, particularly where the claimed harm rested entirely on the possibility of treating emergencies that plaintiffs might never encounter.

The Conclusion

**Physicians and organizations that do not prescribe, manufacture, or distribute a regulated drug, and whose claimed injury depends on speculative third-party decisions, lack standing to challenge FDA approval decisions.** Federal courts have no jurisdiction over such suits, leaving questions about the FDA's regulatory authority over mifepristone for future challenges by parties with a direct legal stake.

CourtSupreme Court of the United States
FiledApr 10, 2023
Judge -
CL StatusTerminated
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No circuit court data for this case.

Cert GrantedDec 13, 2023
StatusTerminated
Filed (CL)Apr 10, 2023
View on CourtListener →

Outcome History (5)

  1. Aug 16, 2023 Circuit
    Affirmed Neutral Final Unreviewed

    5th Circuit affirmed in part, each party to bear own costs.

  2. Dec 13, 2023 SCOTUS
    Cert granted Unresolved Final Unreviewed

    Supreme Court granted petition for writ of certiorari filed by Appellant FDA.

  3. Dec 13, 2023 SCOTUS
    Cert granted Unresolved Final Unreviewed

    Supreme Court granted petition for writ of certiorari filed by Appellant Danco Laboratories, L.L.C.

  4. Dec 13, 2023 SCOTUS
    Cert denied Relief denied Final Unreviewed

    Supreme Court denied petition for writ of certiorari filed by Appellee Alliance for Hippocratic Medicine.

  5. Jul 17, 2024 SCOTUS
    Remanded Unresolved Final Unreviewed

    Supreme Court remanded case to the 5th Circuit.

SCOTUS TMR-43ef30a3 Jul 13, 2026
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