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FDA v. Alliance for Hippocratic Medicine

Updated Sep 5, 2026

In brief

The Court reversed the Fifth Circuit because the plaintiffs lacked standing to challenge the FDA's mifepristone actions.

Where it stands
Decided

Decided 9-0 · June 13, 2024 · Opinion by Justice Kavanaugh

What it’s about
The Court unanimously held that the doctor and association plaintiffs lacked Article III standing to challenge the FDA's mifepristone actions. Because standing was absent, the Court did not reach the merits of the FDA's regulatory decisions.
Who it affects
The FDA's challenged mifepristone regulations remain in place. For example, people affected by mifepristone's approved conditions of use are not subject to changes from this lawsuit.

Summary: written with AI from the case record.

Illustration for FDA v. Alliance for Hippocratic Medicine
Conceptual illustration · AI-generated

What it's about

The case centered on the constitutional limit that federal courts may decide only disputes brought by plaintiffs with a concrete legal injury.

Question presented

1. Do respondents have Article III standing to challenge the Food and Drug Administration’s 2016 and 2021 actions with respect to mifepristone’s approved conditions of use? 2. Were the FDA’s 2016 and 2021 approvals of mifepristone arbitrary and capricious? 3. Did the district court properly grant preliminary relief?

What the Court decided

Holding

Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone. 78 F. 4th 210, reversed and remanded.

Result
Reversed

The vote

  • Joined the judgment
  • Concurred in a separate opinion
  • Wrote an opinion
Majority · 8joined the Court's opinion
  1. Kavanaughwrote the opinion
  2. Roberts
  3. Alito
  4. Sotomayor
  5. Kagan
  6. Gorsuch
  7. Barrett
  8. Jackson
Concurring · 1agreed with the result, wrote separately
  1. Thomaswrote separately
9 justices joined the judgment (1 writing separately).

From the opinions

“Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.”

— Justice Brett M. Kavanaugh(majority)

What's next

The case returns to the lower courts after the reversal and remand. The FDA's challenged 2016 and 2021 mifepristone actions remain in effect.

Documents

3

Docket activity

11
  • New analysis added

    Sep 5, 2026 · Court records

  • AI analysis generated: Impact Analysis

    Sep 5, 2026 · Generated

  • AI analysis generated: Opinion Summary

    Sep 5, 2026 · Generated

  • New analysis added

    Sep 5, 2026 · Court records

  • AI analysis generated: Case Briefing

    Sep 5, 2026 · Generated

Show 6 more
  • AI analysis generated: Decision Record

    Sep 5, 2026 · Generated

  • Status changed from null to decided

    Mar 8, 2026 · Court records

  • Status changed from decided to null

    Mar 8, 2026 · Court records

  • Opinion added: opinion

    Jun 13, 2024 · Court records

  • Brief added: Petition

    Sep 8, 2023 · Court records

  • Brief added: Questions Presented

    Court records

More questions

4
What did the Supreme Court rule in FDA v. Alliance for Hippocratic Medicine?
The Court ruled that the doctor and association plaintiffs lacked Article III standing to challenge the FDA's mifepristone actions.
Who won FDA v. Alliance for Hippocratic Medicine?
The FDA prevailed. The Court reversed the Fifth Circuit and did not decide the merits of the FDA's regulatory decisions.
What does FDA v. Alliance for Hippocratic Medicine mean for people affected by mifepristone regulations?
The FDA's challenged 2016 and 2021 actions remain in effect. This lawsuit does not change mifepristone's approved conditions of use.
What happens next after FDA v. Alliance for Hippocratic Medicine?
The case returns to the lower courts after the reversal and remand. The Court's decision ends this challenge by these plaintiffs.

Sources

Primary materials plus reporting. Best-effort analysis: this explainer relies on a mix of primary materials and trusted secondary sources. Official filings and opinions remain authoritative.

Checked Sep 5, 2026Methodology

Court records and filings

Reporting and analysis