FDA v. Alliance for Hippocratic Medicine
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.

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
- Concurring · 1agreed with the result, wrote separately
- Thomaswrote separately
From the opinions
“Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.”
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
Docket activity
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AI analysis generated: Impact Analysis
AI analysis generated: Opinion Summary
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AI analysis generated: Case Briefing
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AI analysis generated: Decision Record
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More questions
- 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.