FDA v. Alliance for Hippocratic Medicine

Supreme Court of the United States · 2024 · Federal Courts

602 U.S. 367 (2024)

Updated August 1, 2026

Federal Courtsassociational standingArticle III standingstandinginjury in factcausationredressabilityunregulated parties

Facts

FDA approved mifepristone in 2000 with restrictions on who could prescribe it, how many in-person visits were required, and what adverse events had to be reported. In 2016 FDA relaxed several conditions, including extending use to 10 weeks, allowing certain non-physician healthcare providers to prescribe it, reducing required in-person visits to one, and limiting adverse-event reporting to fatalities; in 2021 FDA announced it would no longer enforce the initial in-person visit requirement. The plaintiff doctors and medical associations do not prescribe or use mifepristone, but oppose abortion and challenged FDA's relaxed regulation of the drug. They claimed FDA's actions would cause conscience injuries, economic injuries, and injuries to the associations themselves.

Issue

Whether doctors and pro-life medical associations that do not prescribe or use mifepristone have Article III standing to challenge FDA's 2016 and 2021 actions relaxing regulation of mifepristone. More specifically, the question was whether their asserted conscience, economic, and organizational injuries were sufficiently concrete and sufficiently caused by FDA's regulation of others.

Rule

To establish Article III standing, a plaintiff must show (i) an injury in fact that is concrete, particularized, and actual or imminent, (ii) that the injury likely was caused by the defendant's conduct, and (iii) that the injury likely would be redressed by the requested relief. When an unregulated party challenges the government's regulation or lack of regulation of someone else, standing is ordinarily substantially more difficult to establish because causation cannot rest on speculative or overly attenuated links and generally requires a predictable chain of events. An organization also cannot create standing merely by spending money to oppose a defendant's action.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

The National Association of Trauma Nurses and two emergency physicians in Phoenix sue a federal transportation agency after it raises the maximum allowable interstate speed limit for commercial buses. They allege the new rule will lead to more severe crashes, requiring them to spend additional time treating victims in their hospitals.

Do the plaintiffs most likely have Article III standing to seek an injunction against the new rule?

Explanation. No. The majority emphasized that when an unregulated party challenges the government's regulation or lack of regulation of someone else, causation is ordinarily substantially more difficult to establish. Doctors and similar professionals cannot establish standing merely by asserting that looser safety rules may lead more injured people to appear for treatment. That causal chain depends on speculative and attenuated downstream events and would create a limitless form of standing.