Danco Laboratories, LLC v. Alliance for Hippocratic Medicine
The Court voted 7 to 2 to pause a Texas federal judge's April 7, 2023 order that would have significantly restricted access to mifepristone, the most commonly used abortion medication, while the case works its way through the Fifth Circuit.
The order is temporary and takes no position on whether the FDA acted lawfully when it approved mifepristone or later expanded access to the drug.
How it got here: A Texas federal judge issued an order on April 7, 2023, restricting mifepristone access; the FDA and Danco separately applied to the Supreme Court to pause that order pending the Fifth Circuit appeal.
The Case in Depth
What happened
A coalition of anti-abortion doctors and medical organizations sued the FDA, arguing the agency acted unlawfully when it approved mifepristone in 2000 and later relaxed restrictions on how the drug could be prescribed and distributed. A federal judge in Texas sided with the challengers on April 7, 2023, issuing an order that would have sharply curtailed mifepristone access. Danco Laboratories, the drug's manufacturer, and the FDA separately asked the Supreme Court to pause that order.
The question before the Court
Should a Texas federal judge's order restricting access to the abortion pill mifepristone be paused while an appeal in the Fifth Circuit plays out?
The Court's answer
Yes — the Court paused the Texas district court's April 7 order while the Fifth Circuit appeal proceeds. The one-paragraph per curiam order provides no explanation for the majority's reasoning. The stay automatically expires if the Supreme Court later declines to take the case; if the Court agrees to hear it, the stay lasts until the Court issues its final decision.
Two justices dissented. Justice Alito argued that the companies and the FDA had not demonstrated the kind of real, immediate, and irreparable harm that is required before a court grants emergency relief. He contended the claimed disruption from conflicting court orders was a problem the FDA helped create through its own litigation strategy, and that Danco's other claimed harm — that it would be unable to market the drug — depended on the FDA choosing to take enforcement action it had given no sign of taking.
Curious how the Court got there? See the step-by-step legal reasoning →
Why it matters
Patients seeking medication abortions can continue to access mifepristone under the rules that existed before the district court's April 7 order. The pause lasts only through the Fifth Circuit appeal and any potential Supreme Court review — meaning access could still be restricted if the challengers ultimately win on the merits.
What changes now
With the stay in place, mifepristone remains available under the rules that existed before the April 7 district court order. The Fifth Circuit appeal was on a fast track, with oral argument scheduled roughly 26 days from the stay order. If the Fifth Circuit rules for the challengers, the case would likely return to the Supreme Court on the merits. This stay is a temporary, emergency measure — it does not resolve whether the FDA's approval or expanded-access rules were lawful.
What this does not decide
The stay does not decide whether the FDA acted lawfully in approving mifepristone in 2000 or in later relaxing restrictions on how it is prescribed and distributed. As Justice Alito noted, the order "would not express any view on the merits" of those underlying questions.
Concurrences and dissents
Dissent — Justice Thomas
Justice Thomas would have denied both stay applications. He offered no written explanation.
Dissent — Justice Alito
“I did not agree with these criticisms at the time, but if they were warranted in the cases in which they were made, they are emphatically true here.”Alito notes the irony of the majority granting a broad emergency stay after other justices had long criticized the Court for such shadow-docket actions.
Justice Alito argued the stay should not have been granted because the applicants failed to show irreparable harm — the central requirement for emergency relief. He contended the claimed regulatory chaos from conflicting court orders was a situation the FDA helped engineer through its own litigation choices, and that Danco's remaining harm theory depended on the FDA electing to take enforcement action it had not indicated it would take. He also noted the irony of the majority granting a sweeping shadow-docket stay after years of criticism from other justices about exactly that practice.
How the Court got there
The legal reasoning, step by step
- The Court applied the standard four-factor test for emergency stays, which asks: how likely is the party seeking the pause to win the underlying appeal, will that party suffer serious and irreparable harm without the pause, will the opposing side suffer serious harm if the pause is granted, and where does the broader public interest lie?
- The majority granted the stay without explaining its reasoning. The brief per curiam order simply announces the stay and sets its duration: it remains in effect through the Fifth Circuit appeal and any subsequent Supreme Court review, and expires automatically if the Court later declines to take the case.
- Justice Alito's dissent challenged whether the applicants had satisfied the irreparable-harm factor. He argued that the claimed 'regulatory chaos' — stemming from an apparent conflict between the Texas order and a separate Washington federal court order — was largely manufactured by the FDA's own choices: the FDA did not appeal the Washington order and opposed efforts by other parties to do so, helping create the very conflict it then cited as a reason for emergency relief.
- Alito further argued that even setting aside the conflict argument, Danco's claim of harm depended on the FDA choosing to enforce against it under the altered rules — something the FDA had previously declined to do in analogous circumstances and had given no indication it would do here.