Danco Laboratories, LLC v. Louisiana
The Supreme Court stepped in to keep the FDA's 2023 mifepristone mail-distribution rules in effect, pausing a Fifth Circuit order that had suspended those rules while Louisiana's lawsuit against the FDA plays out.
The unsigned, unexplained order means that for now, mifepristone can continue to be shipped to patients without an in-person medical visit — despite an appeals court having concluded that suspension was warranted. Two justices dissented, each arguing the drug manufacturers had not shown the legal harm required to justify the Court's intervention.
How it got here: Louisiana sued the FDA in federal district court; the district court denied interim relief; the Fifth Circuit suspended the 2023 REMS changes pending appeal; mifepristone manufacturers then applied to the Supreme Court for a stay of the Fifth Circuit's order.
The Case in Depth
What happened
Louisiana sued the FDA, arguing that the agency's 2023 decision to eliminate a longstanding requirement that patients see a medical provider in person before receiving mifepristone — a drug used to end pregnancies — was arbitrary and unlawful. The Fifth Circuit agreed to suspend the 2023 rule change while the case was on appeal. Danco Laboratories and GenBioPro, two companies that manufacture and distribute mifepristone, then asked the Supreme Court to pause the Fifth Circuit's suspension so that mail distribution of the drug could continue in the meantime.
The question before the Court
Should the Supreme Court pause a federal appeals court's order that had suspended the FDA's 2023 rules allowing mifepristone to be distributed by mail without an in-person doctor visit, while mifepristone manufacturers appeal that suspension?
The Court's answer
Yes — the Court granted the stay, pausing the Fifth Circuit's May 1, 2026 order that had suspended the FDA's 2023 mifepristone distribution rules. The stay keeps those rules — which eliminated the requirement that patients visit a medical provider in person before receiving the drug — in place while the Fifth Circuit appeal continues and while any future petition to the Supreme Court to hear the case is pending.
The stay terminates automatically if the Supreme Court ultimately declines to hear the case, and ends upon the Court's own final ruling if it does. The Court gave no reasons for its decision. Both dissenting justices would have denied the stay on the ground that the manufacturers failed to demonstrate the kind of immediate, serious harm that is required before a court can intervene in this way.
Curious how the Court got there? See the step-by-step legal reasoning →
Why it matters
People seeking medication abortions can continue to order mifepristone online and receive it by mail without an in-person appointment, at least while the legal battle continues. States like Louisiana that have banned abortion cannot yet use the Fifth Circuit's ruling to halt those shipments. Mifepristone manufacturers face no immediate disruption to their distribution operations.
What changes now
The Fifth Circuit's suspension of the 2023 mifepristone rules is on hold while the Fifth Circuit completes its review of Louisiana's lawsuit. If the manufacturers do not seek further Supreme Court review, or if the Court declines to hear the case, the stay ends automatically and the Fifth Circuit's suspension would take effect. If the Supreme Court agrees to hear the case, the stay remains in place until the Court issues its final decision. The underlying question — whether the FDA's 2023 rule change was lawful — remains unresolved.
What this does not decide
The order does not decide whether the FDA's 2023 decision to eliminate mifepristone's in-person dispensing requirement was lawful. It does not address the Comstock Act's applicability to mifepristone distribution. It says nothing about state shield laws or Louisiana's broader anti-abortion enforcement efforts.
Concurrences and dissents
How the Justices voted
Dissent (2). Justice Thomas (author).
Dissent — Justice Thomas
“Applicants are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise.”Justice Thomas arguing that mifepristone manufacturers cannot claim legal harm from an order that restricts what he views as criminal conduct under the Comstock Act.
Justice Thomas would have denied the stay on two grounds. First, the manufacturers did not meet the legal standard for emergency relief. Second, and more significantly, he argued that the federal Comstock Act makes it a crime to ship mifepristone by mail or common carrier for use in abortions, meaning the manufacturers are engaged in a criminal enterprise. A party cannot claim to be irreparably harmed by a court order that makes it harder to commit a crime, and granting a stay would disserve the public interest by facilitating ongoing criminal conduct.
Dissent — Justice Alito
Justice Alito would have denied the stay because the manufacturers failed to show the irreparable harm required to justify Supreme Court intervention. Since the FDA was already declining to enforce the in-person dispensing requirement and had no concrete plans to resume enforcement, the Fifth Circuit's order would not actually harm the manufacturers anytime soon. Even if enforcement resumed, the manufacturers could operate under the pre-2023 rules as they had done for years. He also argued that lost profits from sales in states where abortion is illegal are not a legally cognizable injury that courts can protect. He sharply criticized the majority's order as 'unreasoned.' Read the full dissent →
How the Court got there
The legal reasoning, step by step
- The Court provided no written reasoning for granting the stay. As a matter of standard practice, a party seeking an emergency stay must satisfy a four-part test: show a likelihood of winning the underlying case, demonstrate that it will suffer serious and immediate harm without the stay, establish that the other side won't be severely harmed by the pause, and show the stay would serve the public interest.
- Justice Alito's dissent argued the manufacturers plainly failed the 'irreparable harm' requirement — the serious, immediate injury that cannot be fixed with money later. The FDA was already declining to enforce the in-person dispensing requirement before 2023, and there was no sign it planned to resume enforcement; so the Fifth Circuit's order suspending the 2023 rule change would, in practical terms, leave the manufacturers' operations untouched for the foreseeable future.
- Alito further argued that even if enforcement resumed, the manufacturers could simply operate under the pre-2023 rules — a set of requirements they had complied with successfully for years. He noted they had devoted only three of their eighty-plus pages of briefs to demonstrating irreparable harm, and their showings were insufficient: operational inconveniences do not meet the legal bar.
- Justice Thomas's dissent focused on a different threshold problem: he argued that the Comstock Act — a federal law banning the use of the mail or common carriers to ship drugs intended to cause abortions — made the manufacturers' distribution of mifepristone into states like Louisiana a federal crime. Because a party cannot claim to be irreparably harmed by a court order that makes it harder to commit a crime, Thomas concluded the stay must be denied.
- Despite both dissenters agreeing that the manufacturers had not met their burden, the Court's majority granted the stay without explanation, leaving the 2023 FDA rules intact pending further proceedings.