The US Supreme Court on Thursday allowed the abortion drug mifepristone to remain available by mail and through telehealth nationwide, staying a Fifth Circuit order that had reinstated an in-person dispensing requirement while Louisiana’s challenge to the drug’s regulation proceeds in the lower courts.
The brief, unsigned order in Danco Laboratories, LLC v. Louisiana and the consolidated case GenBioPro, Inc. v. Louisiana offered no reasoning. The stay will remain in effect through the Fifth Circuit’s disposition of the underlying appeal and any subsequent petition for a writ of certiorari. Should the court deny review, the stay terminates automatically.
Justices Clarence Thomas and Samuel Alito dissented, each writing separately. Alito, who serves as the circuit justice for the Fifth Circuit, had granted earlier administrative stays on May 4 and May 11 that preserved access to mifepristone while the full court considered the manufacturers’ applications.
Alito opened his dissent by calling “the Court’s unreasoned order granting stays in this case…remarkable,” and framed the underlying litigation as concerning “the perpetration of a scheme to undermine” the court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, which returned abortion regulation to the states. He wrote that Louisiana’s enforcement of its near-total abortion ban has been “thwarted” by out-of-state providers, advocacy organizations, and states that have enacted so-called shield laws insulating abortion providers from other states’ civil and criminal processes.
Citing Louisiana’s filings, Alito wrote that “nearly 1,000 abortions” occur in the state each month—more, he said, than before Dobbs. He pointed to New York Governor Kathy Hochul’s refusal to extradite a doctor accused of mailing abortion drugs into Louisiana as an example of the cross-border friction.
On the merits of the stay, Alito argued that Danco and GenBioPro had not made the showing of irreparable injury that Supreme Court precedent requires. He noted the companies devoted only three pages of their 80-page applications to that issue and that the US Food and Drug Administration (FDA) is not currently enforcing the in-person dispensing requirement in any event, having committed to an ongoing internal safety review of the 2023 Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Lost sales in states where the drug’s use would be unlawful, Alito wrote, cannot constitute irreparable harm, citing the principle that “equity demands that profits from unlawful activity be surrendered, not protected.”
Thomas wrote separately and more briefly to argue that the Comstock Act, an 1873 anti-obscenity statute, criminalizes the mailing of mifepristone for use in abortions. “Applicants are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise. They cannot, in any legally relevant sense, be irreparably harmed by a court order that makes it more difficult for them to commit crimes,” Thomas wrote.
The dispute traces to the FDA’s 2023 modification of the mifepristone REMS, which eliminated a longstanding requirement that the drug be dispensed during an in-person medical visit and allowed for telehealth prescribing, mail delivery, and dispensing through retail pharmacies. Louisiana, which prohibits nearly all abortions, sued the FDA in October 2025, arguing that the rule change was arbitrary and capricious under the Administrative Procedure Act and that the mailing of the drug violates the Comstock Act.
A federal district court in April found Louisiana was likely to succeed on the merits but declined to enjoin the 2023 REMS, instead staying the case to allow the FDA to complete a pending safety review. Louisiana appealed, and on May 1 a three-judge panel of the Fifth Circuit granted the state’s request to suspend the 2023 REMS while the appeal proceeds, effectively reinstating the in-person dispensing requirement nationwide. Danco Laboratories, which manufactures the brand-name version of mifepristone, and GenBioPro, the generic manufacturer, filed emergency stay applications the following day, warning of immediate disruption to ongoing medical care. Both companies had intervened as defendants below.
Mifepristone’s safety profile is itself a subject of intense dispute. The FDA, which has reviewed the drug repeatedly since approving it in 2000, estimates the rate of serious adverse events at approximately 0.5 percent and mortality below 0.001 percent, and major medical organizations including the American College of Obstetricians and Gynecologists characterize it as safe and effective in early pregnancy. Anti-abortion groups and several Republican officials contend the FDA’s 2023 loosening of restrictions was not adequately supported by safety data. US Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary launched the agency’s pending internal review after citing a report from anti-abortion think tank the Ethics and Public Policy Center, which estimated an 11 percent rate of serious adverse events among patients using mifepristone. Notably, the EPPC figure was based on research that has been called into question by reproductive health researchers, misinformation experts, and major news outlets.
The case drew considerable amicus participation in the eight days between Danco’s application and Thursday’s order. Twenty-two states led by New York, 259 members of Congress, the American College of Obstetricians and Gynecologists, the Pharmaceutical Research and Manufacturers of America, and a coalition of former FDA commissioners urged the court to grant the stay. A coalition of 23 states led by Nebraska, 113 members of Congress led by Senator Bill Cassidy (R-La.), the Family Research Council, and Susan B. Anthony Pro-Life America were among those urging the court to leave the Fifth Circuit’s order intact.
Following Thursday’s ruling, reproductive rights advocates and medical providers lauded the decision, but warned the battle remained underway.
Planned Parenthood said via social media: “Today, the US Supreme Court blocked the 5th Circuit’s ruling restricting access to mifepristone. While mifepristone access remains unchanged for now, threats to abortion access are far from over. Planned Parenthood will keep fighting to provide access to this care.”
Hey Jane, which describes itself as the country’s “leading virtual abortion clinic,” issued a statement on behalf of CEO Kiki Freedman. “We welcome today’s Supreme Court decision to grant the stay. Courts should not interfere with FDA’s expert decisions allowing mifepristone to be prescribed by telehealth. Patients should not have to navigate legal chaos and confusion to continue accessing safe, legal medication abortion,” she wrote.
Critics warned the ruling exposes women to medical risk and impinges on states’ rights to establish their own abortion policies. Heartbeat International, an anti-abortion advocacy organization, said in a statement: “Women deserve better than dangerous abortion drugs sent through the mail without physician oversight or in-person support. A state, like Louisiana, that values life in its laws should be able to protect its smallest residents as well as their moms. A judicial system that fails to do so will mean we can only be the United States of Abortion. A state, or even a nation, that cannot protect its next generation is doomed to decline.”
