On Saturday, two companies that manufacture mifepristone came to the court in Danco Laboratories v. Louisiana, asking the justices to pause a ruling by the U.S. Court of Appeals for the 5th Circuit in a lawsuit by Louisiana that reinstated the requirement that the drug, which is used in about 60% of abortions nationwide, be dispensed only in person. Danco and GenBioPro told the justices that the 5th Circuit’s order was “unprecedented” and “injects immediate confusion and upheaval into highly time-sensitive medical decisions.”
Nearly two years ago, the Supreme Court ruled that doctors and medical groups opposed to abortion did not have a legal right to sue, known as standing, to challenge the Food and Drug Administration’s expansion of access to mifepristone.
The 2024 case, FDA v. Alliance for Hippocratic Medicine, was filed in federal court in Texas by several individual doctors who are opposed to abortion on religious or moral grounds, as well as medical groups whose members are opposed to abortion. The plaintiffs asked U.S. District Judge Matthew Kacsmaryk to rescind both the FDA’s initial approval of the drug in 2000 and its 2016 and 2021 expansions of access to the drug, arguing that mifepristone is unsafe and that the process that the FDA used to approve the drug was flawed.
The FDA, as well as several leading medical groups, countered that, based on extensive evidence, mifepristone is safe and effective. Kacsmaryk, however, suspended the FDA’s approval of the drug and the agency’s later changes, made in 2016 and 2021, to the conditions on the use of the drug – which included allowing the drug to be used through the 10th week of pregnancy, allowing health-care providers who are not physicians to prescribe the drug, and permitting it to be prescribed without an in-person visit.
The FDA and Danco, which manufactures mifepristone, appealed to the 5th Circuit. The court upheld the part of Kacsmaryk’s ruling that rolled back the agency’s 2016 and 2021 changes that had expanded access to mifepristone.
In April 2023, the Supreme Court temporarily put the 5th Circuit’s ruling on hold, ensuring continued access to the drug. In June 2024, it reversed the lower court’s ruling and sent the case back to the lower courts.
In his opinion for the court, Justice Brett Kavanaugh acknowledged what he characterized as the challengers’ “sincere legal, moral, ideological, and policy objections” to elective abortion “by others” and to FDA’s 2016 and 2021 changes to the conditions on the use of the drug. But the challengers could not contest those changes, he said, because they had not shown that they would be harmed by the FDA’s mifepristone policies; under the Constitution, these kinds of objections are not enough to bring a case in federal court.
In October 2025, Louisiana filed its own lawsuit in federal court to seek the reinstatement of the in-person dispensing requirement. It emphasized that it had standing to sue because it had “incontrovertible evidence that … doctors and others are (as the Biden administration intended) sending streams of mifepristone by mail into Louisiana for the express purpose of causing thousands of abortions in Louisiana every year. That conduct directly violates Louisiana’s abortion laws, which – subject to very narrow exceptions (such as to save the life of the mother) – bar virtually all abortions, and prevents Louisiana from protecting the lives of unborn babies despite the promise of Dobbs” v. Jackson Women’s Health Organization, the Supreme Court’s 2022 decision holding that the Constitution does not confer a right to an abortion. “That conduct has directly generated medical emergencies that harm Louisiana women,” the state wrote, “and emergency room visits that harm the state.”
Rosalie Markezich, an individual plaintiff who joined the state’s lawsuit, said that in 2023 she was coerced into taking abortion drugs “that her boyfriend obtained via the U.S. Postal Service from a doctor in California.” If the in-person dispensing requirement had been in effect, she said, she “would have received the protection of a private in-person medical appointment,” during which she would “have been able to tell a doctor that she did not want an abortion.”
After a federal judge put the case on hold while the FDA conducts its own review of mifepristone’s safety, Louisiana went to the 5th Circuit, asking that court to re-impose the requirement while litigation continues. The court of appeals ruled that Louisiana has a right to sue because, by allowing mifepristone to be prescribed by telehealth and sent by mail, the “FDA ‘opened the door for mifepristone to be remotely prescribed to Louisiana women,’” even though Louisiana generally bars abortion.
In their emergency application, the drug companies tell the justices that, like the doctors and medical groups in 2024, “Louisiana is not required to ‘prescribe or use mifepristone’ or to ‘do anything or to refrain from doing anything’ as a result of FDA’s actions.” The companies argue that the 5th Circuit should have applied the same analysis that the Supreme Court used in holding that the doctors and medical groups did not have standing in 2024. They stress that the Supreme Court “has already held that claims of downstream financial harm by doctors who provide follow-up care for treating complications after a medication abortion is too attenuated” to provide standing to sue. Here, they say, “Louisiana’s theory—that it can base standing on having to pay those doctors if someone who received FDA-approved mifepristone through the mail seeks follow-up care to treat a complication—is a more attenuated version of the” theories that the court specifically rejected two years ago. And Louisiana’s claim that it is injured because of the disconnect between federal law and its own state law is not the kind of injury that courts can review, they said.
The drug companies also ask the court to issue a short-term order, known as an administrative stay, that would put the 5th Circuit’s ruling on hold while the justices consider their request.
The drug companies’ request goes initially to Justice Samuel Alito, who handles emergency requests from the 5th Circuit. Alito is likely to ask Louisiana to respond before acting on the companies’ request.