Supreme Court Stays Fifth Circuit Order Banning Telehealth Prescribing and Mail Dispensing of Mifepristone

On May 1, 2026, the Fifth Circuit Court of Appeals (the “Fifth Circuit”) issued an order banning the mailing of the abortion pill mifepristone, previously permissible under Food and Drug Administration (“FDA”) regulations allowing mifepristone to be prescribed via telehealth and dispensed through the mail. On May 14, the Supreme Court stayed that order pending further proceedings in the Fifth Circuit, which means that the status quo will remain in effect for the foreseeable future. Under the Fifth Circuit’s ruling, patients across the country would have been required to pick up the medication in person, but now they can continue to receive mifepristone prescriptions by mail following prescriptions through telehealth. These decisions follow countless legislative and court challenges to the access to reproductive healthcare since the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health, including challenges to the distribution of mifepristone in particular, and our Dobbs Task Force has carefully covered these developments.

Danco Laboratories, which manufactures the brand version known as Mifeprex®, and GenBioPro, which manufactures generic mifepristone, went to the Supreme Court for a stay of the Fifth Circuit’s order immediately — the very day after the Fifth Circuit’s ruling. Danco and GenBioPro argued that the Fifth Circuit should have applied the same analysis that the Supreme Court used in evaluating a prior challenge to the distribution of mifepristone, FDA v. Alliance for Hippocratic Med., 602 U.S. 367 (2024), to conclude that Louisiana did not have standing. They also defended FDA’s determination that an in-person dispensing requirement is unnecessary on the merits.

After two temporary administrative stays issued by Justice Alito, the full Court stayed the Fifth Circuit’s ruling. That stay will remain in effect throughout further Fifth Circuit proceedings and through the Supreme Court’s disposition of a future petition for a writ of certiorari if any party to the case seeks one. The Court’s decision granting a stay was accompanied by two dissents — one by Justice Thomas and one by Justice Alito. Justice Thomas wrote to express his view that it is a criminal offense to ship mifepristone for use in abortions under the Comstock Act, and that Danco and GenBioPro should not be entitled to a stay based on what he referred to as “lost profits from their criminal enterprise.” Justice Alito dissented to express his view that allowing mifepristone to be dispensed by mail “is the perpetration of a scheme to undermine [the Supreme Court’s] decision in Dobbs.”

Mifepristone is typically used in combination with a second medication, misoprostol, for medical abortion or to assist in the removal of deceased fetal tissue during a miscarriage. The drug was first approved by FDA in 2000 for use during the first seven weeks of pregnancy. In the decades that followed, FDA expanded the authorized conditions for use. In 2016, for example, FDA granted approval to use mifepristone through the first 10 weeks of pregnancy, reduced the number of in-person clinical visits required for a patient to be prescribed mifepristone, and expanded the universe of healthcare providers permitted to prescribe mifepristone to include nonphysicians, such as nurse practitioners. And in 2023, following several years of experience permitting mifepristone prescriptions without in-person visits during the pandemic, FDA officially removed the in-person dispensing requirement from the “risk evaluation and mitigation strategy,” known as “REMS.” 

Since FDA’s “2023 REMS,” mifepristone has become widely available through telehealth, and recent surveys have found that mifepristone and misoprostol together are used for the majority of abortions in the US, with one in four prescriptions done via telehealth. In addition, various states recently adopted shield laws permitting prescribers to provide services via telehealth that are considered lawful in their state, including prescribing mifepristone and misoprostol to patients located in abortion ban states via telehealth, while the prescriber is located in a shield law state. Shield laws generally protect healthcare providers from out-of-state subpoenas, investigations, extraditions, and arrests for providing such care, but only while the provider is physically located in the state with the applicable shield law. State shield laws are currently being challenged in courts, including California’s, Delaware’s, and New York’s shield laws.

Several years after the Supreme Court rejected a non profit’s effort to take mifepristone off the market in FDA v. Alliance for Hippocratic Medicine, the State of Louisiana sued FDA in the Western District of Louisiana, specifically challenging FDA’s 2023 REMS modifications. Because FDA was actively reviewing the 2023 REMS, the district court stayed the case at FDA’s request and denied a preliminary injunction without prejudice. Louisiana appealed and moved for a stay of the 2023 REMS pending that appeal. The Fifth Circuit sua sponte ordered expedited briefing on the request for a stay and, ultimately, granted a stay pending appeal of the district court’s denial of a preliminary injunction. 

The Fifth Circuit concluded that, unlike the plaintiffs in FDA v. Alliance for Hippocratic Medicine, Louisiana had Article III standing to challenge the REMS. On the merits, the court concluded that Louisiana was likely to succeed in showing a violation of the Administrative Procedure Act in relaxing mifepristone’s in-person dispensing requirement, leaning heavily on the court’s prior decision that was vacated by the Supreme Court in FDA v. Alliance for Hippocratic Medicine. Examining irreparable harm, the court concluded that Louisiana faced a substantial risk of irreparable harm without a stay for the same reasons it established Article III standing to sue, and it further concluded that the balance of the equities favored retroactively staying the 2023 REMS, despite the nationwide effect of that decision. 

With the Supreme Court’s stay in place, the 2023 REMS remain in effect, which means that patients can continue to obtain mifepristone prescriptions without an in-person visit while the Fifth Circuit decides the appeal of the denial of a preliminary injunction and while any party to the case seeks Supreme Court review of that decision. The Department of Justice notably did not file a brief in support of or in opposition to the stay application on behalf of the FDA.

Notably, when FDA v. Alliance for Hippocratic Medicine reached the Court in a similar emergency posture, the Court took precisely the same action that it took this week — it granted a stay and allowed the appeal to play out in the Fifth Circuit. Ultimately, the Court then granted certiorari and reversed the Fifth Circuit’s decision based on the plaintiffs’ lack of Article III standing.

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The Goodwin Healthcare team will continue to monitor activity from the courts relating to this case. For more information on the issues discussed in this alert, please contact the authors or reach out to Goodwin’s Healthcare group or the Appellate and Supreme Court Litigation group, or the Goodwin lawyer with whom you typically consult.

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