Washington — In a significant move on Monday, Justice Samuel Alito temporarily paused a ruling from an appellate court that had blocked a Food and Drug Administration (FDA) regulation permitting the abortion pill mifepristone to be prescribed online and mailed to patients.
This temporary reprieve was granted by Alito to Danco Laboratories, the producer of mifepristone, and GenBioPro, the maker of its generic version. The administrative stay will last until 5 p.m. on May 11, allowing the Supreme Court additional time to evaluate the drug companies’ appeals to overturn the appellate court’s decision as ongoing litigation unfolds.
Both Danco and GenBioPro have urged the Supreme Court to review the case and make a definitive ruling on its legal aspects. Alito has set a deadline for Thursday for Louisiana officials to respond to the emergency appeals made by the pharmaceutical companies.
This appeal brings the issue of mifepristone’s availability back before the Supreme Court for the second time. Since the overturning of Roe v. Wade in 2022, anti-abortion rights groups have been attempting to limit access to this widely used abortion medication, arguing that the FDA did not thoroughly assess the drug’s safety and efficacy when it initially approved it in 2000 and subsequently relaxed its usage guidelines over the last ten years.
In a related development in 2024, the Supreme Court unanimously dismissed a legal challenge from anti-abortion rights doctors and medical organizations aimed at restricting mifepristone’s availability, ruling that the plaintiffs lacked the standing to sue the FDA.
This previous case addressed a series of regulatory changes by the FDA since 2016, which had made the abortion pill more accessible. These included permitting mifepristone use later in pregnancy, broadening the range of healthcare providers authorized to prescribe it, and removing the requirement for in-person dispensing, thus allowing the medication to be distributed via mail.
Under the prior rules, patients were required to obtain the drug from healthcare providers in person. But the agency suspended enforcement of the in-person dispensing rule during the COVID-19 pandemic and found that the drug “may be safely used without in-person dispensing.” The FDA formally allowed mifepristone to be prescribed through telehealth appointments and dispensed through the mail in 2023.
Following the Supreme Court’s decision preserving access to mifepristone, the state of Louisiana filed a lawsuit challenging the FDA’s move to let mifepristone be delivered by mail. A federal district court in the state, however, paused the litigation in April, which maintained the eased conditions for use of mifepristone while the FDA reviewed its safety.
Louisiana officials appealed to the U.S. Court of Appeals for the 5th Circuit, which agreed on Friday to temporarily block the 2023 rule allowing healthcare providers to prescribe mifepristone remotely and send the drug through the mail.
The unanimous 5th Circuit panel found that the state had legal standing to sue because its Medicaid program covered emergency-room care for two women who experienced complications after receiving the abortion pill from an out-of-state provider.
The 2023 regulation, the judges said, “injures Louisiana by undermining its laws protecting unborn human life and also by causing it to spend Medicaid funds on emergency care for women harmed by mifepristone.”
“Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions and undermines its policy that ‘every unborn child is [a] human being from the moment of conception and is, therefore, a legal person,’” the 5th Circuit panel found.
Louisiana banned abortion, with narrow exceptions, after Roe’s reversal. The state in 2024 also enacted a law that designates mifepristone and misoprostol — the second drug used in a medication abortion — as controlled substances and criminalizes possession without a prescription.
Danco and GenBioPro came to the Supreme Court for emergency relief on the heels of the 5th Circuit’s decision, which Danco said “injects immediate confusion and upheaval into highly time-sensitive decisions.”
“The Fifth Circuit’s unprecedented order forces patients, providers, and pharmacies into immediate uncertainty, with no transition period and no practical guidance,” the drug company wrote in its request. “Patients who have appointments — as soon as this morning — are in limbo. Providers who have already screened, counseled, and prepared patients for care may have to stop midstream, potentially unable to complete treatment plans that were set in motion days earlier.”
In its own emergency appeal, GenBioPro said the 5th Circuit’s decision has “unleashed regulatory chaos” and threatened to abruptly cut off access to mifepristone for patients nationwide, including in states where abortion is legal.
“Patients and clinicians have, for years, relied on dispensing mifepristone without an in-clinic visit, particularly for women from rural areas and those for whom transportation, childcare, or occupational constraints make it difficult to see providers in person,” the company said. “As a direct result of the Fifth Circuit’s order, patients nationwide may face delay or denial of access to time-sensitive medical care, supply-chain disruptions, and attendant health risks.”
