Washington — Justice Samuel Alito on Monday temporarily halted an appellate court order that blocked a Food and Drug Administration rule allowing the abortion pill mifepristone to be prescribed online and dispensed through the mail.
Alito granted temporary relief to the maker of mifepristone, Danco Laboratories, and the manufacturer of a generic version of the drug, GenBioPro. His administrative stay will remain in place until 5 p.m. on May 11. The move gives the Supreme Court more time to consider the drug companies’ requests to set aside the appellate court’s order while litigation proceeds.
Danco and GenBioPro also asked the high court to take up the case and decide the legal merits. Alito set a Thursday deadline for Louisiana officials to respond to the drugmakers’ emergency appeals.
The appeals put the issue of mifepristone’s availability before the Supreme Court for a second time. Anti-abortion rights groups have sought to restrict access to the widely used abortion pill since the high court overturned Roe v. Wade in 2022, claiming that the FDA failed to adequately consider the drug’s safety and effectiveness when it first approved mifepristone in 2000 and relaxed the rules for its use over the past decade.
In 2024, the high court unanimously rejected a challenge from a group of anti-abortion rights doctors and medical groups that targeted mifepristone’s availability, ruling that the plaintiffs did not have the legal right to sue the FDA.
That case involved a series of steps taken by the drug agency since 2016 that made the abortion pill easier to obtain. Those actions included allowing mifepristone to be taken later into a pregnancy, expanding the healthcare workers who can prescribe it and lifting an in-person dispensing requirement to allow the drug to be sent through the 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.”