Two drugmakers have asked the U.S. Supreme Court to reinstate mail-order access to mifepristone, a step that would preserve access to one of the most commonly used abortion methods while legal challenges continue.
Danco Laboratories and GenBioPro filed their applications on Saturday, a day after an appeals court temporarily halted deliveries, sharply limiting nationwide availability of the drug—especially in states where abortion is banned.
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The lower court’s ruling, although temporary, marks the first major restriction on access to mifepristone in a series of legal challenges targeting the drug’s original 2000 approval and later policy changes that made it easier to obtain.
It also underscores a new phase in the ongoing battle over abortion access following the U.S. Supreme Court’s 2022 decision to overturn Roe v. Wade, which had previously recognized a constitutional right to abortion.
Since that ruling, nearly half of U.S. states have banned or heavily restricted abortion, leading to a rise in medication-based procedures and triggering a wave of legal disputes over access to abortion pills.
Friday’s pause “injects immediate confusion and upheaval into highly time-sensitive medical decisions—and it forces Danco, FDA, certified Mifeprex providers, patients, and pharmacies all to guess at what is allowed and what is not,” Danco said, citing its brand-name version of the drug.
GenBioPro separately said it “firmly believes all people have a right to access safe, affordable, evidence-based health care.”
Mifepristone, used in roughly two-thirds of abortions in the United States, is typically administered alongside misoprostol as part of a two-drug regimen to end a pregnancy within the first 10 weeks.
In 2023, the U.S. Food and Drug Administration, under former President Joe Biden, removed a requirement that the drug be dispensed in person, stating that it is safe and effective.
However, on Friday, a conservative three-judge panel of the U.S. Court of Appeals for the Fifth Circuit, based in New Orleans, unanimously ruled that the Republican-led state of Louisiana is likely to succeed in its legal challenge against that regulation.
Louisiana filed a lawsuit against the U.S. Food and Drug Administration, arguing that the agency overlooked potential risks associated with mifepristone, including serious complications such as sepsis and hemorrhaging.
Limiting access to the drug—particularly through telehealth prescriptions from out-of-state providers—has been a key objective for Louisiana and other Republican-led states that have enacted abortion bans.
The administration of Donald Trump has said it is reviewing the safety of mifepristone, although media reports indicate that the evaluation may be delayed until after the November midterm elections. At the same time, Republican lawmakers have launched their own inquiries into the medication.
Earlier in April, a U.S. district judge temporarily paused Louisiana’s lawsuit while awaiting the outcome of the administration’s review.
GenBioPro in its statement said it remains “concerned that anti-abortion special interests are attempting to undermine the US Food and Drug Administration’s regulatory authority.”
“Our nation is once again facing a generational-defining moment for women’s healthcare,” legal organization Democracy Forward President and CEO Skye Perryman said in a statement.
“The assault on women’s health in America did not stop when we lost Dobbs,” wrote Perryman, who helped push for mail access for the drug previously as the top lawyer for the American College of Obstetricians and Gynecologists.
GenBioPro and Danco Laboratories both intervened in Louisiana’s lawsuit to defend the U.S. Food and Drug Administration’s regulations governing access to mifepristone.
Danco Laboratories markets Mifeprex as its only product, while GenBioPro earns most of its revenue from a generic version of the drug. Another company, Evita Solutions, also manufactures a generic version of mifepristone.
In a separate development, the U.S. Supreme Court agreed in 2024 to hear a challenge to the mail-order distribution rule brought by medical organizations and physicians, but ultimately ruled that they did not have legal standing to file the case. The states of Missouri, Kansas, and Idaho have since taken over the case, which remains ongoing.
