Pharmaceutical company Danco Laboratories has filed an emergency application with the U.S. Supreme Court, seeking a stay of an appeals court ruling that temporarily blocks the abortion drug mifepristone from being dispensed through the mail. The application was submitted on Saturday, according to Reuters.
Background of the Ruling
The appeals court ruling, issued unanimously by a conservative three-judge panel on Friday, significantly curtails access to the drug nationwide, particularly in states that have banned abortion. The temporary decision stems from a lawsuit brought by the Republican-led state of Louisiana, which claims that the U.S. Food and Drug Administration (FDA), in adopting a 2023 rule allowing mifepristone to be dispensed through the mail, ignored the risks of serious adverse events such as sepsis and hemorrhaging. The panel ruled that Louisiana is likely to prevail in its challenge.
Danco's Argument
In its Supreme Court application, Danco argued that the ruling “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.” The company emphasized the urgency of the situation, noting that the decision disrupts longstanding medical practices.
Impact on Access
While the ruling is temporary, it marks the first significant curtailment of access to mifepristone in a series of lawsuits challenging the drug’s initial approval in 2000 and subsequent rules that made it easier to obtain. The 2023 FDA regulation removed the requirement that mifepristone be dispensed in person. According to research from the University of Southern California, in states where abortion is legal and doctors can prescribe via telehealth, fewer than 2% of abortion drug prescriptions are filled in person.
Legal Context
Drug companies GenBioPro and Danco Laboratories have intervened in Louisiana’s lawsuit to defend the FDA regulation. The brand-name version of mifepristone, Mifeprex, is Danco’s only product. The Supreme Court previously took up a challenge to the mail-order rule by medical groups and doctors in 2024 but ruled that they lacked legal standing. Missouri, Kansas, and Idaho have since taken over that case, which remains pending. U.S. District Judge David Joseph paused Louisiana’s lawsuit on April 7, pending a review by President Donald Trump’s administration of mifepristone’s safety, which media reports indicate has been delayed until after the November midterm elections. Judge Joseph denied Louisiana’s request to block the 2023 rule but agreed that it was likely unlawful, signaling he would rule accordingly when the case resumes.
