The Supreme Court on Friday issued an order that would keep the status quo of access to mifepristone, the abortion and miscarriage drug, as the FDA’s legal battle over the drug’s approval and regulation continues. The court did not explain its reasoning, but noted that Judges Clarence Thomas and Samuel Alito disagreed.
The decision overturns a New Orleans 5th Circuit Court of Appeals ruling that would have restricted access to the drug as the federal government considers an appeal of the district court’s decision. That decision, handed down on April 7 by Conservative District Judge Matthew Kaczmarik, should have denied access to the drug entirely, as the FDA’s approval of mifepristone in 2000 was illegal, as was the agency’s subsequent actions.
However, a three-judge panel of the appeals court determined that the plaintiff in the case — a group of anti-abortion organizations and individuals led by the Hippocratic Medicine Alliance — had exceeded the statute of limitations in which they could legally challenge the FDA approval in 2000. But the judges ruled 2-1 to allow the rest of Kaczmarik’s ruling, overturning FDA actions in 2016 and 2021 that eased restrictions and access to the drug.
If restrictions were reinstated, this would mean that mifepristone would only be available during seven weeks of pregnancy, not 10; that women would have to visit the doctor three times, and not just once, perhaps with the help of telemedicine; the medicine will not be allowed to be sold by mail; and that doctors again had to report all non-fatal side effects.
In an appeal to the Supreme Court, Danco Laboratories, the maker of mifepristone (brand name Mifeprex), said the appeals court’s decision created “debilitating uncertainty” and “regulatory turmoil.” In his address, he wrote:
To distribute Mifeprex under something other than REMS 2023. [the FDA’s latest regulations], Danco should: review labels, packaging and promotional materials; re-certify suppliers; and amend their contracts with suppliers and distributors and policies (among other things). All are currently based on the 2023 REMS. This is Danco’s current distribution model. However, before Danco can make any changes, it must have a new REMS in place that will require Danco to submit and approve an additional non-disclosure agreement (sNDA) from the FDA. This process usually takes months. It is not clear if Danco can continue to distribute mifeprex while this sNDA is pending with the FDA, even if it is technically misbranded, or if it could expose Danco to civil and criminal penalties. And then Danco may need to go through all those hoops again if the injunction is eventually changed or sent in response to an appeal.
Further complicating matters is a ruling by a district judge in Washington blocking the FDA from changing access to mifepristone in 17 states and the District of Columbia. And on Wednesday, GenBioPro, the maker of a generic mifepristone that was approved by the FDA in 2019, sued the FDA to prevent the agency from complying with any order to remove the generic from the market.
Overall, this case is the first time that an inexperienced district judge has ruled to revoke an FDA approval, based in part on the argument that the FDA was wrong in its expert scientific analysis. If anti-abortion groups ultimately win on appeal, it would set a dangerous precedent, opening the floodgates for litigation to override the FDA’s authority in regulatory actions and approvals and plunge drug development into chaos, according to legal experts, the former federal officials and numerous representatives of the pharmaceutical and biotech industries.
The Court of Appeal moved the case to an accelerated timetable and plans to hear the first oral presentations on May 17.