On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills taken in a medication abortion. However, pursuant to an April ruling by the Supreme Court, no lower-court orders in this case (Alliance for Hippocratic Medicine v. FDA) will take effect until the Supreme Court itself has had the opportunity to weigh in.
The plaintiffs challenged numerous actions by the Food and Drug Administration (FDA) relating to mifepristone, including the original 2000 approval of the drug, subsequent changes to parameters on permissible prescribing and dispensing—referred to as a Risk Evaluation and Mitigation Strategy (REMS)—in 2016 and 2021, and the approval of the generic version of mifepristone in 2019. The district court ruled for the plaintiffs on all counts. In a split 2-1 decision, the Fifth Circuit majority disagreed in part, concluding that the plaintiffs’ challenge to FDA’s original 2000 approval of mifepristone was not timely raised, and further finding procedural defects in plaintiffs’ challenge to the 2019 approval of generic mifepristone.
However, the Fifth Circuit affirmed the district court’s threshold conclusion that the plaintiff physicians and medical associations have standing to challenge these FDA actions in court, as well as the district court’s substantive conclusion that FDA failed to sufficiently support its decisions in 2016 and 2021 to lift various restrictions on mifepristone prescribing and dispensing. Those aspects of the district court’s reasoning were criticized in numerous amicus briefs filed by life sciences companies and patient advocacy groups who fear that, by enabling these types of challenges to FDA’s approvals, this case may jeopardize patients’ access to existing medications and undermine the industry’s incentive to develop new ones.
The Department of Justice has announced its intention to appeal the Fifth Circuit’s decision to the Supreme Court. If the Supreme Court affirms the Fifth Circuit’s ruling, mifepristone would once again be subject to the restrictions on use that were in effect before 2016. Those restrictions would limit the use of mifepristone through seven weeks’ gestation (down from the current limit of 10 weeks), require patients to attend three in-person office visits (prohibiting telehealth-based prescribing), require the supervision of a qualified physician (thereby restricting dispensing in the pharmacy), and require the reporting of all adverse events from mifepristone.