A three-judge panel of appellate judges has partially concurred with a lower court decision placing access limits on the abortion drug mifepristone, though the change will not go into effect until the Supreme Court decides whether it wants to make the final call.
The U.S. Court of Appeals for the Fifth Circuit’s decision, delivered Wednesday afternoon, vacated that lower court’s broader order that would have nullified the drug’s Food and Drug Administration [FDA] approval in 2000 as well as the subsequent approval of its generic version.
“This means that, until final judgment, Mifeprex [mifepristone] will remain available to the public under the conditions for use that existed in 2016,” Justice Jennifer Walker Elrod wrote in the order. “… The generic version of mifepristone will also be available under the same conditions as Mifeprex.”
However, the judges affirmed the lower court’s order related to subsequent regulatory actions that are generally related to mail-order prescriptions, finding merit in plaintiffs’ argument that the agency overlooked safety risks when changes to its risk evaluation and management strategy allowed broader access to the drug.
“In loosening mifepristone’s safety restrictions [with its 2016 Amendments and 2021 Non-Enforcement Decision], FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Elrod wrote.
The decision is the latest stemming from a controversial order from U.S. District Court for the Northern District of Texas Judge Matthew Kacsmaryk regarding a lawsuit brought by the anti-abortion provider group Alliance for Hippocratic Medicine, which would have rescinded the FDA’s approvals.
Pending an appeal from the Biden administration, a divided Fifth Circuit Court of Appeals allowed the drug to stay on the market with similar restrictions to its most recent ruling. The Supreme Court later issued a 7-2 emergency order that maintained mifepristone’s current access through the end of the appeals process.
Due to the Supreme Court’s order, the appellate court’s latest ruling won’t go into effect unless the Supreme Court declines to have a final say—though all signs point toward another chapter in the highly watched legal battle.
More than half of abortions in the U.S. rely on mifepristone. Prescriptions for it and misoprostol, another abortion-inducing drug, have increased following the conservative-led Supreme Court’s decision to overturn Roe v. Wade and recent restrictions enacted by several states’ legislatures. The lower court’s Kacsmaryk and the three Fifth Circuit judges are each Republican appointees.
In prior filings, mifepristone manufacturer Danco, the Biden administration and other healthcare and pharmaceutical groups argued that rescinding the decades-old regulatory approval would cause “untenable limbo” for the industry, place prescribing providers in legal gray areas and generally undermine the authority of the FDA.
James C. Ho, one of the three Fifth Circuit judges, dissented in part with Wednesday’s partial affirmation. In a separate opinion, he said he would also roll back the 2000 regulatory approval as not in accordance with Congress’ Administrative Procedure Act and the Comstock Act, which are bolstered by last year’s Dobbs decision.
He also critiqued the industry and administration’s support for the FDA, noting that the agency and its scientists have “made plenty” of mistakes over the years when approving drugs with safety concerns and should not be viewed as infallible and more substantive than those of elected representatives.
“The scientists at the FDA deserve our respect and our gratitude, but not our blind deference,” Ho wrote. “That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the APA.”