Articles and Blogs

UPDATE: Shortly after this alert was published, the Supreme Court granted an administrative stay of the Fifth Circuit’s order. This means that, while the Supreme Court reviews Danco’s and GenBioPro’s emergency requests that the Fifth Circuit’s stay be vacated, mifepristone is available under the 2023 REMS, which permits dispensing of mifepristone directly to patients by... READ MORE

On June 13, 2024, the Supreme Court of the United States unanimously rejected a challenge to the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name “Mifeprix”), a drug used in medically induced abortions. In a 9-0 decision delivered by Justice Brett Kavanaugh, the Supreme Court held that the plaintiffs,... READ MORE

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a... READ MORE

On January 3, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”). The updated Mifepristone... READ MORE