August 16, 2023court rulingreproductive health policyFDA drug approvalfederal courtsREMSreproductive rightsjudicial powerfederal courts
Fifth Circuit rules to reinstate pre-2016 mifepristone restrictions
A Fifth Circuit panel of Judges Jennifer Walker Elrod, James Ho, and Cory Wilson issued a merits ruling upholding the FDA's 2000 mifepristone approval on statute-of-limitations grounds but ordering the reinstatement of pre-2016 REMS restrictions, including the seven-week gestational limit, in-person dispensing requirement, and physician-only prescribing. Judge Ho wrote separately to argue the 2000 approval itself was unlawful. The April 2023 Supreme Court stay kept the ruling from taking immediate effect, preserving current access while the case headed to the Supreme Court.