While it is critically important for the nation’s healthcare system and for biomedical research that the Supreme Court’s recent ruling preserved access to mifepristone (Mifeprex) for now, the emergency action fails to ensure FDA’s long-standing regulatory authority and legal status for evaluating and approving new drugs and medical products. In sending the case back to the Fifth Circuit Court of Appeals for further review, the high court’s April 21, 2023 action leaves open the prospect of further rulings that could undermine FDA’s approval process. States where abortion remains legal are stocking up on the pills, and biopharma companies are filing briefs to support FDA’s authority to regulate the development of safe and effective medicines.
