In a recent speech at the National Press Club on February 8, 2024, Xavier Becerra, Secretary of the Department of Health and Human Services (HHS), discussed the far-reaching implications of the upcoming Supreme Court case involving the abortion drug mifepristone. The case, FDA v. Alliance for Hippocratic Medicine, was initially brought to the US District Court for the Northern District of Texas in 2022 by a group of anti-abortion physicians and advocates. They argued that the FDA had not adequately ensured the safety and efficacy of mifepristone before its approval. Although the Fifth Circuit Court of Appeals overturned part of the lower court’s ruling, it imposed restrictions on the distribution of mifepristone, limiting it to prescriptions after in-person consultations and barring mail-order access.
The Supreme Court has paused the Fifth Court’s order and is set to review the case and issue a ruling later this year. Becerra expressed concern that if the Supreme Court finds the FDA’s regulatory review process for mifepristone to be defective, it could trigger further lawsuits challenging the approval of other drugs and medical devices. He emphasized the broader consequences of the decision, suggesting that it could impact a wide range of medical treatments and products that Americans rely on, all of which are approved based on the FDA’s assessment of safety and effectiveness. Becerra expressed hope that the Supreme Court would recognize the decision’s extensive implications and act sensibly.