Judge Pauses Mifepristone Lawsuit as FDA Review Looms

US District Judge Reed O'Connor denied a motion to dismiss the case brought by Texas and Florida, but agreed to stay proceedings until December 1. This pause aligns with an ongoing federal review of the drug, led by Health and Human Services Secretary Robert F. Kennedy Jr. While the FDA has consistently maintained that mifepristone is safe, with hospitalization rates ranging between 0.04% and 0.6%, the administration has signaled that the current review could result in substantive changes to how the medication is dispensed.

GenBioPro, which manufactures generic mifepristone, remains a primary party in the defense of the drug's approval. CEO Evan Masingill stated that the company expects the review to uphold the scientific consensus established in 2023. Even if the current litigation fails to overturn the drug's approval, the administration retains the authority to curtail access by reinstating in-person requirements or limiting pharmacy distribution. Skye Perryman, CEO of Democracy Forward, characterized the administration's pressure as an ideologically-driven attempt to bypass established safety standards.