A Virginia federal judge on Thursday struck down a 2023 FDA rule that required doctors and pharmacies to obtain special certification to prescribe the abortion drug mifepristone. Judge Robert Ballou ruled the agency failed to consider relevant evidence and the rule’s effects on patients and providers. He ordered the FDA to revisit the certification requirement as it conducts a broader safety review of the medication.
Virginia Judge Vacates Biden-Era Rule Requiring Special Certification To Prescribe Mifepristone
Demonstrators carry a banner during the annual "March for Life" in Washington, D.C., U.S., January 23, 2026. REUTERS/Kylie Cooper
July 24 — A federal judge in Charlottesville, Virginia, has invalidated a 2023 regulation that required doctors and pharmacies to obtain special certification to prescribe the abortion medication mifepristone. U.S. District Judge Robert Ballou found that the U.S. Food and Drug Administration (FDA) did not adequately justify the change or properly consider relevant evidence and the rule’s potential impact on patients and medical providers.
Judge Ballou ruled in favor of three abortion providers who challenged the certification requirement and ordered the FDA to reconsider the rule. The decision comes while the FDA is conducting a separate, broader safety review of mifepristone.
The ruling does not itself resolve the wider safety questions about the drug; rather, it focuses on the administrative process the agency used when adopting the 2023 certification requirement. The court determined that the agency failed to weigh important data and consider how the rule would affect access to care.
Background: Mifepristone is an FDA-approved medication commonly used in medication abortions. The 2023 rule had imposed special certification standards for prescribers and pharmacies, a requirement the court found insufficiently justified in the agency’s rulemaking record.
Reporting by Daniel Wiessner in Albany, New York; editing by Nick Zieminski.
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