A federal judge in Virginia has declared illegal a requirement from President Joe Biden’s administration that mandated special certification for doctors and pharmacies to prescribe the abortion medication mifepristone.
U.S. District Judge Robert Ballou, presiding in Charlottesville, Virginia, stated on Thursday that the U.S. Food and Drug Administration (FDA) failed to justify the necessity of the 2023 requirements, especially given its repeated affirmations of mifepristone’s safety and effectiveness.
“Nor does the FDA explain how, without these restrictions, prescribing the drug becomes an intolerable risk which would require withdrawal of the drug from the market,” wrote Judge Ballou, a Biden appointee.
This ruling stems from a 2023 lawsuit filed by three abortion providers.
While Judge Ballou can compel the FDA to reconsider the rule, he noted federal law does not currently allow him to strike it down. He may, however, invalidate the rule later when addressing separate claims that it infringes upon the providers’ constitutional rights. The FDA, which is conducting a broader safety review of mifepristone under President Donald Trump, did not immediately respond to a request for comment on Friday.
The decision arrives amidst widespread efforts by Republican-led states and anti-abortion organizations to curtail access to mifepristone, a drug central to over 60% of U.S. abortions.
Initially approved by the FDA in 2000, mifepristone’s access has gradually expanded, including a separate Biden-era regulation permitting its prescription and dispensing via mail. The U.S. Supreme Court allowed this mail-order rule to remain in effect in May, pending a legal challenge paused until the FDA concludes its review.
Mifepristone, a component of a two-drug abortion regimen, has become a focal point in the abortion debate since the Supreme Court’s 2022 decision overturning Roe v. Wade, which eliminated the constitutional right to abortion and empowered individual states to impose bans.
The Center for Reproductive Rights, an advocacy group representing the providers in the lawsuit, emphasized the significance of Judge Ballou’s ruling. In a statement, they highlighted that it reinforces mifepristone’s safety and efficacy at a time when its availability is under scrutiny.
Nancy Northup, the group’s president, asserted: “The efforts to restrict it are not about science or safety — they are about making abortion harder to access.”
