A federal judge in Virginia has ruled that certain Biden-era abortion drug restrictions are unlawful. U.S. District Judge Robert Ballou declared that the U.S.
Food and Drug Administration (FDA) failed to justify the necessity of the 2023 requirements for special certification for doctors and pharmacies to prescribe the abortion medication mifepristone. Judge Ballou stated that the FDA repeatedly affirmed mifepristone’s safety and effectiveness, yet the agency did not explain how the restrictions were necessary to mitigate risks. The ruling stems from a 2023 lawsuit filed by three abortion providers, and while Judge Ballou cannot strike down the rule, he may invalidate it later when addressing separate claims that it infringes upon the providers’ constitutional rights.
The FDA is conducting a broader safety review of mifepristone, and the agency did not immediately respond to a request for comment. 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. Mifepristone has been a focal point in the abortion debate since the Supreme Court’s 2022 decision overturning Roe v.
Wade. 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. The Center for Reproductive Rights, an advocacy group representing the providers in the lawsuit, emphasized the significance of Judge Ballou’s ruling. The group’s president, Nancy Northup, asserted that the efforts to restrict mifepristone are not about science or safety, but about making abortion harder to access.
The ruling reinforces mifepristone’s safety and efficacy at a time when its availability is under scrutiny.
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