Virginia Judge Blocks Biden-Era Certification Requirement for Mifepristone Prescriptions

On July 24, U.S. District Judge Robert Ballou in Charlottesville, Virginia, ruled that the 2023 requirement mandating special certification for doctors and pharmacies to prescribe the abortion medication mifepristone was illegal. Ballou held that the U.S. Food and Drug Administration (FDA) had not demonstrated why the rule was necessary, given its repeated affirmations of the drug’s safety and effectiveness. He noted that federal law permits him to order the FDA to reconsider the rule but does not allow him to strike it down outright; the rule could be invalidated later when he addresses separate constitutional-rights claims raised by the plaintiffs.

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Mifepristone was first approved by the FDA in 2000 and has since become a core component of a two-drug regimen used in more than 60 % of abortions in the United States. After the Supreme Court’s 2022 decision overturning *Roe v. Wade*, individual states began enacting bans, and the drug emerged as a flashpoint in the national abortion debate. In 2023, the Biden administration issued a rule requiring doctors and pharmacies to obtain special certification before prescribing mifepristone, citing a need to protect public health. The rule was challenged by three abortion providers. In May, the Supreme Court allowed a separate Biden-era mail-order rule for the drug to remain in effect while the FDA conducts a broader safety review under the Trump administration.

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The FDA did not immediately respond to a request for comment. The Center for Reproductive Rights, representing the suing providers, said the decision underscores mifepristone’s safety and efficacy at a time when its availability is under scrutiny. Nancy Northup, president of the Center, argued that the attempts to restrict the drug are driven by a desire to make abortion harder to access rather than by scientific concerns.

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• Mifepristone is used in over 60 % of U.S. abortions.

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• The drug is part of a two-drug regimen, the other component being misoprostol.

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• The 2023 certification rule applied nationwide to doctors and pharmacies that dispense the medication.

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• “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,” — Robert Ballou, district judge

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