By Daniel Wiessner
July 24 (Reuters) – A federal judge in Virginia has ruled that it was illegal for former President Joe Biden’s administration to require doctors and pharmacies to be specially certified to prescribe the abortion drug mifepristone.
U.S. District Judge Robert Ballou in Charlottesville, Virginia, on Thursday said the U.S. Food and Drug Administration had failed to explain why the requirements adopted in 2023 were necessary after the agency had repeatedly affirmed 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 Ballou, who was appointed by Biden, a Democrat.
The decision came in a lawsuit that three abortion providers filed in 2023. Ballou could strike down the rule later on when he rules on separate claims that it violated the providers’ constitutional rights.
Ballou said federal law permitted him to order the FDA, which under Republican President Donald Trump is conducting a broader review of mifepristone’s safety, to reconsider the rule but not to strike it down.
The FDA did not immediately respond to a request for comment on Friday.
The decision comes as Republican-led states and anti-abortion groups are fighting on multiple fronts to limit access to mifepristone, which is used in more than 60% of U.S. abortions.
The FDA initially approved mifepristone in 2000 and has expanded access over time, including in a separate Biden-era rule allowing the drug to be prescribed and dispensed through the mail. The U.S. Supreme Court in May allowed that rule to remain in effect pending a legal challenge that has been paused until the FDA completes its review.
Access to mifepristone, which is part of a two-drug abortion regimen, has become a flashpoint in the abortion debate since the U.S. Supreme Court’s 2022 decision overturning Roe v. Wade, which had recognized a constitutional right to abortion, paving the way for individual states to ban the procedure.
The Center for Reproductive Rights, an abortion rights group that represents the providers who sued over the 2023 rule, in a statement said Ballou’s ruling was significant because it underscores that mifepristone is safe and effective at a time when access to the drug is being tested.
“The efforts to restrict it are not about science or safety — they are about making abortion harder to access,” said Nancy Northup, the group’s president.
(Reporting by Daniel Wiessner in Albany, New York; Editing by Nick Zieminski, Alexia Garamfalvi and Andrea Ricci )
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