science
Federal Judge Denies Request to Block Mail Delivery of Abortion Pill Pending FDA Review
A U.S. federal judge declined to halt the mailing of the abortion pill mifepristone for now. The ruling requires the Food and Drug Administration to complete its review of the drug's safety and access protocols. The decision stems from a lawsuit challenging FDA approvals.
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A federal judge in Texas ruled on Wednesday that the Food and Drug Administration may continue allowing the mailing of the abortion pill mifepristone while a lawsuit challenging its regulatory approvals proceeds. The decision came in response to a request from anti-abortion groups seeking an immediate block on mail-order distribution.
The judge, Matthew Kacsmaryk, stated that the FDA must finalize its ongoing review of the drug's risk evaluation and mitigation strategy.
The lawsuit, filed by the Alliance for Hippocratic Medicine and other plaintiffs, argues that the FDA improperly relaxed restrictions on mifepristone in 2016 and 2021. Those changes expanded access by allowing prescriptions via telehealth and delivery by mail without an in-person visit. The case affects approximately 5 million prescriptions issued since the drug's approval in 2000.
Legal Challenge Mifepristone, used in combination with misoprostol, accounts for more than half of U.S. abortions. The plaintiffs contend that expanded access increases risks of complications, such as excessive bleeding, and violates federal law. The FDA maintains that the changes are supported by extensive safety data from millions of uses.
The ruling preserves current access for patients in states where abortion remains legal, including through mail from providers like those certified under the FDA's program. It impacts women seeking medication abortions, particularly in rural areas or states with limited clinic availability.
The decision does not resolve the broader lawsuit, which could lead to further restrictions if the plaintiffs prevail.
in the Case The FDA has been directed to complete its review by a specified deadline, though exact timing was not detailed in the ruling.
Both sides may appeal aspects of the order. The case is part of ongoing litigation following the Supreme Court's 2022 Dobbs decision, which overturned Roe v. Wade and shifted abortion regulation to states.
