Federal judge rules FDA abortion pill restrictions unlawful, orders review
5 verified4 unconfirmed1 contested
A federal judge in Virginia ruled that the U.S. Food and Drug Administration failed to justify restrictions placed on the abortion medication mifepristone in 2023. The ruling orders the FDA to reconsider those restrictions, which the judge found to be arbitrary and unlawful. The lawsuit was filed in 2023 by abortion providers in Kansas, Montana and Virginia, who argued the restrictions were medically unnecessary. The decision adds to a growing number of legal challenges over mifepristone access, with a separate case pending in the 5th U.S. Circuit Court of Appeals involving Louisiana. The FDA has said it is conducting a broader safety review of the drug. Abortion pills now account for nearly two-thirds of all abortions in the United States, and decades of studies have indicated the safety and effectiveness of mifepristone.
What’s verified
U.S. District Judge Robert Ballou ruled that the FDA’s 2023 restrictions on mifepristone were arbitrary and unlawful, and ordered the agency to reconsider them.
The restrictions include requirements for special certification of prescribing pharmacies and clinicians, and for patients to sign a form acknowledging the medication’s risks.
The lawsuit was filed in 2023 by abortion providers in Kansas, Montana, and Virginia, represented by the Center for Reproductive Rights.
The FDA is conducting a broader safety review of mifepristone, which the agency says has been pushed by conservative lawmakers and activists.
A separate case in the 5th U.S. Circuit Court of Appeals involving Louisiana is considering whether to block telehealth prescriptions of mifepristone.
Where accounts differ
The sources disagree on the day of the ruling: one source states the ruling was issued on Friday, while another states it was issued on Thursday.
Not yet confirmed
One source reports that the Trump administration told the Wall Street Journal the FDA’s safety review is expected to take about six months, concluding after the 2026 midterm elections.
One source notes that a similar case in Hawaii was decided in October 2025, with a federal judge also finding the restrictions arbitrary.
One source reports two additional pending cases: one in Missouri joined by Idaho and Kansas seeking to restore 2016-level restrictions, and another in Texas joined by Florida seeking to revoke mifepristone’s approval entirely.
The exact timeline for the FDA’s compliance with the order was not specified by the judge.
Key figures
Robert Ballou, U.S. District Judge in Virginia
Amy Hagstrom Miller, president and CEO of Whole Woman’s Health Alliance
Nancy Northup, president and CEO of the Center for Reproductive Rights
Sources: The Guardian, stateline.org
