A federal judge ruled Friday that the Food and Drug Administration (FDA) unjustly restricted the abortion pill mifepristone in recent years, finding that the agency failed to conduct an adequate review before implementing new requirements.
U.S. District Judge Robert Ballou of the Western District of Virginia stated that the Risk Evaluation and Mitigation Strategies (REMS) modifications were "arbitrary and capricious," noting that the FDA has consistently affirmed mifepristone's safety and effectiveness for over two decades. The judge directed the FDA to reconsider its restrictions but did not remove them, concluding that the current measures violate the equal protection rights of mifepristone prescribers and patients by treating them differently than those involved with any other FDA-approved drug.
In 2023, the FDA maintained requirements that pharmacies and clinicians prescribing mifepristone must be specially certified, and that patients and their doctors must sign a form acknowledging the treatment and its risks. Abortion providers in Virginia, Kansas, and Montana filed suit to challenge these specific requirements.
Plaintiffs hailed the ruling as a victory for science-driven healthcare policy. Kathryn Sanders of Blue Mountain Clinic in Montana stated that removing these "unnecessary barriers" would help ensure pregnant individuals can access timely and dignified care, thereby protecting and strengthening access to medication abortion.
The FDA first approved mifepristone in 2000. Over the past two decades, the agency has eased some restrictions, including a 2021 decision that allowed mail-order pharmacies to dispense the pill, citing concerns that the COVID-19 pandemic could impede patient access to care. The practice of sending abortion pills by mail has faced legal challenges from several Republican-led states, though the Supreme Court ruled in May that it may continue during ongoing lower court proceedings.
Separately, a panel of Fifth Circuit judges is scheduled to hear arguments in a case brought by Louisiana, which seeks to reinstate prior FDA restrictions that would prevent patients from obtaining mifepristone by mail or from pharmacies. The Center for Reproductive Rights characterized Friday's ruling as a "win for science," asserting that attempts to restrict mifepristone are politically motivated rather than based on safety concerns, and that the drug is "exceedingly safe."