A United States federal court has ruled that restrictions imposed by the Food and Drug Administration on the prescription and dispensing of the abortion drug mifepristone were unlawful, ordering the agency to reconsider whether the requirements should remain in place.
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US District Judge Robert S. Ballou of the Western District of Virginia held that the FDA failed to adequately explain why doctors and pharmacies must obtain special certification before prescribing or dispensing the medication, despite the agency’s repeated findings that mifepristone is safe and effective.
The ruling was delivered on Thursday, July 23, 2026, in Whole Woman’s Health Alliance and Others v. United States Food and Drug Administration and Others, a lawsuit filed by abortion providers challenging the FDA’s continuing regulation of the drug.
Judge Ballou described the FDA’s decision to retain the restrictions as arbitrary and capricious, finding that the agency had not sufficiently connected its scientific findings about the medication’s safety to the need for the special requirements.
The judge observed that the FDA had consistently regarded mifepristone as safe and effective during its reviews of the drug over the past 25 years.
He further held that the agency failed to explain how removing the restrictions would make prescribing the drug so dangerous that mifepristone would have to be withdrawn from the market.
The court did not immediately cancel the restrictions. Instead, it returned the matter to the FDA and directed the agency, now operating under President Donald Trump’s administration, to review the rules and determine whether they should be removed or modified.
Consequently, the existing certification and documentation requirements remain operational while the FDA conducts its reconsideration, unless the court grants additional relief at a later stage.
Judge Ballou said the applicable federal law empowered him to order the FDA to reconsider its decision but did not, at this stage of the proceedings, permit him to simply invalidate the regulations.
The court may still consider separate claims alleging that the restrictions violate the constitutional rights of the healthcare providers who brought the lawsuit. A subsequent ruling on those claims could lead to further orders against the FDA. (Reuters)
The challenged requirements form part of the FDA’s Risk Evaluation and Mitigation Strategy for mifepristone. Under the programme, healthcare professionals seeking to prescribe the medication must complete a special certification process.
Pharmacies must also be specially certified before dispensing the drug, while patients are required to review and sign a Patient Agreement Form acknowledging that they have received information and counselling concerning the medication.
Mifepristone may be supplied only by, or under the supervision of, a certified prescriber or through a certified pharmacy acting on a prescription issued by an approved provider.
The lawsuit was filed in May 2023 by the Center for Reproductive Rights on behalf of Whole Woman’s Health Alliance, which operates in Virginia and other states; All Families Healthcare and Blue Mountain Clinic in Montana; and Trust Women in Kansas.
The providers argued that the restrictions created unnecessary administrative barriers, reduced the number of healthcare professionals and pharmacies willing to offer mifepristone, and delayed access to time-sensitive medical services.
They specifically asked the court to remove the special registration requirements for prescribers and pharmacies, as well as the mandatory Patient Agreement Form.
The FDA initially approved mifepristone in 2000 for use with misoprostol to terminate an intrauterine pregnancy. The approved regimen may be used through the first 10 weeks of pregnancy.
The agency has gradually modified the rules governing the drug. It removed the requirement for patients to collect mifepristone in person and later permitted certified retail and mail-order pharmacies to dispense it, while retaining the special certification and patient documentation requirements.
Mifepristone has become the most widely used method of abortion in the United States and is reportedly involved in more than 60 per cent of abortions carried out nationwide.
The legal status of the medication has remained a major subject of political and judicial dispute since the US Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and ended the federal constitutional right to abortion.
That ruling allowed individual states to introduce or enforce their own abortion restrictions, prompting several Republican-led states and anti-abortion organisations to pursue legal efforts aimed at limiting access to mifepristone.
The Trump administration is separately conducting a broader review of the medication’s safety and existing regulatory framework. The FDA did not immediately issue a public response to Judge Ballou’s ruling.
The decision also comes amid a separate legal battle over whether mifepristone may continue to be prescribed through telemedicine and delivered by mail.
In May 2026, the US Supreme Court allowed the FDA’s mail-distribution rules to remain effective while another challenge involving Louisiana was placed on hold pending the agency’s wider review.
Reacting to the Virginia ruling, the Center for Reproductive Rights described the judgment as a victory for science and argued that the regulations were motivated by political opposition to abortion rather than genuine safety concerns.
Its president, Nancy Northup, said the ruling was significant at a time when mifepristone faced growing legal and political challenges across the country.
The judgment does not prevent US states from enforcing abortion bans or restrictions within their jurisdictions. Its immediate effect is limited to requiring the FDA to reconsider the federal certification and documentation conditions attached to mifepristone.
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