A United States court has ordered the Trump administration to review restrictions placed on the abortion pill mifepristone, ruling that the requirements imposed by the Food and Drug Administration (FDA) were unlawful.
The decision, delivered by Judge Robert S. Ballou of the Federal District Court in Virginia, followed a lawsuit filed by the Centre for Reproductive Rights in May 2023 on behalf of abortion providers in Virginia, Kansas and Montana.
The challenge targeted the FDA’s Risk Evaluation and Mitigation Strategy (REMS), a set of rules that abortion rights advocates have long argued places unnecessary barriers on access to the medication.
The requirements include mandatory registration of prescribers with the drug manufacturer, certification for pharmacies dispensing the drug and compulsory patient counselling before treatment.
In his ruling, Ballou said the restrictions were arbitrary because the FDA has consistently maintained for more than two decades that mifepristone is a safe and effective medication.

While the judge directed the administration to reconsider the regulations, he stopped short of striking them down or ruling that the FDA lacked the authority to impose safety measures.
The Centre for Reproductive Rights welcomed the decision, describing it as a victory for science.
“This ruling is a win for science,” said Nancy Northup, CEO at the Center for Reproductive Rights.
The case is separate from another legal challenge before the Fifth Circuit Court of Appeals, where the Republican-led state of Louisiana is seeking to restore restrictions that would prevent patients from receiving mifepristone through the mail or from pharmacies after virtual consultations.
In May, the US Supreme Court temporarily preserved mail access to the drug by extending a stay on the Fifth Circuit’s earlier order while the case proceeds.
Approved by the FDA in 2000, mifepristone is used alongside another medication to terminate pregnancies and is also commonly prescribed to manage miscarriages.
The drug accounted for about 63 per cent of abortions in the United States in 2023.
Meanwhile, the FDA has launched a separate review of regulations governing access to abortion pills.
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