A federal court in the United States has ruled that restrictions imposed on the abortion pill mifepristone by the Food and Drug Administration (FDA) are unlawful and has directed the Trump administration to reconsider the regulations.
The ruling was delivered by Judge Robert S. Ballou of a federal court in Virginia in a case filed by the Center for Reproductive Rights on behalf of abortion providers in Virginia, Kansas and Montana.
The lawsuit challenged a set of restrictions known as the Risk Evaluation and Mitigation Strategy (REMS), which abortion rights advocates have argued are unnecessarily burdensome despite the drug’s long-established safety record.
Among the disputed measures is a requirement that healthcare providers prescribing mifepristone register with the drug’s manufacturer, creating a national database that critics say could expose doctors to safety and privacy risks.
Other restrictions require pharmacies dispensing the medication to obtain special certification and maintain extensive records, while patients must review counselling materials that advocates contend contain misleading information.
In his ruling, Judge Ballou stated that the restrictions were “arbitrary and capricious,” noting that the FDA had consistently maintained over the past 25 years that mifepristone is a safe and effective medication.
The court, however, stopped short of immediately cancelling the restrictions and did not rule that the FDA lacked the authority to impose safety measures. Instead, it ordered the agency to reassess the regulations in light of available scientific evidence.
Reacting to the decision, President and Chief Executive Officer of the Center for Reproductive Rights, Nancy Northup, described the judgment as a victory for science and evidence-based healthcare.
“This ruling is a win for science,” Northup said.
The case is separate from another ongoing legal challenge in the Fifth Circuit Court of Appeals, where the State of Louisiana is seeking the reintroduction of restrictions preventing patients from receiving mifepristone by mail or through pharmacies after virtual consultations with healthcare providers.
In May, the United States Supreme Court temporarily preserved access to the medication through mail delivery while the appeals process continues.
Mifepristone, approved by the FDA in 2000, is used in combination with another medication to terminate pregnancies and is also commonly prescribed for miscarriage management. According to available data, medication abortion accounted for approximately 63 per cent of all abortions in the United States in 2023.
The FDA has separately launched its own review of abortion pill regulations as legal and political debates over reproductive healthcare continue across the country.
