Mifepristone restrictions ruling sends FDA rules back for review
A Virginia federal judge found mifepristone access rules unlawful but left them in place while the Trump administration reconsiders them.
By Tom Brennan · Health & Medicine Correspondent
3 min read
A mifepristone restrictions ruling from a federal court in Virginia has found several FDA access rules for the abortion pill unlawful, while leaving them in effect for now. AFP reported that Judge Robert S. Ballou ordered the Trump administration to take another look at the rules, a decision that could affect how prescribers, pharmacies and patients handle the medication.
The case was filed in May 2023 by the Center for Reproductive Rights, according to AFP. The group brought the challenge on behalf of abortion providers in Virginia, Kansas and Montana.
The dispute centers on the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy, or REMS, for mifepristone. REMS programs are FDA safety rules applied to some drugs when the agency requires extra controls on prescribing, dispensing or patient information.
What did the court say about mifepristone restrictions?
In an order entered Thursday and publicized Friday, Judge Ballou said the challenged restrictions were “arbitrary and capricious,” AFP reported. The judge wrote that the FDA has repeatedly found over 25 years that mifepristone is safe and effective.
The ruling did not erase the rules immediately. AFP reported that Ballou also did not rule that the FDA lacked authority in principle to impose safety restrictions on mifepristone.
The judge instead directed the Trump administration to reconsider the policy. That keeps the current framework in place while the administration and the FDA address the court’s findings.
Which rules were challenged?
AFP reported that abortion rights advocates have long criticized the REMS requirements as burdensome. One rule requires prescribers to register with the drug’s manufacturer, which advocates say creates a national database that could endanger doctors.
Another requirement makes pharmacies obtain special certification and keep detailed records, according to AFP. A third requires patients to review counseling material that critics described as inaccurate.
Nancy Northup, chief executive of the Center for Reproductive Rights, called the decision “a win for science,” AFP reported.
How does this fit into other abortion pill cases?
The Virginia case is separate from a fight now before the 5th U.S. Circuit Court of Appeals, according to AFP. In that case, Louisiana, led by Republicans, is asking the FDA to restore a ban on patients receiving mifepristone by mail or through pharmacies after a virtual appointment with a provider.
AFP reported that the U.S. Supreme Court in May temporarily preserved access to mifepristone by mail. The justices extended a stay blocking a 5th Circuit order that had sided with Louisiana and would have stopped that delivery method.
That appeals court case has returned to the 5th Circuit for full briefing, AFP reported. It may later go back to the Supreme Court.
Mifepristone is one drug in a two-pill medication abortion regimen, according to AFP. The FDA approved it in 2000, and it is also routinely used in miscarriage care.
AFP reported that mifepristone has accounted for 63% of U.S. abortions since 2023. Anti-abortion activists have questioned the drug’s safety, including by pointing to a conservative think tank study that AFP said was not formally peer reviewed.
The FDA has separately ordered its own review of abortion pill regulations, AFP reported.
This story draws on original reporting from Medical Xpress.