Case update: Oral argument was held May 19, 2025.

Summary

Summary

On May 8, 2023, the Center for Reproductive Rights filed a lawsuit in federal district court in Virginia that challenges the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for the abortion medication mifepristone. Mifepristone, part of a two-pill regimen for medication abortion, was first approved in 2000.

Medication abortion is the most commonly used method of abortion in the United States, accounting for 63% of abortions in the country in 2023.

Brought on behalf of independent abortion providers in Virginia, Montana, and Kansas, the lawsuit seeks to eliminate the REMS—a unique set of restrictions that limit the number of providers who prescribe mifepristone and pharmacies that dispense it, and impede patient access to time-sensitive abortion care. 

The REMS require

The REMS require:

1. Mifepristone prescribers to register with the drug manufacturer, thereby deterring some otherwise qualified providers from prescribing the medication because of the fear that registration could expose them to anti-abortion violence or harassment;
2. That pharmacies be specially certified in order to dispense mifepristone and that they maintain copious records; and 
3. Patients to review and sign a counseling form that is duplicative, inaccurate, and confusing, and can be distressing for patients taking mifepristone for miscarriage management because it mandates they acknowledge they “have decided to take mifepristone and misoprostol to end [their] pregnancy.”

About the case

About the case

The case, Whole Woman’s Health Alliance v. FDA, was filed in the Western District of Virginia, Charlottesville Division.

On August 21, 2023, the federal court denied the Center’s request for a preliminary injunction that would have barred the FDA from reinstating significant restrictions on mifepristone in Virginia, Montana and Kansas as the result of orders issued in a separate case. In its ruling in WWH v. FDA, the district court acknowledged the safety and importance of mifepristone.

The lawsuit argues that the FDA’s decision to maintain the REMS violates the federal Administrative Procedure Act because the FDA: 

1. Failed to make the determinations Congress directed it to make before subjecting a medication to a REMS. 
2. Refused to consider evidence that the REMS does not enhance patient safety and the argument that mifepristone is regulated far more restrictively than other drugs that pose similar or more serious risks.

The Center and the FDA have now filed cross-motions for summary judgment that will be fully briefed on March 18, 2025. Oral argument is scheduled for May 19, 2025.

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