Whole Woman’s Health Alliance v. FDA

Case update: The Center and FDA have filed cross-motions for summary judgment that will be fully briefed on March 18, 2025. Oral argument was held May 19, 2025.

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 requires:

• 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;
• That pharmacies be specially certified in order to dispense mifepristone and that they maintain copious records; and 
• 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.”

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

• Failed to make the determinations Congress directed it to make before subjecting a medication to a REMS. 
• 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 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 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.

Plaintiff(s): Whole Woman’s Health clinics in Virginia; Blue Mountain Clinic in Montana; All Families Healthcare and Helen Weems in Montana; and Trust Women in Kansas

Respondent(s): Food & Drug Administration (FDA); Department of Health and Human Services (HHS)

Center Attorney(s): Linda Goldstein, Olivia Roat

Legal documents:

• Defendants’ Reply in Support of Cross-Motion for Summary Judgment, 3.18.25
• Reply to Cross-Motion for Summary Judgment, 02.04.25
• Defendants’ Combined Memorandum in Support of Cross-Motion for Summary Judgment, 12.18.24
• Memorandum of Law in Support of Plaintiffs’ Motion for Summary Judgment, 10.23.24
• Ruling by the Western District of Virginia, Charlottesville Division, 08.21.23
• Complaint for Declaratory and Injunctive Relief, 05.08.23

Case news:

• Center Files Lawsuit to Ensure Access to Abortion Drug in Three States, 05.08.23
• Press release: Abortion Providers Sue FDA to Protect Access to Abortion Pill, 05.08.23

May 08, 2023	The Center files a lawsuit in federal district court in Virginia on behalf of independent abortion providers.
January 12, 2024	Case stayed pending the Supreme Court’s decision in another case against the FDA.
July 12, 2024	Court enters briefing schedule for summary judgment motions.
October 23, 2024	Plaintiffs file motion for summary judgment.
December 18, 2024	Defendants file cross-motion for summary judgment and opposition to the plaintiffs’ motion for summary judgment.
February 05, 2025	Plaintiffs file their reply in support of motion for summary judgment.
May 19, 2025	Oral argument held.