Virginia Judge Rules FDA’s Mifepristone Restrictions Unjustified

In July 2026, U.S. District Judge Robert S. Ballou in Virginia held that the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) for the abortion medication mifepristone is “arbitrary” and “capricious.” In *Whole Woman’s Health Alliance v. FDA*, the court ordered the agency to revisit three restrictions that require special provider certification, pharmacy certification, and patient-signed consent forms. The ruling follows a lawsuit filed in May 2023 by the Center for Reproductive Rights on behalf of providers in Virginia, Kansas, Montana, and other states.

Talking Points Memo

Mifepristone was approved in 2000 and has been used by more than 7.5 million people in the United States. Medication abortion now accounts for roughly two-thirds of all abortions. After the 2022 overturning of *Roe v. Wade*, several states intensified efforts to limit access. The FDA’s 2023 REMS, instituted under the Biden administration, lifted earlier limits—allowing telehealth prescriptions, certified pharmacy dispensing, and mailing—but retained the three requirements the judge found unsupported by safety data.

Talking Points Memo

• Mortality rate for medication abortion: 0.65 deaths per 100,000 abortions.

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• Mortality rate for penicillin (a drug without REMS): 2 deaths per 100,000 patients.

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• Only 73 of over 20,000 FDA-approved drugs are subject to a REMS.

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Judge Ballou cited these figures to argue that mifepristone’s risk profile does not justify the special controls.

Center for Reproductive Rights

• The Center for Reproductive Rights called the restrictions “politically motivated” and urged the agency to eliminate the barriers.

Center for Reproductive Rights

• The Trump administration, which inherited the case, announced a review of the drug’s safety, described by a former FDA commissioner as being “slow-walked” after the 2024 midterms.

Talking Points Memo

State officials in Louisiana have challenged the 2023 REMS as “too permissive,” claiming it forces the state to cover Medicaid costs for patients hospitalized after taking mifepristone. A Fifth Circuit panel initially sided with Louisiana, but the Supreme Court blocked that decision while the litigation proceeds. Opponents frame the REMS as a safeguard against alleged health risks, despite the judge’s finding that the agency has not demonstrated such risks.

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• “This ruling is a win for science,” — Nancy Northup, Center for Reproductive Rights

Center for Reproductive Rights

• “Mifepristone is incredibly safe, yet it faces restrictions that aren’t even required for high-risk medications, like opioids,” — Linda Goldstein

Center for Reproductive Rights

• “Plaintiffs note that other commonly prescribed drugs, comparable in safety to mifepristone, have been approved without any REMS requirements,” — Judge Ballou

Talking Points Memo

The FDA has been ordered to remand the 2023 REMS for further evaluation. The agency’s forthcoming decision will determine whether the three remaining restrictions stay in place, are modified, or are removed. Parallel litigation, including the Louisiana case and the Center for Reproductive Rights’ suit in Washington, D.C., continues to test the regulatory landscape for medication abortion nationwide.

Talking Points Memo