Abortion Providers Fight Back Against FDA’s Last Mifepristone Restrictions in Court

CHARLOTTESVILLE, Va. — Abortion pills returned to federal court on Monday, focusing on their safety and availability. This time, the lawsuit was filed by abortion providers rather than anti-abortion activists. They argue that existing restrictions on the medication effectively restrict access despite mifepristone’s 25-year history of safety and efficacy.

The lawsuit aims to eliminate several restrictions imposed by the U.S. Food and Drug Administration (FDA) on the mifepristone-misoprostol regimen, which was first approved in 2000. Although the FDA has rolled back some provisions of its drug safety program known as Risk Evaluation and Mitigation Strategy (REMS), full deregulation has yet to occur.

Linda Goldstein, senior counsel for the Center for Reproductive Rights, represented independent providers from Virginia, Montana, and Kansas. She argued that the FDA has not adequately reassessed whether these restrictions are still medically necessary. Goldstein emphasized that the risks associated with mifepristone, such as serious bleeding and infection, are not unique to the drug; they apply to all pregnancy terminations, including spontaneous miscarriages.

“The FDA has acknowledged that staying pregnant is more dangerous than not staying pregnant,” she stated, calling for the FDA to clarify why similar-risk drugs do not face equivalent restrictions.

Goldstein pointed out that among the 20,000 drugs approved by the FDA, only 73 are subject to REMS. Mifepristone has been used safely by approximately 7.5 million patients in the U.S. Since its approval, 36 patient deaths associated with the drug have been reported as of December 2024.

The case, Whole Woman’s Health Alliance v. FDA, is notable as it marks the first time the U.S. Department of Justice has taken a position on mifepristone since the Trump administration. DOJ attorney Noah Katzen defended the current regulations as necessary for ensuring the safety of the common abortion method. However, he refrained from confirming if the FDA still regards mifepristone as safe and effective overall.

“That is what the FDA determined in the past,” Katzen remarked during the hearing held in Charlottesville’s U.S. District Court.

U.S. District Judge Robert S. Ballou, appointed by President Joe Biden, appeared receptive to the plaintiffs’ view that some of the restrictions seem arbitrary, especially as they do not apply to other equivalently risky medications.

Ballou did not issue a ruling at the end of the hearing but promised to do so promptly.

Amy Hagstrom Miller, founder of Whole Woman’s Health Alliance, expressed concern over Katzen’s non-committal phrasing about the FDA’s stance on mifepristone’s safety.

This lawsuit is part of a broader landscape of federal cases involving mifepristone. Earlier this month, a brief was filed in Missouri v. FDA, where the Trump administration sought to dismiss a lawsuit from three states aiming to restrict the drug on procedural grounds while avoiding a direct comment on its merit.

While the Missouri case seeks to reinstate regulations loosened between 2016 and 2021, the Whole Woman’s Health case targets burdensome restrictions such as requiring prescribing medical professionals to register with the drug manufacturer and patients to sign counseling forms.

Goldstein argued that these regulations inhibit access to mifepristone by limiting the number of providers and pharmacies, ultimately compromising timely medical care.

She highlighted the politically charged atmosphere surrounding mifepristone and noted that opponents are pursuing either the revocation of the drug’s FDA approval or a return to stringent dispensing requirements.

Since the overturning of Roe v. Wade in 2022, anti-abortion groups have intensified efforts to portray abortion pills as hazardous, aiming to have them heavily regulated or removed from the market.

Last week, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced intentions to direct the FDA to re-evaluate abortion pill safety following a controversial anti-abortion analysis, which has been criticized by reproductive health scientists.

Hagstrom Miller referred to the current restrictions as “politically motivated,” emphasizing the importance of overturning them for Virginia, a state witnessing increased patient travel for abortion services.

“These restrictions are not based on medication safety,” she asserted. “We aim to protect access to the most popular abortion method in Virginia and beyond, regardless of political changes.”

Virginia’s legislature is currently considering a constitutional amendment to safeguard abortion rights, which will face a re-vote next year and hinges on the results of competitive House elections.

As Virginia asserts its role in the South regarding abortion access, Hagstrom Miller underscored the necessity of maintaining safe access to medication abortion for all residents.