Abortion Providers Take on FDA: Legal Fight Over Mifepristone Restrictions Heats Up

Abortion pills and the ongoing debate over their safety returned to federal court Monday. This time, the plaintiffs are abortion providers seeking to eliminate remaining restrictions, rather than anti-abortion activists. The aim is to improve access to the mifepristone-misoprostol regimen, which has a 25-year history of safety and efficacy.

The lawsuit challenges current limitations on the U.S. Food and Drug Administration’s (FDA) approval of the drug, established under the Drug Safety Program known as Risk Evaluation and Mitigation Strategy (REMS). Some restrictions have been lifted over time, yet many remain.

Linda Goldstein, senior counsel at the Center for Reproductive Rights, represents independent providers in Virginia, Montana, and Kansas. She contended that the FDA’s latest evaluations inadequately addressed the necessity of existing restrictions. According to Goldstein, the significant risks identified with mifepristone—such as serious bleeding and infection—are not unique to this medication; they also occur with all pregnancy terminations, including spontaneous miscarriages.

Goldstein emphasized that the FDA has recognized the dangers of remaining pregnant outweigh the risks associated with termination. She argued that the FDA must justify why similar medications face different regulations.

Out of 20,000 approved drugs, only 73 have REMS provisions, and mifepristone has been shown to be safe for about 7.5 million U.S. patients since its approval. As of December 2024, there have been 36 reported deaths linked to the drug since its introduction.

The Whole Woman’s Health Alliance v. FDA case marks the first instance where the U.S. Department of Justice has taken a stance on mifepristone since the Trump administration. DOJ attorneys maintain that current regulations are vital to ensure the safety of the most common form of pregnancy termination. When scrutinized, DOJ attorney Noah Katzen refrained from confirming whether the FDA still regards mifepristone as safe and effective overall.

At a hearing in the U.S. District Court for the Western District of Virginia, Judge Robert S. Ballou, appointed by President Biden, exhibited sympathy for the argument that some restrictions seem arbitrary compared to other drugs with similar risks. Ballou indicated he would deliver a ruling soon after the hearing.

Afterward, Amy Hagstrom Miller, founder and president of Whole Woman’s Health Alliance, noted the implications of Katzen’s remarks regarding the drug’s safety. This lawsuit is one of several federal cases concerning mifepristone. Earlier this month, the Trump administration attempted to dismiss states’ lawsuits aimed at restricting the drug on procedural grounds.

Unlike Missouri v. FDA, which seeks to reinstate regulations relaxed between 2016 and 2021, the Whole Woman’s Health v. FDA lawsuit is focused on eliminating burdensome measures like the registration of prescribers and the requirement for pharmacies to get special certification. These regulations limit provider access and complicate patient care.

Goldstein pointed to the political environment affecting mifepristone, highlighting conservative efforts to restrict access through various means, including the organizational playbook Project 2025 from the Heritage Foundation.

Since the rollback of Roe v. Wade in 2022, anti-abortion groups have argued that abortion pills pose substantial risks that justify pulling them from the market. During his campaign and tenure, President Trump has exhibited contradictory messages regarding medication abortion, promising access while showing openness to reevaluating its safety.

Recent statements from U.S. Health and Human Services Secretary Robert F. Kennedy Jr. indicated the potential for an FDA review of abortion pill safety, following critique of an influential anti-abortion white paper that contradicts numerous studies documenting low rates of severe adverse events.

Hagstrom Miller described current restrictions as politically driven, stating that their repeal would be crucial for Virginia, which already sees many outsiders seeking care due to its comparatively lenient laws. The state is in the process of amending its constitution to protect abortion and related healthcare procedures.

This amendment recently passed the legislature but requires another vote next year before reaching the ballot. The outcome depends significantly on forthcoming House of Delegates elections, in which Democrats hold a slim majority. Future governance could either bolster or undermine ongoing reproductive rights in Virginia.

“It’s crucial that we ensure safe access to medication abortion, regardless of geographic location—Virginia is pivotal in this context,” Hagstrom Miller stated.