Attorney General Tong Leads Multistate Push to End FDA’s Unnecessary Restrictions on Mifepristone

Attorney General William Tong’s recent petition to the FDA to lift restrictions on mifepristone is part of a sweeping multistate legal strategy to secure reproductive rights in the post-Dobbs landscape. To unpack this fully, we need to look at both the press release summary and the detailed Citizen Petition filed with the FDA.

Mifepristone, combined with misoprostol, is the most common abortion method in the U.S., accounting for well over 60% of abortions nationwide. Despite its decades-long safety record and FDA approval since 2000, it is still subject to an unusually strict Risk Evaluation and Mitigation Strategy (REMS). These requirements force prescribers and pharmacies to obtain special certification and require patients to sign forms acknowledging they are voluntarily terminating a pregnancy—conditions not imposed on almost any other medication.

What Tong and the coalition argue in the petition:

1. Safety Record: The petition highlights that mifepristone has been used more than 7.5 million times in the U.S. with serious adverse events being extremely rare—less than 0.05%. In fact, the FDA itself acknowledges that there is no causal link between mifepristone and reported deaths.
2. Public Health Data from the States: States provided declarations showing consistently low complication rates. For example, in Connecticut, of more than 6,000 medication abortions in 2021, only three complications were reported, and none were life-threatening. Washington, Pennsylvania, Oregon, and others submitted similar statistics showing complications are typically limited to “retained products of conception,” which is not considered an adverse safety event.
3. Telemedicine Evidence: Multiple states demonstrated that mifepristone abortions via telemedicine had no increase in serious complications—in fact, it greatly improved access in rural and underserved areas.
4. Legal Grounds: Under 21 C.F.R. § 10.30, states can file a Citizen Petition requesting the FDA to revise or eliminate restrictions when they are no longer justified. The coalition argues that continuing the REMS is arbitrary and capricious under the Administrative Procedure Act, since it contradicts overwhelming scientific evidence.
5. Alternative Relief: If the FDA refuses to remove REMS nationally, the petition asks the agency to exercise enforcement discretion and not enforce REMS within petitioner states (like Connecticut), which already have their own regulatory safeguards. This echoes other contexts where FDA has chosen not to enforce drug restrictions when state-level protections are sufficient.

Legal Analysis:
This petition tees up a classic federalism vs. administrative law conflict. States like Connecticut argue they have robust safeguards, making REMS unnecessary and burdensome. At the same time, because REMS are federally imposed, the FDA controls the national standard. If FDA maintains the restrictions, litigation could follow under the APA, with courts asked to determine whether the agency’s continued burdens are “arbitrary and capricious.”

The petition also draws from post-Dobbs dynamics. With abortion rights stripped from the federal Constitution, “safe haven” states are building layered protections. By attacking REMS, Tong and allies are attempting to make mifepristone as accessible as any other prescription drug within their jurisdictions, pushing back against national restrictions that indirectly aid anti-abortion states.

The petition also rebuts opposition from groups like the Charlotte Lozier Institute and the Ethics and Public Policy Center, which submitted flawed or retracted studies claiming higher complication rates. The states argue these organizations are ideologically motivated and their studies lack credibility, pointing instead to peer-reviewed data and decades of real-world outcomes.

Why This Matters:
If successful, this could permanently shift the regulatory landscape for abortion pills. Eliminating REMS would not only reduce barriers for patients but also insulate access in protective states against shifting federal politics. On the other hand, refusal by the FDA could lead to another round of lawsuits—potentially pushing the issue toward the Supreme Court, which is already primed to revisit FDA v. Alliance for Hippocratic Medicine.

In short: Tong and his coalition are not just asking for access—they’re making a legal, scientific, and federalist argument that REMS are no longer legally defensible. It’s a strategic move to harden abortion access at the state level while forcing the FDA to justify a 25-year-old regulatory scheme in light of overwhelming safety evidence.

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