CLI Submits Comment Responding to Washington et al.’s Citizen Petition Requesting FDA Action on Mifepristone

In October 2025, CLI submitted a comment responding to Washington Attorney General Nicholas Brown’s citizen petition submitted to the FDA, joined by the AGs of 16 other states and D.C., requesting regulatory action on the abortion drug mifepristone. This came as part of a multi-state effort led by the AGs of Massachusetts, California, New York, and New Jersey initiated in June 2025 to petition the FDA to remove crucial safety regulations on the drug. (CLI’s response to this earlier petition and two related petitions can be found here.)

In their petition, Washington et al. joined the previous petitioners in calling for the FDA to “remove the Mifepristone REMS [Risk Evaluation and Mitigation Strategy] Program in its entirety.” The REMS for a medication are, according to the FDA, “designed to reinforce medication use behaviors and actions that support the safe use” of medications considered to have serious safety concerns. They are further intended to “focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.” Washington et al. supported Massachusetts et al. in arguing that mifepristone does not need any REMS because there are no serious risks of the drug, and that it is safe and effective. They went on to additionally attack CLI’s credibility and arguments made by CLI in its comment responding to the original petition, as well as appealing to their own state-level data to justify the claim that mifepristone needs no REMS.

In this most recent comment, CLI responds by arguing, among other points, that petitioners cite unreliable state data regarding mifepristone-related complications, that CLI’s research is credible and recent retractions were ideologically motivated, that petitioners prematurely dismissed studies showing increases in pregnancy-associated mortality following abortion, and that they improperly disregard concerns regarding mifepristone contraindications and the possibility of coercion.

The full text of CLI’s comment can be found here.

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