Citizen Petition from GenBioPro, Inc.

The Boston University School of Law's various legal programs submit a supplemental comment supporting the removal of the Mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS). They argue that restricting access to mifepristone increases intimate partner violence (IPV) and imposes significant social and economic costs, particularly on marginalized and low-income communities.

Heartbeat International, Inc., a nonprofit organization providing pregnancy resources, opposes GenBioPro, Inc.'s petition to maintain relaxed regulations on mifepristone. They argue that the FDA should instead strengthen the Risk Evaluation and Mitigation Strategy (REMS) by reinstating in-person dispensing, mandatory adverse event reporting, and ultrasound requirements to ensure patient safety and informed consent.

A board-certified family medicine physician argues that the proposed action is necessary to ensure women receive face-to-face medical care and proper oversight for pregnancy-related issues. The commenter emphasizes the risks of surreptitious medication and advocates for regulations that prioritize high standards of medical care and physician intervention.