Citizen Petition from GenBioPro, Inc.

FemInEM, a non-profit organization focused on reproductive healthcare in emergency departments, supports the petition to remove the Mifepristone Shared System REMS. They argue that mifepristone is safe and effective, and that emergency department visits following its use are often due to systemic healthcare barriers rather than medication safety concerns.

Advancing New Standards in Reproductive Health (ANSIRH), a research program based at UCSF, supports the citizen petitions to remove the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. They argue that extensive research demonstrates medication abortion is safe and effective, and that current REMS requirements unnecessarily restrict access to care.

Adele Kootz expresses strong opposition to the proposed action, arguing that the FDA should maintain and strengthen safety protocols for mifepristone. She cites concerns regarding PTSD, potential for non-consensual use, and reports of adverse events and deaths associated with the drug.

The Catholic Medical Association (CMA) opposes the petition to reduce or eliminate FDA safety regulations (REMS and EASU) for mifepristone. They argue that the petition relies on biased data that underestimates serious adverse effects and that removing safeguards would exacerbate ethical and societal risks associated with telemedicine chemical abortions.

Erin Witte opposes the proposed action to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. The commenter argues that the drug poses significant health risks and should be subject to strict regulation to protect women's lives.

Mr. Daniel D. Reynolds, a private citizen, opposes the FDA's proposal to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. He argues that the drug poses significant risks to women's health and cites data regarding adverse events and deaths to advocate for maintaining and strengthening current safety regulations.

The commenter opposes the FDA's proposal to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. They argue that the drug poses significant risks to women's health and should be subject to strict regulation based on reported adverse events and deaths.

Leslie Harmon opposes the proposed action to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. The commenter argues that the drug poses significant risks to women's health and should be subject to strict regulation and robust safety measures.

William Burt, an individual with a Master of Science degree, opposes the FDA's proposal to weaken safety protocols and remove REMs requirements for mifepristone. He argues that the drug poses significant risks to women's health and should be subject to strict regulation based on reported adverse events and deaths.

Randel Erickson opposes the FDA's proposal to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. He argues that the drug poses significant risks to women's health and should be subject to strict regulation based on reported adverse events and deaths.