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.

Physicians for Human Rights (PHR) supports the citizen petitions requesting that the FDA refrain from imposing additional restrictions on mifepristone. They argue that the drug is safe and effective based on extensive clinical evidence and that the review process should be grounded in scientific rigor rather than partisan politics.

Ohio Right to Life, an advocacy organization, opposes the proposed action because it would prevent the FDA from restricting access to or increasing regulations on mifepristone. The organization argues that the drug is unsafe, citing high rates of serious adverse events and deaths, and calls for a reconsideration of the research data supporting its use.

A physician with over 34 years of experience opposes the petition, arguing that Mifepristone lacks sufficient safety regulations. The commenter expresses concern over potential side effects and emphasizes the need for rigorous evaluation of medications to ensure patient safety.

The commenter opposes the citizen petition to remove the Mifepristone REMS Program, arguing that the petition misrepresents the drug's safety and ignores medical and ethical risks. They urge the FDA to reinstate stricter requirements, such as mandatory ultrasound exams and in-person physician visits, citing discrepancies in reported adverse effect data.

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.

William J. Hickey 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 health risks and should be subject to strict regulation to protect women.

Robert Smith opposes the proposed action 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 and robust safety measures.