Citizen Petition from American College of Obstetricians and Gynecologists

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.

The UCLA Law Center for Reproductive Health, Law, and Policy and UCSF Advancing New Standards in Reproductive Health, representing 263 reproductive health researchers, submit this comment in support of citizen petitions asking the FDA to refrain from imposing additional restrictions on mifepristone. They argue that decades of gold-standard science confirm the safety and effectiveness of mifepristone, including via telehealth, and contend that recent reports suggesting risks are methodologically flawed and lack transparency.

Stephen Ghostley 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.

Michael Reilly 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.

Harold Goodman 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.

An individual 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 and robust safety measures.

Br. Mark Gehret 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 and robust safety measures.

A physician who has delivered over a thousand babies supports the petition's goal of restricting the medication to prescription-only status. They argue that the medication should only be prescribed by physicians with specific hospital privileges to manage potential complications.

A board-certified OB/GYN and member of ACOG opposes the citizen petition. The commenter argues that the current unsupervised use of mifepristone is a political rather than scientific decision and urges the FDA to reinstate pre-2016 REMS requirements.

Arkansas Right To Life, an advocacy organization, opposes the citizen petition by the American College of Obstetricians and Gynecologists. They argue that the FDA should maintain strict Risk Evaluation and Mitigation Strategies (REMS) for mifepristone, including in-person physician visits and ultrasound requirements, to ensure safety and prevent unauthorized use.