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.

Jamie Phifer, M.D., representing Abortion On Demand (AOD), a physician-owned LLC, supports the citizen petitions requesting the FDA eliminate restrictions on mifepristone access. The commenter argues that AOD's telehealth model provides safe, convenient, and timely medication abortion care, particularly for rural and low-income patients who face significant barriers to in-person care.

Hey Jane, a telehealth reproductive healthcare provider, submits this comment in support of the citizen petitions to eliminate restrictions on mifepristone access. The company argues that telehealth medication abortion is safe, effective, and provides vital, convenient, and private access to care for patients across the country.

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.

The Family Research Council, a nonprofit research and educational organization, opposes the American College of Obstetricians and Gynecologists' request to remove or reduce the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. They argue that the drug is unsafe, citing risks of sepsis and hemorrhage, and urge the FDA to instead strengthen safety protocols, including requirements for ultrasounds and blood testing.

Legal Voice, Family Violence Appellate Project, Sexual Violence Law Center, and the Washington State Coalition Against Domestic Violence submit a joint comment in support of a petition to remove the Mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS). They argue that maintaining easy access to mifepristone, particularly through telehealth and mail delivery, is critical for the safety and reproductive autonomy of survivors of intimate partner violence (IPV) and marginalized communities.