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.

A group of adolescent health researchers and clinicians argue that mifepristone is safe and effective for use by minors, citing clinical evidence and pharmacological data. They urge the FDA to ensure continued access to the medication without age-based restrictions or regulations.

The Disability Rights Education and Defense Fund (DREDF) supports the petition to remove the mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS) and its in-person dispensing requirement. They argue that reinstating such requirements would create illegal structural barriers to healthcare for people with disabilities, violating federal disability rights laws and the Food and Drug Administration Amendments Act.

Physicians for Reproductive Health, a physician-led national advocacy organization, supports the citizen petitions requesting the removal of restrictions on mifepristone access. They argue that mifepristone is safe and effective for medication abortion and miscarriage management, and that current restrictions—particularly those requiring in-person dispensing—unnecessarily create barriers to care and harm the patient-provider relationship.

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 burdens, particularly on marginalized and low-income communities.

RHITES (Reproductive Health Initiative for Telehealth Equity & Solutions) supports the citizen petitions requesting that the FDA eliminate restrictions on mifepristone access under the Single Shared System REMS Program. They argue that telehealth for medication abortion is safe, effective, and provides critical benefits by reducing travel burdens, costs, and stigma for patients.

The National Abortion Federation and Planned Parenthood Federation of America are submitting a joint comment in support of a citizen petition by the American College of Obstetricians and Gynecologists. They advocate for the FDA to remove the Mifepristone Shared System REMS Program or, at minimum, refrain from imposing additional burdens on patient access to the medication.

The American College of Obstetricians and Gynecologists, the Society of Family Planning, and the Society for Maternal-Fetal Medicine are submitting a supplemental petition requesting that the FDA remove the Mifepristone Shared System REMS Program and refrain from imposing further burdens on patient access. They argue that mifepristone has a well-established safety and efficacy profile based on decades of research and that current restrictions are based on "junk science" and "baseless claims" from opponents.

The Guttmacher Institute, a research and policy organization, submits this comment in support of citizen petitions regarding the FDA's regulation of mifepristone. They argue that mifepristone is safe and effective, citing extensive scientific consensus and global usage, while criticizing anti-abortion narratives that mischaracterize routine patient care as serious medical complications.

Physicians for Human Rights is submitting this comment in support of 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 current review is based on flawed, non-transparent research.