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.

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 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.

The commenter shares a personal narrative about undergoing a medication abortion using mifepristone to preserve her education and career goals. She argues that mifepristone is a safe and essential tool for reproductive freedom, emphasizing that women's autonomy and personal lives are often overlooked in the legislative debate.

An internal medicine doctor from Michigan opposes the ACOG petition to remove Mifepristone from the REMS. The commenter argues that the drug poses significant risks to both mothers and fetuses and advocates for stricter safety requirements, such as in-person prescribing and mandatory diagnostic tests.

The Catholic Medical Association (CMA) opposes the proposed changes to mifepristone regulations, arguing that the petition relies on biased data and threatens women's health. They advocate for strengthening current safety safeguards, including mandatory in-person consultations and more comprehensive informed consent regarding risks and alternatives.

The American College of Obstetricians and Gynecologists argues that the real-world rate of serious adverse events from mifepristone is significantly higher than reported in clinical trials. They urge the FDA to reinstate stricter patient safety protocols, mandate full side-effect reporting, and reconsider the drug's approval based on these safety concerns.

Randall Hall-Laos opposes the FDA's proposal to weaken safety protocols and remove REMS requirements for mifepristone. The commenter argues that the drug poses significant risks to women's health and should be subject to strict regulation.