Citizen Petition from Attorney General of Massachusetts, et al.

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 for non-urgent reasons or due to systemic healthcare barriers rather than drug safety issues.

A group of adolescent health researchers and clinicians argue that mifepristone is safe and effective for use by minors, citing clinical data and pharmacological evidence. They urge the FDA to ensure continued access to the medication without age-based restrictions, specifically refuting claims that it poses risks to the developing bodies of adolescents.

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, and they criticize recent efforts to use "junk science" and misleading narratives to restrict access to medication abortion.

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 current review is based on flawed, non-transparent research.

The Catholic Medical Association (CMA) opposes the proposed changes to mifepristone regulations, arguing that the petition relies on biased data and fails to account for the serious physical, psychological, and ethical risks of chemical abortion. They advocate for strengthening current safety safeguards, including mandatory in-person consultations and more comprehensive informed consent requirements.

Advancing New Standards in Reproductive Health (ANSIRH), a research program based at UCSF, supports the citizen petitions to remove the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. They argue that extensive research demonstrates medication abortion is safe and effective, and that current REMS requirements unnecessarily restrict access to care without improving safety outcomes.

The commenter, representing an advocacy group, 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 safety protocols, mandate full side-effect reporting, and reconsider the drug's approval entirely.

The commenter, representing an advocacy group, 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 safety protocols, mandate full side-effect reporting, and reconsider the drug's approval entirely.

The commenter argues that the petition is "spurious" and claims that the data regarding mifepristone's adverse events is being ignored. They advocate for greater controls on the medication.

Melinda Wade opposes the FDA's proposal to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. She argues that the drug poses significant risks to women's health and should be subject to strict regulation and robust safety measures.