Citizen Petition from GenBioPro, Inc.

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 hinder patient access and the provider-patient relationship.

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 restrict access based on "junk science" and misleading narratives that conflate routine care-seeking with serious medical complications.

Abortion On Demand (AOD), a physician-owned LLC providing telehealth medication abortion, supports the citizen petitions to eliminate FDA restrictions on mifepristone access. The commenter argues that their telehealth model provides safe, convenient, and timely care, particularly for rural patients and those facing barriers like transportation or childcare.

The Boston University School of Law, representing several of its programs, supports the citizen petitions seeking to eliminate or limit restrictions on mifepristone. They argue that current REMS requirements and potential new restrictions create undue burdens on marginalized communities, particularly those of color, low-income individuals, and those in medically underserved areas.

Hey Jane, a telehealth reproductive healthcare provider, submits this comment in support of the citizen petitions. The company argues that mifepristone access via telehealth is safe, effective, and vital for patient access, citing numerous positive patient experiences and clinical data.

The Catholic Medical Association (CMA), an organization of Catholic physicians and healthcare professionals, opposes the proposed reduction of mifepristone regulations. They argue that the petition relies on biased data that underestimates serious adverse effects and that the proposed changes would exacerbate ethical and safety concerns regarding telemedicine chemical abortions.

The Catholic Medical Association (CMA) opposes the petition to reduce or eliminate FDA safety regulations (REMS and EASU) for mifepristone. They argue that the petition relies on biased data that underestimates serious adverse effects and that removing safeguards would exacerbate ethical and societal risks associated with telemedicine chemical abortions.