Citizen Petition from GenBioPro, Inc.

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 the medication remains accessible without age-based restrictions or regulations.

The Disability Rights Education and Defense Fund (DREDF) supports the petition to prevent the FDA from reinstating in-person dispensing requirements for mifepristone. They argue that such requirements create illegal structural barriers for people with disabilities, who rely on telemedicine and mail delivery to overcome physical, transportation, and financial obstacles to healthcare.

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 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 costs, particularly on marginalized and low-income communities.

GenBioPro, Inc., a generic manufacturer of mifepristone, supports the current safety and efficacy profile of the medication and opposes the imposition of additional restrictions. The company argues that the FDA's review should be based on robust, peer-reviewed scientific evidence rather than flawed, non-transparent third-party reports.

Legal Voice, Family Violence Appellate Project, Sexual Violence Law Center, and the Washington State Coalition Against Domestic Violence are submitting a joint comment in support of the petition. They argue that the FDA should not restrict access to mifepristone, as medication abortion is a vital and safe option for survivors of intimate partner violence who face significant barriers to in-person care.

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 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.

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 review process should be grounded in scientific rigor rather than partisan politics.