Citizen Petition from Attorney General of Massachusetts, et al.

Physicians for Reproductive Health, a physician-led national advocacy organization, supports the citizen petitions requesting the FDA eliminate 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, through several of its legal programs, submits 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.

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.

The Boston University School of Law, representing several of its programs, supports the citizen petitions seeking to eliminate the Mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS) or, at minimum, prevent any additional restrictions on the medication. They argue that current REMS requirements create undue burdens and exacerbate racial, economic, and geographic inequities in reproductive healthcare access.

Jamie Phifer, M.D., representing Abortion On Demand (AOD), supports the citizen petitions requesting that the FDA eliminate restrictions on mifepristone access under the Single Shared System REMS Program. The commenter argues that AOD's telehealth model provides safe, convenient, and timely medication abortion care, particularly for rural and low-income patients who face significant barriers to in-person care.

The Boston University School of Law, representing several of its programs, supports the citizen petitions seeking to eliminate the Mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS) or, at minimum, prevent any additional restrictions on the medication. They argue that current REMS requirements create undue burdens and exacerbate racial, economic, and geographic inequities in reproductive healthcare access.

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 patients, and they urge the FDA to eliminate current restrictions on its access.

The Reproductive Health Outcomes and Disparities (RHOADs) Research Lab at the University of Chicago submitted this comment in support of the citizen petitions. They argue that the FDA should remove the mifepristone REMS or refrain from further restricting access, citing research that shows such regulations create significant barriers to care and lead to adverse maternal, infant, and socio-economic outcomes.