Citizen Petition from Attorney General of Massachusetts, et al.

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.

Paul F. Jarosinski, a pharmacist, opposes the proposed action by arguing that mifepristone should not be available via mail order. He contends that the medication requires direct physician supervision and physical exams to ensure patient safety and to prevent misuse.

Heartbeat International, Inc., a nonprofit organization providing pregnancy resources, opposes the petition from the Massachusetts Attorney General and other states to maintain relaxed regulations on mifepristone. The organization argues that the FDA should instead strengthen the Risk Evaluation and Mitigation Strategy (REMS) by reinstating in-person dispensing, mandatory adverse event reporting, and ultrasound requirements to ensure patient safety and informed consent.

A family physician shares personal clinical experiences regarding the risks and complications associated with the unsupervised use of mifepristone. The commenter argues that the medication requires stricter medical oversight and support to prevent physical and emotional trauma for patients.

A practicing family medicine and obstetrics physician from rural Kansas argues that the risks of Mifepristone may be higher than currently reported. The commenter supports maintaining REMS safeguards until more comprehensive data on serious side effects is available to ensure patient safety.

A certified Acute Care Nurse Practitioner opposes the proposed action to loosen restrictions on mifepristone and misoprostol. The commenter argues that mail-order dispensing lacks adequate supervision and calls for reinstated REMS, mandatory ultrasounds, and stricter reporting of adverse events to ensure patient safety.

The commenter argues that the FDA should not expand access to mifepristone due to concerns regarding serious adverse events identified in a report by the Ethics and Public Policy Center. They advocate for the reinstatement of stricter regulations, including mandatory healthcare professional consultations and limits on prescription duration.

The Attorney General of Massachusetts is urging the FDA to reexamine its approval of mifepristone for medication abortions. They argue that the medication is associated with serious adverse events and call for a comprehensive review of clinical data to ensure public safety and informed consent.