Public Comment: PRH Supports Removing Unnecessary FDA Restrictions on Mifepristone
PRH calls on the FDA to remove harmful REMS restrictions on mifepristone and protect medication abortion access.
WHY THIS MATTERS
PRH responded to four citizen petitions requesting FDA remove burdensome restrictions on mifepristone. Our response supports the call on the FDA to eliminate the current restrictions on access to mifepristone under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program or at a minimum refrain from taking any action that would further increase barriers to access.
This comment offers excerpts from physician stories that describe their experiences providing medication abortion care and the importance of access to mifepristone.
WHAT YOU NEED TO KNOW
- Mifepristone is backed by decades of evidence. More than 20 years of research and over 100 peer-reviewed studies confirm its safety and efficacy.
- Medication abortion is common and safe. In 2023, it accounted for 63% of abortions in states without total bans, with extremely low complication rates.
- Telehealth is safe and effective. Physicians report that telehealth medication abortion includes follow-up care and standardized screening, with outcomes comparable to in-person visits.
- Mifepristone is essential beyond abortion. It improves outcomes in miscarriage management and pregnancy loss by increasing effectiveness and reducing complications.
- Restrictions undermine patient trust and autonomy. When physicians are forced to withhold safe, evidence-based options, the patient-provider relationship suffers and public health is harmed.