Comment from FemInEM

FemInEM is a non-profit organization dedicated to the improvement of reproductive healthcare delivered in emergency departments across the country. FemInEM's mission is to address disparities in outcomes for patients by equipping medical professionals with the tools, knowledge, and resources they need to deliver effective and time-sensitive care. FemInEM respectfully urges FDA to (1) remove the Mifepristone Shared System REMS, including all of its ETASU; or (2) in the alternative, at a minimum, refrain from taking any action that would further reduce patient access to mifepristone and/or increase the burdens associated with prescribing or dispensing mifepristone. The scientific and medical evidence overwhelmingly demonstrates that mifepristone is safe and effective, including when prescribed via telehealth and dispensed through pharmacies and by mail. Emergency department visit data does not support any characterization of mifepristone as unsafe; rather, it reflects the reality that Americans use emergency departments for a wide array of non-urgent healthcare needs due to systemic barriers to accessing other care. Maintaining or increasing restrictions on mifepristone will deny patients safe methods of accessing care and impose far-reaching effects on emergency departments' ability to provide necessary healthcare, particularly in rural and underserved communities. The evidence is clear that mifepristone is safe, effective, and critical to the practice of emergency medicine. Please see attached PDF for full comment.