Comment from The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG)
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Summary: The American College of Obstetricians and Gynecologists (ACOG) is submitting a citizen petition requesting that the FDA restore and strengthen the original 2000 Mifeprex regimen and Risk Evaluation and Mitigation Strategy (REMS). They argue that the 2016 changes—which expanded the gestational limit, allowed for home administration, and reduced required in-person visits—compromise patient safety by increasing the risk of complications, infections, and failures.
Please see attached files in response to FDA-2025-P-0377-0001. The first attachment is a re-submission of a 2019 citizens petition filed in response to the FDA's changes to mifepristone in 2016, to which our concerns remain the same. The second attachment is a letter highlighting our concerns with additional changes made since that time, including removal of the in-person dispensing requirement.