Comment from Jean Parker
AnonymousOpposeIndividual
Summary: The commenter opposes the citizen petition to remove the Mifepristone REMS Program, arguing that the petition misrepresents the drug's safety and ignores medical and ethical risks. They urge the FDA to reinstate stricter requirements, such as mandatory ultrasound exams and in-person physician visits, citing discrepancies in reported adverse effect data.
I strongly oppose the above Citizen Petition requesting the removal and/or non-enforcement of the Mifepristone REMS Program, as it misrepresents mifepristone’s safety and ignores significant medical, ethical, and societal risks, particularly with telemedicine chemical abortion.
In fact, I adjure the FDA to reinstate the previous REMS requirements, including the required reporting of serious adverse effects from mifepristone, an ultrasound to determine gestational age and rule out ectopic pregnancy, in person physician visits, reduced gestational age of use, and reporting of all serious adverse effects, not just maternal death as the current REMS require.
Recent real-world data on serious adverse effects of mifepristone from European studies and the recent American EPPC report, indicate a considerable discrepancy from the rates traditionally reported by the FDA and mifepristone drug manufacturers. This discrepancy must be resolved by the FDA, if it is serious about women’s health and informed consent protections, as I believe it is.