Comment from J S
AnonymousOpposeOther
Summary: 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 FDA cannot expand risks to women's health by liberating access to this medication with our greater knowledge from the Ethics and Public Policy Center (EPPC) report. The EPPC report from April 2025 is one of the largest studies of mifepristone to date, including nearly one million individuals over about 7 years of time. Significantly more women suffered serious adverse events than would have been expected based on FDA claims -- 22 times more than expected. This report sheds light on a nonnegotiable necessity to take greater caution, not less, with mifepristone! The FDA should reinstate stricter regulations on mifepristone use, such as but not including consultation with healthcare professionals before receiving any prescriptions, limits on duration of prescription use, and monitoring. The FDA should also be pressed to require that all adverse events are reported, and that continued evaluation of adverse effects are conducted.