Comment from Daniel D. Reynolds
AnonymousOpposeIndividual
Summary: Mr. Daniel D. Reynolds, a private citizen, opposes the FDA's proposal to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. He argues that the drug poses significant risks to women's health and cites data regarding adverse events and deaths to advocate for maintaining and strengthening current safety regulations.
To whom it may concern,
I am strongly opposed to the FDA weakening safety protocols and removing the Risk Evaluation and Mitigation Strategy (REMs) safety requirements for the abortion drug mifepristone. Drugs with significant risks must be strictly regulated, and mifepristone is no exception. The FDA’s adverse event data through December 2024 reports 36 deaths associated with mifepristone along with thousands of adverse events. The 2024 Ethics and Public Policy Center (EPPC) report estimates an 11% serious adverse event rate, including ectopic pregnancies and hemorrhage, significantly higher than the FDA’s 0.5%. When a drug poses such dangers to women’s health and lives, robust safety measures are essential. I urge the FDA to maintain—and strengthen—current safety protocols for mifepristone to protect women nationwide.
Signed,
Mr. Daniel D. Reynolds
Worcester, MA 01604