Comment from Leslie Harmon

AnonymousOpposeIndividual
Summary: Leslie Harmon opposes the proposed action to weaken safety protocols and remove Risk Evaluation and Mitigation Strategy (REMs) requirements for mifepristone. The commenter argues that the drug poses significant risks to women's health and should be subject to strict regulation and robust safety measures.
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. FDA data links this drug to at least 36 deaths and thousands of adverse events. A 2024 Ethics and Public Policy Center report found that 11% of chemical abortions resulted in adverse events. 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. Urgently, Leslie Harmon

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