A coalition of state attorneys general, including New York's Letitia James, has petitioned the FDA to lift outdated restrictions on mifepristone, an abortion medication deemed safe and effective since its approval 25 years ago. The current Risk Evaluation and Mitigation Strategy (REMS) program imposes excessive requirements that they argue do not enhance patient safety. Citing its inclusion on the WHO's essential medicines list, the coalition asserts that these restrictions should be reconsidered during the FDA's ongoing review of mifepristone's labeling requirements.
The petition argues that mifepristone has proven overwhelmingly safe and effective, making current REMS restrictions unnecessary and burdensome for patients seeking access to the medication.
By including mifepristone in the WHO's list of essential medicines, advocates are highlighting the drug's safety record and the imperative to remove outdated access restrictions.
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