Contraception Special Issue on the Mifepristone Risk Evaluation and Mitigation Strategy (REMS)

Contraception; 2021 July 1; Vol. 104(1):1-3; doi:https://doi.org/10.1016/j.contraception.2021.05.012
Kelly Cleland, Angel Foster, Anu Gomez, and Beth Raymond were Guest Editors for this Special Issue

Editorial: The safety and efficacy of mifepristone for medication abortion have been well-established during more than 20 years of use in the United States (US). Yet, in the US, the Food and Drug Administration (FDA) regulates mifepristone by a Risk Evaluation and Mitigation Strategy (REMS) and associated Elements to Assure Safe Use (ETASU). These regulations place constraints on where, and by whom, mifepristone may be dispensed. Mifepristone must be dispensed directly from healthcare facilities, not retail pharmacies; providers must register as certified prescribers, and patients must sign an agreement that is separate from standard informed consent. A growing body of evidence demonstrates that the existing restrictions are unnecessary and overly burdensome, yet these regulations remain.

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