The US Food and Drug Administration (FDA) Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and Mitigation Strategy (REMS) to “ensure the benefits of the medication outweigh its risks.”1 At its inception, the REMS program could require (1) that pharmacies distribute medication guides; (2) that manufacturers design communication plans about specific safety issues; and/or (3) that manufacturers provide “elements to assure safe use” (ETASUs) such as prescriber training, prescriber/dispenser certifications, or patient registries.1 Despite several important changes to the REMS program, including the 2011 decision to release (or remove) all medications that required a medication guide alone from the program,1 few comprehensive characterizations of the program have been performed.
Guadamuz JS, Qato DM, Alexander GC. Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019. JAMA. 2020;324(3):299–301. doi:10.1001/jama.2020.6611
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