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Research Letter
July 21, 2020

Use of Risk Evaluation and Mitigation Strategies by the US Food and Drug Administration, 2008-2019

Author Affiliations
  • 1Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago College of Pharmacy
  • 2Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA. 2020;324(3):299-301. doi:10.1001/jama.2020.6611

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.