Use of risk evaluation and mitigation strategies by the US Food and Drug Administration, 2008-2019


21 July 2020 - The US FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and Mitigation Strategy to “ensure the benefits of the medication outweigh its risks.”

At its inception, the Risk Evaluation and Mitigation Strategy 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” such as prescriber training, prescriber/dispenser certifications, or patient registries.

Despite several important changes to the Risk Evaluation and Mitigation Strategy program, including the 2011 decision to release (or remove) all medications that required a medication guide alone from the program, few comprehensive characterisations of the program have been performed.

Read JAMA article

Michael Wonder

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Michael Wonder