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Viewpoint |

New Opportunities for Integrating Drug Safety Risk Management Programs Into the Health Care System Bridging the Divide

Meredith Y. Smith, PhD, MPA1; Paul J. Seligman, MD, MPH1
[+] Author Affiliations
1Amgen Inc, Thousand Oaks, California
JAMA. 2015;314(17):1793-1794. doi:10.1001/jama.2015.11871.
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This Viewpoint discusses the role of the FDA’s Risk Evaluation and Mitigation Strategies program in monitoring drug safety and proposes ways the program can be redesigned for better integration into the US health care system.

Effectively managing the risks of medical products is an essential attribute in the delivery of high-quality clinical care. Approximately 1 decade ago, the US Food and Drug Administration (FDA) developed a new approach to monitoring drug safety: postmarketing risk management programs known as Risk Evaluation and Mitigation Strategies (REMS).1 Although the FDA’s use of this approach has increased over time, the benefit of these programs remains unclear: few REMS programs have undergone rigorous evaluation and, for those that have, results have frequently been either inconclusive or shown limited effectiveness.2 “Risk minimization” programs come with a price tag as well: although drug company sponsors bear the direct costs of designing, implementing, and evaluating them, the health care system incurs significant indirect costs associated with REMS programs. A critical question concerns how to bridge the divide between the health services delivery system, which is undergoing transformation into a “continuous learning system,” and REMS programs as currently configured.3

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