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November 3, 2015

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

Author Affiliations
  • 1Amgen Inc, Thousand Oaks, California
JAMA. 2015;314(17):1793-1794. doi:10.1001/jama.2015.11871

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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