Expert Workshop: Strengthening Risk Evaluation and Mitigation Strategies (REMS) Through Systematic Analysis, Standardized Design, and Evidence-Based Assessment

On Wednesday, September 25, 2013, the Engelberg Center for Health Care Reform at Brookings convened a diverse group of regulated industry, regulators, content area experts, health care providers, and other key stakeholders to explore systems-based approaches to standardizing REMS design, standardized frameworks for REMS tool development and selection, and strategies to assess the effectiveness of REMS. Following the passage of the Food and Drug Administration Amendments Act of 2007, the U.S. Food and Drug Administration (FDA) was authorized to require Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug outweigh its risks. Since the development of the REMS program, concerns have arisen regarding the impact on patient access and undue burden on the health care system. In response, FDA has sought stakeholder feedback and launched initiatives to improve the standardization, assessment, and integration of REMS within the existing and evolving health care system. This workshop presented an opportunity to augment these ongoing efforts by moving towards the adoption of systematic methods to increase the effectiveness of REMS programs and reducing much of the uncertainty and burden on the health care system.