Risk Evaluation and Mitigation Strategies (REMS) are programs designed to ensure that certain drugs and biologics with serious risks are used safely. The U.S. Food and Drug Administration (FDA) requires a drug's sponsor to establish a REMS when the Agency is concerned that the risks of a biomedical product might otherwise outweigh its benefits. Since the inception of REMS in 2008, stakeholders have raised concerns over REMS' burden on providers and the healthcare system more broadly, as well as the potential barriers it might create for patient access to REMS products.
In an effort to address these concerns, FDA has pursued a number of initatives aimed at improving the design, operation, and assessment of REMS programs.
In support of these efforts, and under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy held an expert workshop on April 14th, 2016 titled, “Risk Evaluation and Mitigation Strategies: Improving Benefit-Risk Counseling Between Providers and Patients.” This workshop provided an opportunity for stakeholders across academia, industry, health systems, and patient advocacy groups, among others, to provide input on a draft concept paper and framework of desired outcomes, guiding principles, and best practices for benefit-risk counseling for medications with a REMS. A draft framework for the concept paper was initially presented to a small group of external stakeholders at an earlier workshop in July 2015, hosted by the Brookings Institution (see the meeting summary here), and was subsequently revised based upon the initial feedback from this group. he April workshop provided an opportunity for a broader range of stakeholders with extensive knowledge of and experience with effective patient counseling methods to provide additional input into the revised concept paper and guidance as to its further development.
Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.