Managing the risks of therapeutic products: proceedings of a workshop.

Traditional tools available to the Food and Drug Administration for managing known risks of therapeutic products (drugs, devices and biological products) have limited effectiveness. This report presents the recommendations of a multidisciplinary workshop focused on managing these risks. This is the last in a series of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) on assessing, communicating and managing the risks and benefits of therapeutic products. Workshop participants included experts from government, academia, industry and healthcare organizations, including consumers. Using a modified nominal group process, participants developed a consensus on principles that should govern future risk management (RM) programs, specifically: in order to protect the public health, risk management programs (RMPs) should be evidence-based, science-driven and patient-focused. A plan to manage the risks of each new therapeutic product should be developed prior to its approval. Evaluation of both the processes and outcomes of RM is essential; these evaluations should be in the public domain. Participants also identified and prioritized research and policy gaps related to RM. Recommended research areas included determining the effectiveness of each element of RMPs, finding the best ways to inform healthcare consumers and determining the best way to present risk information in drug labeling. Policy questions included defining the criteria for requiring a RMP, determining the effect of privacy legislation on RMPs and determining how the continuum of risk across therapeutic products should be classified. As this workshop demonstrated, it is possible to develop a prioritized research and policy agenda to meet the needs of all constituencies. Collaboration across diverse government, academic, industry and constituency-based organizations can lead to solutions for the perplexing problems involved in balancing the risks and benefits of therapeutic products. Patients deserve no less as we strive to protect their safety.

Duke Scholars

Author Judith Mae Kramer Medicine, General Internal Medicine