Perspective - Risks and benefits of risk-management plans

Scott Gottlieb criticizes the emphasis on the greater use of risk-management plans in the recent Institute of Medicine (IOM) report on drug safety and the Kennedy-Enzi bill as impractical, failing to recognize the underlying causes of recent drug risk concerns, having the potential to create barriers to care, and interfering unnecessarily in physician decision making. These are worthy concerns but ones that need to be considered in the context of specific regulatory decisions for individual drugs. This is precisely the motivation for calls for greater attention to the potential use of risk-management plans in drug evaluation.