title: Risks and benefits of risk-management plans.
abstract: 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.
authors.affiliation: Department of Medicine, University of Chicago, USA. d-meltzer@uchicago.edu
authors.forename: David
authors.initials: D
authors.lastname: Meltzer
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D010818:Practice Patterns, Physicians'; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management / Q000379:methods*; D014481:United States