Abstract
This paper analyzes the influential September 2006 Institute of Medicine (IOM) report entitled The Future of Drug Safety. It also analyzes the US FDA's and the politicians' FDA Amendments Act (FDAAA) response to it from a risk-communication perspective. This article begins with an extensive background discussion as to why the IOM report was commissioned. Then, it outlines and analyzes, from a risk-communication perspective, a number of the IOM's suggested recommendations. In the third section, a number of overarching critiques of the IOM report are provided and, in the final section, a similar analysis is provided for the FDA's and politicians' (FDAAA) responses to the IOM report. Overall, the IOM's report is an intelligent, well-structured document that provides a number of very useful recommendations. That said, the report is comparatively weak with regard to its recommendations associated with risk communication. Medical and drug risk communication is currently in its infancy.