Report Calls for Sweeping Changes At the FDA

In September, the Institute of Medicine of the National Academy of Sciences, a congressionally created entity dedicated to the study of policy matters pertaining to the public health, issued the results of the study of federal drug safety policy commissioned by the Food and Drug Administration (FDA). The resulting report, titled 'The Future of Drug Safety, Promoting and Protecting the Health of the Public' and published in the Archives of Internal Medicine, has been widely anticipated in light of recent publicity surrounding Vioxx' and other drugs that, subsequent to FDA-approval, proved more dangerous than thought. The authors' goals in carrying out the study included gaining a better understanding of the FDA's current role and the roles of other actors in the process and assessing how changes in these organizations and systems could help promote increased drug safety and better public confidence. The committee's bottom line assessment was that major changes in the way the FDA is organized and funded are needed.