The U.S. Food and Drug Administration is required to approve all drugs and devices before they enter the market. In recent years the Vioxx episode and other drug controversies have heightened the public's perception that the FDA's approval process has become too quick and careless. But in fact, Sam Kazman argues, the opposite is more likely—that the FDA suffers from "deadly overcaution". In its quest to reduce the risk of unexpected side effects from new therapies, the agency is overlooking the fact that delaying the introduction of new drugs may pose the greatest health risk of all.
Sam Kazman is general counsel of the Competitive Enterprise Institute in Washington, D.C., where he is involved in public interest litigation and policy analysis.