FDA Responds to Institute of Medicine Drug Safety Recommendations—In Part

THE WITHDRAWAL OF ROFECOXIB IN SEPTEMBER 2004 and the reports of health risks associated with several other drugs have raised questions about the integrity of the US drug safety system. In response, and at the request of the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) issued a comprehensive review and set of recommendations for reforms. The FDA has taken the unusual step of providing a detailed, public response. The FDA’s new initiatives and its responsiveness to the IOM report represent incremental progress that offers insights into FDA’s culture and perhaps glimpses at the future of drug safety.