According to the Institute of Medicine (IOM) Committee on the Assessment of the U.S. Drug Safety System, "The recent highly publicized controversies surrounding the safety of some drugs have contributed to a public perception that the drug safety system is in crisis. It seems fair to say that this perception has created an opportunity for a thorough evaluation of the U.S. drug safety system." The evaluation was focused on the U.S. Food and Drug Administration (FDA). To improve the FDA and its function in the public health system to improve therapeutics, it is critical to understand the contributions of other components.