In the wake of the recent spate of drug withdrawals and other drug safety issues, there have been renewed calls to reform and enhance the U.S. approach to monitoring safety issues in marketed products. These calls have come from many quarters, and a variety of initiatives have been the result.

Until very recently, drug side effects monitoring for marketed products has rested largely in the hands of drug companies. They are required to keep tabs on emerging safety issues and alert the FDA of their findings on a regular basis. While they are legally required to report safety issues of which they become aware, the same is not true of the other players in the system, namely healthcare providers and patients. There are mechanisms for capturing events that these individuals care to report, but it is a voluntary, and therefore incomplete, approach.