In September 2004, Merck & Co. pulled its widely prescribed arthritis drug Vioxx off the market. The Food and Drug Administration followed with the release of a study that found Vioxx may have led to more than 27,000 incidences of heart attack or sudden cardiac deaths. The FDA based its findings on an analysis of patients’ records in a database created by Kaiser Permanente.
Since then, Congress has been pressuring the FDA to improve and computerize its early-warning drug system. In September 2007, it passed the Prescription Drug User Fee Amendments, which mandated the FDA to set up a computerized drug-safety surveillance system.