Monday, October 30, 2006

Capitol Hill Watch

Congress Likely To Consider FDA Postmarket Prescription Drug Safety Surveillance in 2007

      FDA's tracking system for reporting adverse side effects of approved prescription medications is likely to be among a series of safety issues considered by Congress in 2007, when FDA reform legislation will be on the agenda, the Newark Star-Ledger reports (Cohen, Newark Star-Ledger, 10/30). A Government Accountability Office report released in April found that FDA "lacks a clear and effective process" for tracking safety issues related to approved drugs (Kaiser Daily Health Policy Report, 4/24). A group of physicians in a recent Archives of Internal Medicine article came to similar conclusions, while an Institute of Medicine report released in September reported similar findings and made recommendations for improvement. Under the current system, drug makers are required to report serious adverse events to FDA within 15 days of discovery. In addition, manufacturers must report other problems quarterly for the first three years upon market arrival and annually thereafter. Hospitals, physicians and individuals also can submit reports. Curt Furberg, a member of the FDA's drug safety and risk management advisory committee, estimates that reported events represent only about 10% of the serious side effects that occur annually and only about 1% of total side effects. Arthur Levin, director of the Center for Medical Consumers and the consumer representative on the FDA's drug safety advisory committee, said FDA's reporting system "wait[s] for problems to come in as data, not looking proactively, and there is vast underreporting, which everyone acknowledges." He added that FDA needs "real-time monitoring of large populations that are real users of drugs" (Newark Star-Ledger, 10/30).