The U.S. Food and Drug Administration (FDA) Science Board recently released a report suggesting that the agency’s inability to modernize its IT systems has resulted "in a plethora of inadequacies that threaten our society," Government Executive reports. Though the FDA has yet to publicly release the report, Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions Committee, and Rep. Henry Waxman, (D-Calif.), chair of the House Committee on Oversight and Government Reform, reference the report in a letter sent on Tuesday to Comptroller General David Walker. According to the letter, the Science Board report states that the FDA’s inadequate IT infrastructure has caused "critical capability gaps." The lawmakers also cited findings that suggest the agency lacks necessary information science capabilities and information infrastructure to fulfill its regulatory mandate; cannot provide sufficient infrastructure support to regulate products based on new science; relies on obsolete IT infrastructure that is unstable and lacks necessary controls for ensuring continuity of operations and effective disaster recovery services; and maintains an inadequate IT work force is that is not optimally organized.
Meanwhile, the Government Accountability Office (GAO) on Tuesday released a report that indicates that two FDA databases on foreign medical device manufacturers contained errors and could not automatically exchange data. Kennedy and Waxman have since called on the GAO to conduct a thorough review of FDA's IT infrastructure (Brewin, Government Executive, 1/29/08; GAO report, 1/29/08).