FDA is using a "dysfunctional" computer system to track the safety of prescription drugs

Mar 5 2007

FDA is using a "dysfunctional" computer system to track the safety of prescription drugs after they reach the market, and efforts to establish a new system to track adverse drug events have been delayed by at least four years, according to a November 2006 report commissioned by the agency, the Wall Street Journal reports.

The report -- which was prepared by the Breckenridge Institute, a research and consulting firm -- has not been released publicly. According to the report, FDA regulators waste an average of 45 minutes per day because of inefficiencies and problems with the agency's Adverse Event Reporting System software. The report states that the system is overwhelmed by the more than 400,000 adverse event reports submitted each year. The system is "frustrating and undermining ... the postmarketing drug safety work" of FDA staff "because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements," according to the report. FDA since 2003 has been working to upgrade the technology, but a new system is not expected to be functioning until 2009 at the earliest, the report states. The report says that had the agency moved forward with a plan to use off-the-shelf software, it might have had a new system working in 2005 at a one-time cost of $4.5 million. However, in June 2004, the agency's Office of Information Technology advocated a system that could track adverse events from all products regulated by the agency, including medical devices. The office also commissioned further analysis, which the report contends "did not add any value" and contributed to the new system's delay. According to the report, FDA has wasted $25 million on efforts to develop a new system. The report cites "lack of effective leadership and management" within the information technology office as contributing to the problems.

FDA Response
FDA officials in a draft document responding to the report said it is "riddled with editorial conclusions based on misleading or incorrect facts." Douglas Throckmorton, deputy director of the agency's drug center, said the current Adverse Event Reporting System is "working" despite "exploding" amounts of data. He added, "Is it the best it can be? Of course not." FDA wants to create a replacement system "as quickly as anyone else does, but we want it to be done right." As for the delay, Throckmorton said that "based on what I know, those timelines were caused by the complexity of it, the need to get it right and the need to consider integration into a larger system," rather than by strategic or management errors.

Legislative Response
Meanwhile, Senate Finance Committee Chair Max Baucus (D-Mont.) and Sen. Charles Grassley (D-Iowa) have sent a letter to FDA concerning the computer system. Baucus said the report raises "troubling questions," and Grassley said the report indicates a "broken down process" at the agency. The issue also is being examined by Michigan Democratic Reps. John Dingell (Mich.) and Bart Stupak (Mich.) in the House Energy and Commerce Committee (Wilde Mathews, Wall Street Journal, 3/3).