Drug safety tracking "failings" at FDA

The US Food and Drug Administration has found itself at the center of a row over claims that its adverse effect reporting system software wastes at least 45 minutes per day of agency administrators' time because of "dysfunctional" equipment. The allegations were made in a report, commissioned by the FDA but not made public, written by the Breckenridge Institute, a research and consulting firm. The FDA disputes the claims, arguing that the Wall Street Journal, which revealed the contents of the report, has reached "editorial conclusions based on misleading or incorrect facts."

According to the leaked document, the adverse response recording procedures are overwhelmed by over 400,000 reported incidents per year. The FDA is alleged to have "wasted" $25.0 million since 2003 trying to upgrade the reporting system, largely because of attempts to integrate all FDA regulated products (including both drugs and medical devices) on one system, instead of purchasing an "off-the-shelf" software product that would have cost $4.5 million in 2005. A new system is unlikely to be in place until 2009 at the earliest, according to the Breckenridge Institute.

Douglas Throckmorton, Deputy Director of the FDA's Center for Drug Evaluation and Research, 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."