FDA’s Adverse Drug Reaction System Blasted in a Report that FDA Commissioned, WSJ Reports

The Wall Street Journal  (click to access the article---subscription required) here) has just reported on a report that has not yet been released to the public, that finds serious problems with FDAs Adverse Drug Reaction reporting system. 

Disturbing, since the Agency needs new IT platforms, and has requested an increase in user fees to pay for more IT work.  On the other hand, it has just hired a new CIO. Let he who has never suffered from a botched IT project or been burned by an IT consultant, cast the first stone. Below, an excerpt from the WSJ article.   The Food and Drug Administration has bungled its effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself. As a result, the agency must continue to rely on its existing dysfunctional computer system as a primary tool for tracking the safety of medications sold in the U.S., according to the November 2006 report, which hasnt been made public. The situation is frustrating and undermining¦the post-marketing drug safety work of its staff because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements, says the report. It was prepared by the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo.