March 3, 2007--An FDA-commissioned report prepared by the Breckenridge Institute says the agency delayed implementation of a new system for detecting side effects of marketed drugs by at least four years, predicting that a new drug-tracking system is unlikely until at least 2009 and estimating the FDA has wasted $25 million. 

According to the report, by June 2004 the FDA was considering a package of off-the-shelf software that might have allowed a new drug-tracking system to be in place in 2005 at a cost of about $4.5 million. Instead, the report says an official in the drug center's information-technology office favored a system that could track adverse events from all products regulated by the FDA and commissioned further analysis, which the report contends "did not add any value" and helped delay a new system. The Wall Street Journal (Subscription required)