Report faults FDA drug-safety tracking system: WSJ

NEW YORK (Reuters) - The U.S. Food and Drug Administration is relying on a "dysfunctional" computer system for tracking drug safety as it struggles to upgrade its technology, The Wall Street Journal reported on Saturday, citing a report commissioned by the FDA.

According to the Journal, the report prepared by the Breckenridge Institute consulting firm found that a new system is unlikely to be up and running until 2009 at the earliest, and that the FDA has wasted an estimated $25 million on its efforts.

The report, which has not been made public, says the FDA could have had a new system working in 2005 if it had relied on off-the-shelf software, the Journal said.

FDA safety experts waste an average of 45 minutes per day dealing with inefficiencies and snags caused by the current software, the Journal said, citing the report.

The Journal said a document prepared by FDA officials in response to the report, which is marked as a draft, said it is "riddled with editorial conclusions based on misleading or incorrect facts."

FDA spokesman Doug Arbesfeld said the agency is seeking to upgrade, but that the current system works well.

"This is a viable system today and ... we are looking to move to a second system," Arbesfeld said.