The U.S. Food and Drug AdministrationÃ¢â‚¬â„¢s (FDA) is facing serious technological issues related to its drug-safety computer-tracking system, according to a story in the Wall Street Journal. The JournalÃ¢â‚¬â„¢s claim is based on a classified report commissioned by the FDA and produced by a consulting firm called the Breckenridge Institute.
According to the JournalÃ¢â‚¬â„¢s interpretation of the report, the FDA has Ã¢â‚¬Å“bungled its effort to build a new system for detecting the side effects of medicines after they go on the marketÃ¢â‚¬Â and Ã¢â‚¬Å“must continue to rely on its existing Ã¢â‚¬ËœdysfunctionalÃ¢â‚¬â„¢ computer system as a primary tool for tracking the safety of medications sold in the U.S.Ã¢â‚¬Â The paper quoted the report as saying that the flawed system is Ã¢â‚¬Å“frustrating and undermining the post-marketing drug safety work.Ã¢â‚¬Â
The report implies that much of the problem stems from the FDAÃ¢â‚¬â„¢s desire to build its own software technology, as opposed to using Ã¢â‚¬Å“off-the-shelfÃ¢â‚¬Â software. The agency intends to implement a new software system, but the development of that system is years behind schedule, meaning that a new system will probably not be in place for at least two years possibly more.