The FDA has failed to create an effective system for tracking the side effects of the drugs the agency approves, setting back its effort to create an effective post-marketing safety program by four years, according to a group of consultants brought in to review its work. Agency staffers lack basic tools needed to track safety, according to a report on the work, and will have to continue to rely on a "dysfunctional" computer system for tracking safety. The FDA has been reeling from years of controversy over drugs like Vioxx, which caused widespread health problems after they were approved for marketing. But efforts dating back to 2003 to upgrade its computer system for tracking adverse events have yet to deliver a successor to the inadequate Adverse Event Reporting System it has in place.
- here's the article on the FDA from The Wall Street Journal (sub. req.)
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