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www.fdanews.com/articles/131982-science-board-fda-8217-s-adverse-event-reporting-system-is-8216-seriously-flawed-8217

Science Board: FDA’s Adverse Event Reporting System is ‘Seriously Flawed’

November 16, 2010
An FDA advisory board review of the agency’s adverse event reporting system (AERS) has found that the system is failing to provide the FDA with the information it needs to detect emerging safety issues. “A very high percentage of these reports lack critical information,” Stephen Spielberg, co-chair of an FDA Science Board subcommittee that conducted a review of AERS, said. As a result, the FDA is often left with only enough information to determine that “a patient took a drug and something happened, and we don’t know if the patient got better,” Spielberg said.
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