McClellan slates FDA adverse event reporting

Mark McClellan, the former US Food and Drug Administration Commissioner who retired last year as the Administrator of the Centers for Medicare and Medicaid Services (CMS, Marketletters passim), has criticized the lack of effectiveness of the FDA's adverse event reporting system.

Speaking to the BioCentury, a specialist biotechnology industry newsletter, Mr McClellan said: "when you have an adverse event reporting system that only captures about 10% of cases, that does it with variable time lags, and with inconsistently collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern." The former FDA chief suggested that the agency should pool data from both public and private databases to improve its ability to monitor adverse events.