July 11, 2006
FDA enforcement actions decline sharply, report says
The number of FDA enforcement actions targeting drug safety problems and misleading claims has fallen sharply since 2000 even though violations have not, according to a study released by Rep. Henry Waxman, a California Democrat. The study claims that the FDA issued 535 warning letters in 2005, a 54% decline from 1,154 in 2000. Over the same period, the number of violations reported by FDA inspectors in the field dipped just 1%, from 6,334 in 2000 to 6,268 in 2005, the report said. The report is the result of a 15-month investigation that included a review of thousands of pages of internal agency enforcement records, according to a statement from Waxman’s office. The FDA’s head of enforcement, David Elder, said in a published report, “FDA enforcement cannot be properly judged by counting the number of actions taken by the agency. FDA has increasingly used an enforcement strategy, based on efficient risk-management principles, that focuses on combating the greatest public health risks and maximizing our deterrent effect against potential violators.” The Waxman report comes as lawmakers in the Senate draft legislation aimed at strengthening the FDA’s drug safety program by requiring the agency and drugmakers to develop an individual safety plan for every new drug and to follow through with studies and monitoring after approval.