FDA enforcement activity declines

An investigation by the Democratic staff of the House Committee on Government Reform finds a sharp drop in FDA enforcement actions over the past five years. The number of warning letters issued for violations of federal requirements dropped to a 15-year low, from 1,154 in 2000 to 535 in 2005. Over the same period, the number of seizures of mislabeled, defective, and dangerous products dropped 44%. The investigation, which was initiated by Rep. Henry A. Waxman (D-Calif.), also finds that FDA headquarters officials in at least 138 cases ignored recommendations of agency field inspectors concerning violations of agency rules. The report also concludes that FDA fails to comply with its own requirements for documenting agency enforcement decisions. When the committee requested enforcement documents, FDA's response was "haphazard, incomplete, and untimely," the report says.