The FDA’s enforcement of food and drug laws has dropped dramatically over the past five years, and the FDA routinely rejects enforcement recommendations of its staff, according to a report by the House Committee on Government Reform. According to the report, commissioned by Rep. Henry Waxman, D-Calif., the number of warning letters issued by the FDA fell by over 50% in the past five years, from 1,154 in 2000 to 535 in 2005--a 15-year low. The largest decrease in warning letters came from the department responsible for ensuring the safety of medical devices. Better compliance by manufacturers does not account for fewer warnings, because the number of violations remained constant. Rather, the FDA overruled field inspectors and failed to bring enforcement actions in 138 cases involving drugs and biological problems, according to the study. The report also called the FDA’s responses to requests for records of enforcement decisions “haphazard, incomplete, and untimely.”
The FDA says it has been concentrating on products that present high risk to consumers and that it has aggressively prosecuted firms who have violated the law, reports The Washington Post. “FDA enforcement cannot be properly judged by counting the number of actions taken by the agency,” Office of Enforcement Director David Elder said in a statement. “FDA has increasingly used an enforcement strategy based on efficient risk management principles that focus on combating the greatest public health risks and maximizing our deterrent effect against potential violators.”
