Decrease in Food and Drug Administration Warnings
According to a recent report released by the House Government Reform Committee, the number of serious "warning letters" by the Food and Drug Administration (FDA) has decreased by almost 50% during the past five years. In some cases, the FDA rejected recommendations by on-site investigators that violations had led to serious injuries or deaths. The report was released by Congressman Henry Waxman's office on June 26, 2006. "Waxman requested the study because of reports that FDA inspectors who identified problems at Chiron Corp's flu-manufacturing plant in England were overruled by their supervisors. British drug authorities closed the plant because of manufacturing problems, leaving the United States with a major shortage of flu vaccine for the winter of 2004-2005," according to a related Washington Post story.
Three key conclusions of the report include:
1) FDA enforcement actions have declined by over 50% during the past five years.
2) FDA headquarters officials have routinely rejected the enforcement recommendations
from agency field inspectors.
3) FDA's recordkeeping and case tracking practices are inadequate. The FDA does not
track enforcement recommendations.
In response to the report by the House Government Reform Committee, the Office of Enforcement Director David Elder released the following statement: "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 focus on combating the greatest public health risks and maximizing our deterrent effect against potential violators."
The report by Waxman's office was released just before the 100th anniversary of FDA. Two watchdog groups plan a news conference to highlight FDA's current failures.