The number of warning letters sent by the U.S. Food and Drug Administration to corporations has dropped by 50% in the last decade. In 2002, the regulatory agency decided that all warning letters should go through the office of its chief counsel, a move "designed to strengthen the letters and make them legally consistent and credible." But the change may have just succeeded in slowing the process to a crawl. While in 2001 the agency sent out over 1,000 warning letters, in 2007 only 471 made it out the door. Members of Congress and current and former officials with the agency "criticized the change, suggesting it favored industry." Dr. David Kessler, FDA commissioner from 1990 to 1997, said "The number of warning letters has always been one of the surrogate measures of FDA's enforcement performance. It's not the only measure, but any significant drop raises significant questions of what's going on." Other measures of FDA performance are mixed. While plant inspections are down from 22,543 in 2003 to 17,641 in 2006, product recalls are up almost 50%.
- About Us
- Press Room