Number of FDA warning letters have plunged

Over the past 10 years, there was a drop by about half, in fact, Dow Jones reports. A big falloff began in 2002, when the agency began requiring all warnings go through its chief counsel office, which was supposedly designed to make the letters legally consistent and credible, the wire notes. The year before this change took effect, in fiscal year 2001, the FDA issued 1,032 warning letters. In 2006, the FDA sent 538 letters, and in 2007 it sent 471, FDA data show.

Some members of Congress, FDA staffers and former FDA officials have criticized the change, suggesting it favored industry. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,” David Kessler, who was FDA commish from 1990 to 1997, tells Dow Jones. “It’s not the only measure, but any significant drop raises significant questions of what’s going on.” Andy von Eschenbach, the current FDA commish, tells Dow Jones that letters now going out are for transgressions “that we think are going to be important.”

Other findings: the FDA has ordered more product recalls From 1996 to 2000, the agency recalled an average of 3,500 products annually. From 2001 to 2006, that average rose to 4,700 a year. Foreign and domestic plant inspections by the FDA have fallen in the last 5 years, data from the agency’s Web site show. In 2003, the FDA conducted 22,543 inspections. In 2004, that figure was 21,805, in 2005 it was 19,803 and in 2006, the agency inspected 17,641 plants.