June 26, 2006

The FDA's own enforcement reports show it to be an agency under increasing pressure to do more with less -- the number of warning letters is dropping even as recalls skyrocket, sources say.

The FDA required 5,338 recalls last year, according to enforcement numbers obtained by FDAnews. The recalls represent an 11-year high and represent a significant increase from the 4,670 issued in 2004, FDA documents show. The recall numbers are available at: http://www.fda.gov/ora/about/enf_story/ch10/Recalls.pdf (http://www.fda.gov/ora/about/enf_story/ch10/Recalls.pdf).

Meanwhile, the number of Form 483 warning letters is continuing to drop, with the agency issuing 535 in 2005 as compared with 725 the previous year. The warning letter data is available at: http://www.fda.gov/ora/about/enf_story/ch10/10yrWL.pdf (http://www.fda.gov/ora/about/enf_story/ch10/10yrWL.pdf).

These numbers illustrate an agency that is allowing more mistakes to reach the market, requiring an ever greater number of recalls, Gordon Richman, vice president of strategic compliance and general counsel of the consulting firm EduQuest, told FDAnews. The numbers also are a sign of rising quality system or manufacturing errors in industry, which allow flawed products to get into the market, he said.

This data "doesn't paint a very encouraging picture" as to where the agency's enforcement efforts are headed, Richman added. But both he and a consumer activist who assessed these numbers stressed that the FDA was not to blame -- Congress is.

"This is not the agency's fault, it is Congress' fault in not adequately funding the agency," the consumer advocate, who asked not to be named, added. Specifically, Congress and the president's budgets are not keeping up with the rate of inflation and the increased responsibilities the FDA must address, Richman and the source said. The agency needs more investigators and an updated information technology system, including databases, that helps to better track problems in medical product development, the consumer advocate added. (http://www.fdanews.com/did/5_124/)