The agency has released its 2006 progress report and, not surprisingly, last year wasn’t such a distinguished one, at least that’s what the FDA’s own charts show us.

For instance, the number of inspections of food and drug manufacturers declined: in 2002, 18,572 inspections took place and the number rose to 22,543 the following year. But then the number of inspections began falling each year, reaching just 17,641 in 2006.

Similarly, the number of warning letters issued between 1996 and 2006. Back in 1999, 1,038 letters were issued and the number bobbed up and down for a few years before reaching 1,154 in 2000. A steep annual decline followed, until just 538 letters were issued last year. Of those, 213 were about food safety, 66 referred to drugs and 22 were about biologics.

“The year 2006 can be distinguished as a year of transformation, highlighted with centennial celebrations commemorating FDA’s remarkable history as a world leader in public health,
writes David Elder, who heads the Office of Enforcement. “As you view the statistics and read the articles, I hope you will share my pride for all that was accomplished in 2006.”

Okay, numbers don’t always tell the whole story. But these are precipitous declines and don’t justify a celebration, 100th anniversary or not. Of course, FDA commish Andy von Eschenbach has a solution: raise user fees so drugmakers will pay more to the agency monitoring them. Maybe the unit should be renamed Office of Disembowelment.

The FDA report;
Inspection chart;
Warning Letter chart.

[tags]FDA[/tags]