FDA’s top enforcer has warned that cuts to the agency’s budget now being contemplated by some in Congress could result in as many as 2,000 fewer domestic and foreign inspections of pharmaceutical plants and food processing facilities, and up to 9,000 fewer border inspections for FDA-regulated drug and food imports.
Associate commissioner for regulatory affairs Dara Corrigan told a meeting of the Alliance for a Stronger FDA that the magnitude and increasing complexity of the task confronting her office can be seen in the past year’s 200 recall “events” involving 860 products, and consisting of 340 million product units—all with a staff of 19 product recall managers.
As a result of a FY 2008 supplement to FDA’s budget, augmented by FY 2009 appropriations and a continued supplement in FY 2010, Corrigan’s office was able to increase its inspectional force by approximately 800 new investigators, Corrigan said. However, she indicated that subsequent staff attrition, including retirements, has reduced this initial increase in staff by more than half.
From the September 01, 2011 Issue of MM+M - Medical Marketing and Media
