President’s FDA budget for 2009 includes 283 new CDER staff

WASHINGTON The president’s fiscal 2009 budget request for the Food and Drug Administration includes—out of 526 new full-time equivalent employees—an estimated 283 for the Center for Drug Evaluation and Research.

CDER requested an additional $5.6 million in user fees and 18 full-time equivalent employees for its human drug review program. Three of these would review direct-to-consumer television advertisements, a growing issue, highlighted recently by accusations of misleading ads for Pfizer’s Lipitor.

Among the new employees, 26 would be in the Center for Biologics Evaluation and Research, 161 would be in the Office of Regulatory Affairs and five would be in the FDA Headquarters and the Office of the Commissioner, according to the FDA.

The fiscal 2009 budget represents a 5.7 percent increase—approximately $2.26 million—more than the $2.27 billion the FDA received for fiscal 2008.

Among its other requestions, the FDA has asked for $15 million and 34 full-time equivalent employees for generic drug application reviews. In fiscal 2007, CDER approved 682 new generic drugs, and has said it expects to maintain this level of approval performance in FY 2009. In addition, CDER expects to increase its abbreviated new drug application actions.

Congressional committees have begun hearings to discuss the proposed budget. The House Energy and Commerce Committee has scheduled a hearing on HHS’ fiscal 2009 budget proposal for this week.