CDER Slated for 283 New Staff in Proposed Fiscal 2009 Budget

The president's fiscal 2009 budget request for the FDA includes an estimated 526 new full-time equivalent employees, 283 for Center for Drug Evaluation and Research (CDER) alone.

Twenty-six new employees would be in the Center for Biologics Evaluation and Research (CBER), 161 would be in the Office of Regulatory Affairs (ORA) and five would be in the FDA Headquarters and the Office of the Commissioner, according to the FDA.

CBER requested an additional $5.6 million in user fees and 18 full-time equivalent employees for its human drug review program, three of whom would review direct-to-consumer (DTC) television advertisements.

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

The FDA is requesting $15 million and 34 full-time equivalent employees for generic drug application reviews. In fiscal 2009, CDER expects to increase its abbreviated new drug application actions and maintain its new generic drug approval performance from fiscal 2007, when it approved 682 new generic drugs.

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 Feb. 14.