component of its mission. Continued resource shortages will impede the agency’s ability to use new and future scientific and technological advances in drug research across the lifecycle. In particular, the limited resources could impede the agency’s ability to detect risks of new drugs in a timely fashion, analyze emerging drug safety data, and effectively communicate that information to the public in the ways envisioned in the committee’s report. For fiscal year 2006, CDER’s enacted budget was $517,557,000, with $297,716,000 from congressional appropriations and $219,841,000 (or 42.5 percent of the total budget) from user fees (see Figures 7-1 and 7-2 for more information on trends in CDER funding and staffing).

Although PDUFA has facilitated substantial expansion of CDER staff, especially in the Office of New Drugs (OND), growth has been largely to shorten review times and improve related processes, including interactions with industry representatives and the development of guidances, rather than strategic with respect to the full breadth of functions and disciplines needed to operate the largest center of a world-class regulatory agency. PDUFA I and II did not allow for the use of PDUFA funds to support postmarketing drug safety work. PDUFA III allowed for a very restricted amount of funds to be used for very specific and narrow postmarketing safety work (postmarketing surveillance of drugs for 2–3 years after approval) (FDA,

FIGURE 7-1 History of CDER funding.

SOURCE: PDUFA White Paper (FDA, 2005b).



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