FIGURE 7-2 History of CDER staffing.

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

2003). These restrictions have contributed to a troubling resource imbalance between OND and other CDER units (e.g., postmarketing safety activities, compliance). Some effects or correlates of the resource imbalance between OND and the Office of Drug Safety (ODS)/ Office of Surveillance and Epidemiology (OSE) are discussed in Chapter 3.

The committee recognizes that the recommendations in this report come with a price tag, one that is most likely large and believes it would be ill-advised to expect CDER to take on the many new responsibilities called for in this report without new funds for strengthening the number and expertise of staff, for intramural and extramural research, and for information technology. On the other hand, the committee believes that full implementation of the recommendations it offers is essential. Although some of the recommendations are more far-reaching than others, the committee believes each of its recommendations will serve to improve the drug safety system.

For the past 15 years, user fees have supported a steadily increasing share of CDER’s work. Many have argued that relying so heavily on industry funds is inherently inappropriate and damaging to the reputation and functioning of CDER, indeed, of any regulatory entity. Some CDER staff, as well as some public advocates (Wolfe, 2006) have expressed discomfort with this funding (DHHS and OIG, 2003; GAO, 2006; IOM Staff Notes,

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