2005–2006). The problem is mainly one of logistics, timing, and complying with the regulations for using special government employees, including the process for considering conflict of interest.

Some in the agency have suggested that the review deadlines have forced them to plan for advisory committee input too early in the process, before the questions to be presented have been fully developed and the appropriate expertise is fully recognized, and hence reduced the effectiveness of this important agency resource. Data also show that from 1998 to 2001 there was a 50 percent reduction in the agency’s use of advisory committees for approved NMEs and priority drugs (DHHS and OIG, 2003). NMEs and in particular priority-rated drugs are the most innovative and complex new drug products and have been shown to be associated with increased drug risks (Olson, 2004). Although reduction in product submissions has contributed in part to the decline in use of advisory committees, FDA managers indicate that they have little time to hold advisory committee meetings within the current review deadlines (DHHS and OIG, 2003:11–12). The reduction in the use of the committees has important implications for the agency. Reduction in input from informed independent experts may reduce the quality of the decisions and thereby lead to a reduction in public confidence in the agency. Reduction in use of advisory committees also reduces the public’s role in FDA decisions and reduces the transparency and perhaps the credibility of the regulatory decisions in the public’s mind.

4.8: The committee recommends that FDA have its advisory committees review all NMEs either prior to approval or soon after approval to advise in the process of ensuring drug safety and efficacy or managing drug risks.

The committee recognizes that it might be impossible for all NMEs to be reviewed by an advisory committee before approval, because of the time constraints described elsewhere. However, it believes that such review is important and allows for review of the drug after approval if preapproval review is not possible. If FDA is granted the authorities that the committee believes it should have (as described in Chapter 5), there will ample opportunity for useful input even after approval. Careful review of phase 4 study designs by advisory committees and/or by the public-private partnership should obviate concerns that giving CDER more control over phase 4 studies could be wasteful and inefficient. The goal is for better-designed studies that will be conducted and answer needed questions.

The committee has concerns about the composition of product-specific advisory committees. Traditionally a statistician serves on these committees, but other than Drug Safety and Risk Management (DSaRM) Committee, there is no guidance related to epidemiology or other public health expertise.

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