Fifth, expert judgment and data were inextricably intertwined in how the committee completed each of the case studies. For some case studies, the committee did not have much direct information; in others, adequate data were available. In all cases, assumptions had to be made to interpret the data and complete the attribute table. Although the committee recognizes FDA’s strong preference for “data” over “expert judgment” as the basis of any estimates or decisions, it is important to recognize that expert judgment is always present. When decisions must be made immediately, the committee’s suggested approach can provide useful information about the public-health consequences of various options in a clear and consistent way on the basis of the best information available at the time the decision must be made. When there is ample time to evaluate and compare decision options, the suggested approach can highlight where additional information would help to differentiate between options (that is, it can help to target information collection) and provide a clear and consistent way to compare the options.


To aid decision-making, FDA should consider using the concepts defined by the risk-characterization framework and particularly the risk attributes defined in the present report for discussing risk-related aspects of various decisions. Considering the outcomes of alternative decisions in terms of the attributes identified here will begin to establish consistency in risk vocabulary throughout the agency. As FDA begins to use the risk-characterization framework, it may find that some aspects of the approach need to be modified. Such modifications are entirely appropriate; the approach should evolve to meet FDA’s needs as staff gain experience in implementing it.

The committee recognizes that precise predictions of the outcomes of different decisions based on the risk attributes may be difficult to develop. Data may be lacking, and scientists may be uncomfortable in making, or even unwilling to make, the necessary judgments to estimate the risk attributes. However, the committee emphasizes that decisions in which risk information could be valuable are made regularly and recommends that FDA use internal or external experts who are trained in and comfortable with decision analysis, risk assessment, risk management, and specifically the assessment of uncertainties to facilitate the use of the committee’s framework.

Changing the organizational culture and its approach to decision-making is a daunting task in any organization. However, FDA is confronted with complex decisions every day, and new approaches are needed to meet the challenges of the future. Using the risk-characterization framework to evaluate the effects of different decisions in terms of the risk attributes described in this report can provide information that is useful in choosing among alternatives.

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