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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
well as the risks from each. After focusing on the decisions that the comparison might be used to support (that is, allocation of food-inspection resources), the committee determined that the focus should be on the risks and, more specifically, on the risks that could be averted by improved or more rigorous inspections. The committee notes, however, that the targeting-decision case study did not explicitly compare the health consequences of the current inspection processes with those of changes in the inspections; if that decision were to be evaluated, additional steps would be necessary.
The decision analysts on the committee were able to focus the subject-matter experts on a relatively constrained decision context, to identify the sequence of information needs, and to assist the subject-matter experts in making judgments about the array of possible effects on the basis of sparse data. The decision analysts, of course, could not provide the specialized and detailed knowledge necessary to identify and recognize the most relevant data for a specific decision context. The committee was hampered in one case study (the effects of potential melamine contamination of infant formula) by the lack of detailed subject-matter expertise among the committee members; as a result, the committee had much less confidence in the estimates of the risk attributes of the case study than in the estimates of the other three case studies.
In all case studies, the discussions and interactions between committee members with different backgrounds and expertise were critical for the use of the risk-characterization framework. On the basis of its experience, the committee concludes that FDA will benefit from including multiple stakeholders in its decision-making process, from defining decisions to gathering information and ultimately formulating conclusions. Just as shared decision-making (Charles et al. 1997) is beneficial for medical treatment decision-making (including information-sharing and consensus-building), it will be beneficial for FDA strategic decision-making.
Defining the Decision Context
The committee found that it was critical in each case to define the decision options to be evaluated and compared clearly, so that appropriate risk information for the decision-making process could be obtained. In all cases, decision-analytic structuring was used to organize thinking about the decision context. Analytic reasoning and basic structuring tools, such as influence diagrams (see, for example, Figure 3-2), were used to identify the various factors that needed to be considered to develop estimates of the public-health consequences of the alternative decision options.
For mitigation-selection decisions, as illustrated with the vaccine-withdrawal case study in Chapter 3, defining clear and distinct decision options to be compared was straightforward. Although the example was deliberately chosen to be a simple comparison of a yes-no variety, it would have been easy to