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Attachment A STATEMENT OF TASK An expert committee will develop and apply an evidence-based conceptual model and methods to rank product categories within the broad types of products addressed by programs of the U.S. Food and Drug Administration (FDA). The conceptual model and methods will focus on ranking product categories according to the potential ranges of magnitude of various health consequences to U.S. users of the products at individual and population levels, taking both adverse and beneficial effects into consideration. The committee will begin by selecting, in consultation with DHHS and FDA, categories of products within FDA mandates for human and veterinary drugs, biologics, medical devices, foods, cosmetics, and products that emit radiation. The committee will then review selected scientific literature bearing on adverse and beneficial health consequences related to these product categories. It will develop a scientific conceptual framework for potential use in guiding product category rankings based on expert judgments and related analysis of the types and potential ranges of magnitude of health consequences to U.S. users of the products (phase I). Using this framework, the committee will perform ranking exercises through expert elicitation and analysis or other appropriate methods (phase II). In carrying out its task, the committee will include the following activities: ï· In selecting product categories for ranking, consider products currently in use and near-term future products expected to come under FDA purview. ï· Seek opportunities to assess health consequences in a way that allows results to be compared across broad product categories. ï· Where data or assessment methods are deficient for evaluating a product category, identify information needs for addressing key uncertainties and present evaluations. ï· Assess the performance of the evidence-based model for ranking the selected product categories and identify next steps for further refinement of the model. ï· In assessing health consequences, consider both the risks and the beneficial aspects of product use, and where applicable and feasible, consider the potential impact on population health if beneficial product use is curtailed through risk reduction strategies. ï· In reviewing selected scientific literature, the committee shall consider the scientific literature broadly, to include, as appropriate, social science and economic literature, grey literature, and regulatory policy literature. The committee will not recommend regulatory strategies, because those choices will entail policy judgments that transcend scientific and technologic considerations. Seven months after initiation of the study, the committee will prepare a brief letter report describing the conceptual model and methods it will use to rank product categories in its final report. 13
