Activity

Activity Description

This statement of task pertains to the second phase of a two-phase study (see BEST-K-08-03-A). In this phase, an expert committee will refine and apply an evidence-based conceptual model 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 consult with FDA to finalize product categories that are within FDA mandates for human and veterinary drugs, biologics, medical devices, foods, cosmetics, and products that emit radiation. The committee will continue to review selected scientific literature and consult with FDA to determine adverse and beneficial health consequences related to the selected product categories. It will refine the scientific conceptual model from Phase I and will perform ranking exercises through expert elicitation and analysis or other appropriate methods. In carrying out its task, the committee will include the following activities: - In selecting product categories for ranking, consider products currently in use and near-term future products expected to come under FDA purview. - Seek opportunities to assess health consequences in a way that allows results to be compared across broad product categories. - Where data or assessment methods are deficient for evaluating a product category, identify information needs for addressing key uncertainties and present evaluations. - Assess the performance of the evidence-based model for ranking the selected product categories and identify next steps for further refinement of the model. - 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. - 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. The committee has prepared a brief letter report that describes the conceptual model and methods it will use to rank product categories in its final report. The project is sponsored by the U.S. Department of Health and Human Services. The approximate start date for the project is June 5, 2008. For more information