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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
Appendix B
Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
This statement of task pertains to the second phase of a two-phase study. In this phase, an expert committee will refine and test an evidence-based conceptual model to evaluate products and/or product categories addressed by programs of the U.S. Food and Drug Administration (FDA), excluding the tobacco program. The conceptual model and methods will have the capability of evaluating products and/or 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 products and/or 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 products and/or product categories. It will refine the scientific conceptual model (including specification of attributes) from Phase I and will illustrate potential applications of the model in scenarios developed jointly with the FDA.
In carrying out its task, the committee will include the following activities:
In selecting products and/or product categories for evaluation, consider products currently in use and near-term future products expected to come under FDA purview (excluding tobacco and tobacco-related products).
Seek opportunities to assess health consequences in a way that allows results to be compared within and across broad program areas.
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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
Where data or assessment methods are deficient for evaluating a product and/or product category, identify information needs for addressing key uncertainties and present evaluations.
Assess the performance of the evidence-based model for evaluating 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 specific FDA activities or 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.