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Project Title:
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Ranking FDA Product Categories Based on Health Consequences, Phase I
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PIN:
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BEST-K-08-03-A
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Major Unit:
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Division of Behavioral and Social Sciences and Education
Division on Earth and Life Studies
Institute of Medicine
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Sub Unit:
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Board on Environmental Studies & Toxicology
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RSO:
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Mantus, Ellen
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Subject/Focus Area:
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Project Scope
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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 study will be conducted in two phases. For phase I, the committee will begin by selecting, in consultation with HHS 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.
In carrying out its task for phase I, 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.
- 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.
For phase I, seven months after study initiation, the committee will prepare a brief letter report that describes the conceptual model and methods to rank product categories. The scope of phase II will be described on the completion of phase I. The committee may be reconstituted for phase II (see BEST-K-08-03-B).
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.
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Project Duration:
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7 months
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Provide FEEDBACK on this project.
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Contact the Public Access Records Office to make an inquiry, request a list of the public access file materials, or obtain a copy of the materials found in the file.
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Tel:
202.334.2000