Advisers to the Nation on Science, Engineering, and Medicine

National Research Council

Division on Earth and Life Studies

Board on Environmental Studies and Toxicology

500 Fifth Street, NW Washington, DC 20001 Phone: 202 334 2347 Fax: 202 334 2752

February 17, 2009

Dr. Kathleen M. Koehler

Science Policy Analyst

Office of Science and Data Policy

U.S. Department of Health and Human Services

Hubert Humphrey Building, Room 434E 200 Independence Avenue, SW Washington, DC 20201

Dear Dr. Koehler:

At your request, the National Academies convened the Committee on Ranking FDA Product Categories Based on Health Consequences. The committee members were selected on the basis of their expertise in food safety, health economics, medical devices, vaccine safety, pharmacoepidemiology, biostatistics, comparative risk analysis, and decision analysis.

The committee was tasked with developing and applying a conceptual model to rank product categories in FDA program areas on the basis of health risks, both positive and negative aspects (that is, the committee was to consider beneficial aspects of the product categories in the context of possible adverse health consequences). The study was divided into two phases: selection of the model (phase I) and development, refinement, and application of the model to conduct a risk ranking of FDA product categories (phase II). The committee’s task is described in greater detail below. This letter report fulfills the task specified for phase I of this project.

The committee held two meetings. The first included a public session during which FDA staff and other invited experts made presentations. During that session, some indicated that a model that incorporates evaluations of interventions would be particularly valuable. The committee agrees but notes two complicating factors: evaluating baseline risks among product categories is a task of great magnitude and complexity, and it is the nature of interventions to be at the individual-product level and not the product-category or program level. Therefore, the model dictated by the committee’s task is not directly applicable to

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