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Ranking FDA Product Categories Based on Health Consequences, Phase II

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With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process.

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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 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. - 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.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.Note: The project scope was revised and the final version is shown above(09/28/2009).

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Conflict of Interest Disclosure



Disclosure of Conflict of Interest: David O. Meltzer

In accordance with Section 15 of the Federal Advisory Act, the “Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.” A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for the committee to accomplish the tasks for which it was established its membership must include, among others, at least one person who has expertise in medical cost-effectiveness analysis in the context of the pharmaceutical industry. To meet the need for this expertise and experience, Dr. David O. Meltzer is proposed for appointment to the committee even though we have concluded that he has a potential conflict of interest because he is currently engaged in consulting for companies that develop products that could be regulated by FDA.

As his biographical summary makes clear, Dr. Meltzer is a nationally recognized expert on health economics and public policy, specifically the theoretical foundations of medical cost-effectiveness analysis and the effects of different factors on the cost of quality of care. He has extensive experience in the use of medical cost-effectiveness analysis in the pharmaceutical industry and his expertise provides a critical viewpoint that complements the comparative risk analysis and decision analysis experts on the committee. This combined expertise is essential for the refinement and application that will occur to the conceptual model during phase II of this study. We believe that Dr. Meltzer can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Dr. Meltzer who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.


Disclosure of Conflict of Interest: Susan S. Ellenberg

In accordance with Section 15 of the Federal Advisory Act, the “Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.” A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for the committee to accomplish the tasks for which it was established its membership must include, among others, at least one person who has expertise in biostatistical analyses related to the design and analysis of clinical trials and the assessment of medical product safety and who has experience with FDA and the pharmaceutical industry. To meet the need for this expertise and experience, Dr. Susan S. Ellenberg is proposed for appointment to the committee even though we have concluded that she has a potential conflict of interest because she is currently engaged in consulting for companies that develop products that could be regulated by FDA.

As her biographical summary makes clear, Dr. Ellenberg is a nationally recognized expert in the field of biostatistics and is an expert on issues related to the design and analysis of clinical trials and the assessment of medical product safety. This expertise, together with her previous position at the Center for Biologics Evaluation and Research at FDA and her work with the pharmaceutical industry, provides the committee with a unique perspective that has assisted the committee during phase I and will be essential to its work through phase II. We believe that Dr. Ellenberg can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Dr. Ellenberg who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Sponsors

Department of Health and Human Services

Staff

Ellen Mantus

Lead

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