Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks (2009) / Chapter Skim
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Letter Report
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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.
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The report reflects the consensus of the committee and has been reviewed in accordance with standard National Research Council review procedures. Sincerely, Robert Lawrence, Chair Committee on Ranking FDA Product Categories Based on Health Consequences 2
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, the early CRA efforts led to questions about how best to facilitate comparisons and identify useful attributes for characterizing risks or risk-reduction opportunities. The EPA SAB noted that ranking risks or ranking the alternative actions that might be available for reducing risks would probably yield different rankings (EPA SAB 1990)
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users of the products at the individual level and the population level, taking both adverse and beneficial effects into consideration. To accomplish its task, the committee was to include the following activities: consult with the sponsor to select FDA product categories to be ranked; consider products currently in use and near-term future products expected to come under FDA purview; review selected scientific literature bearing on adverse and beneficial health consequences; consider the scientific literature broadly to include social-science and economics literature, gray literature, and regulatory-policy literature; seek opportunities to assess health consequences in a way that allows results to be compared among broad product categories; identify information needed to address key uncertainties; assess the performance of the evidence-based model for ranking the selected product categories and identify next steps for model refinement; and where applicable and feasible, consider the potential effects on population health if risk-reduction strategies curtail the beneficial use of products.
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RANKING MODEL Conceptual Framework On the basis of recent literature, the committee concluded that the best approach to ranking FDA product categories on the basis of health risk is to use a conceptual framework similar to that described by Florig et al.
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As a preliminary scoping exercise, the committee selected five attribute groups related to exposure, severity of effect, ability to anticipate and prevent adverse events, ability to mitigate adverse events, and benefits of products or product categories. Each group contains multiple specific attributes, which are shown in Table 2.
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TABLE 1 Suggested Initial List of Product Categories for Ranking Provided by FDA Program Area Product Categories Food, cosmetics, and dietary supplements Food Produce Eggs and dairy Processed food Seafood Cosmetics Dietary supplements Food and color additives Drugs and biologics regulated as drugs Over-the-counter drugs Diagnostic prescription drugs Preventive prescription drugs Prescription drugs that are life-sustaining Prescription drugs for treatment for symptoms or improvement in quality of life Prescription drugs that are used cosmetically Biologic products other than those regulated as drugs Vaccines Blood and tissue products In vitro diagnostics related to donor testing Devices regulated as biologics Allergenics Cell and gene therapy Veterinary products Approved animal drugs Unapproved animal drugs Animal feeds Pet food Medical devices and radiation-emitting products Critical devices for professional use Noncritical devices for professional use Noncritical devices for lay use Nonmedical radiation-emitting devices Patient cables and lead wires 7
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The committee considered six specific attributes to characterize the ability to anticipate and prevent adverse events. Quality of scientific understanding is related to product knowledge, that is, 8
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The attribute history of problems and corrective actions reflects the availability of information on such events as adverse reactions and manufacturing defects and whether actions have been needed to address problems. The attribute availability of quality standards, guidelines, or standard operating procedures attempts to capture the idea that manufacturing products in accordance with standards, guidelines, or standard operating procedures improves FDA's ability to control product quality and minimize adverse events (for example, the availability of practices to produce uniform, high-quality products and the limits of the practices)
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Creating robust attributes that are systematically and accurately measured across the wide array of FDA regulatory responsibilities will focus agency thinking and help to communicate the considerations underlying agency decision-making to a broad range of stakeholders. Steps D and E: Conducting the Ranking and Analyzing the Results Once the attributes are fully defined for each product category, the ranking will begin, probably with at least two approaches: a holistic ranking based on the rankers' overall preferences and a ranking based on application of a formal mutiattribute model.
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NEXT STEPS The committee has proposed a conceptual model for ranking FDA product categories and has suggested preliminary categories and risk attributes. The committee emphasizes that participation of FDA staff in each program area is essential for the development of a successful and useful model.
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comparing risk among disparate categories, and its recommendations, with input from FDA, will help to identify a framework for making advances in FDA management processes and decisions. Attachments: A Statement of Task B Committee Membership C Bibliography D Acknowledgment of Reviewers 12
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