A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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Appendix A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks
Appendix A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks
Pages 149-176
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From page 149... ...
Appendix A Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks Committee on Ranking FDA Product Categories Based on Health Consequences Board on Environmental Studies and Toxicology Division on Earth and Life Studies National Research Council Institute of Medicine 149
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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
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to review the report, and the SAB released a follow-up report, Reducing Risk (EPA SAB 1990) , which endorsed the broad comparative risk analysis (CRA)
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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 cate
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This letter report fulfills phase I of the project. To accomplish its task, the committee held a public session at its first meeting, during which it heard presentations from FDA staff in the various program areas and from experts in the fields of decision analysis and CRA.
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Phase I Phase II PRELIMINARY PRELIMINARY FINAL Step A: Define the Step A: Define the FDA product FDA product categories to be ranked categories to be ranked Step E: Describe Step C: Describe Step D: Select the issues the categories in participants and identified and terms of perform the risk the resulting attributes rankings rankings PRELIMINARY FINAL Step B: Identify the risk Step B: Identify the attributes that should risk attributes to be be considered for each considered for each of of the product the product categories categories FIGURE 1 Framework of health-risk ranking model. Source: Adapted from Florig et al.
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From page 156... ...
. Although the committee noted that the categorization could alternatively focus on type or magnitude of hazard, it concluded that the final selection of the product categories for ranking will require further input from FDA staff who have specific expertise in the FDA products.
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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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158 A Risk-Characterization Framework for Decision-Making at FDA TABLE 1 Suggested Initial List of Product Categories for Ranking Provided by FDA Program Area Product Categories Food, cosmetics, and dietary Food supplements Produce Eggs and dairy Processed food Seafood Cosmetics Dietary supplements Food and color additives Drugs and biologics regulated as Over-the-counter drugs 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 Vaccines regulated as drugs 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- Critical devices for professional use emitting products Noncritical devices for professional use Noncritical devices for lay use Nonmedical radiation-emitting devices Patient cables and lead wires
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Appendix A 159 TABLE 2 Risk Attributes for Model for Ranking FDA Product Categories on the Basis of Health Risk Attribute Groups Risk Attributes Exposure Exposed population Cumulative incidence Prevalence Vulnerable groups Cluster Severity of effect Mortality Morbidity Vulnerable groups Catastrophic event Diffusion effects beyond intended usea Animal health Ability to anticipate and prevent Quality of scientific understanding adverse events Availability of substitutes History of problems and corrective actions Availability of quality standards, guidelines, or standard operating procedures (quality assurance and quality control, good manufacturing practices) Variability in product composition or performance Vulnerability of supply chain Ability to mitigate adverse events Availability of substitutes Availability of corrective actions Traceability Latency Ability to recall Reversibility Product benefits Mortality reduction Morbidity reduction Efficacy and effectiveness Animal welfare a Diffusion effects is an attempt to capture effects on people who do not use the product.
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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, background information available on a product, the number of scientific studies, and the quality of the studies.
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For example, the "Ability to anticipate and prevent adverse events" set, which currently has six specific attributes, will probably contain only one or two in the final version. If those six attributes were all described by using binary variables, 64 combinations would be possible.
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From page 162... ...
For some attributes, such as those measuring mortality risks, a summation across all items in the product category may capture the relevant values, with upper and lower bounds on the quantified values providing an indication of the uncertainties in the calculations. However, because of the heterogeneity of some of the product categories, difficulty will arise in assigning unique values for many attributes.
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From page 163... ...
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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Regardless of the specific uses, determining the level of agreement among the rankers could provide valuable insights that are not now available to FDA. NEXT STEPS The committee has proposed a conceptual model for ranking FDA product categories and has suggested preliminary categories and risk attributes.
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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.
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166 A Risk-Characterization Framework for Decision-Making at FDA The committee will not recommend regulatory strategies, because those choices will entail policy judgments that transcend scientific and technologic considerations. Seven months after initiation of the study, the committee will prepare a brief letter report describing the conceptual model and methods it will use to rank product categories in its final report.
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From page 167... ...
He is a member of the Institute of Medicine and has served on numerous National Academies committees, most recently the Committee on Adolescent Health Care Services and Models of Care for Treatment, Prevention, and Health Development and the Committee to Evaluate Measures of Health Benefits for Environmental, Health,
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Dr. Diez-Gonzalez teaches courses in food safety and food microbiology.
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She has served on U.S. Department of Agriculture expert review panels, including the Panel on Measuring Food Security in the United States and the Panel on the Health Eating Index.
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Dr. Miller has served on many national and international government and professional-society advisory committees, including the National Advisory Environmental Health Sciences Council of the National Institutes of Health and the Joint World Health OrganizationUnited Nations Food and Agricultural Organization Expert Advisory Panel on Food Safety.
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He is a member of the Advisory Panel for Research of the Association of American Medical Colleges and has chaired the Executive Committee of the HMO Research Network, the Epidemiology and Disease Control Study Section of the National Institutes of Health, and the Steering Committee of the Centers for Disease Control and Prevention Office of Health Care Partnerships. He has served on several National Academies committees and is a member of the Roundtable on Evidence-Based Medicine.
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2005. Judgment-based risk ranking for food safety.
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Society of Risk Analysis Annual Meet ing Applications of Risk Analysis in Industry and Government, December 3-6, 2000, Washington, DC.
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2004. Eco logical risk ranking: Development and evaluation of a method for improving pub lic participation in environmental decision making.
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The review of the report was overseen by the review coordinator, Lauren Zeise, California Environmental Protection Agency, and the review monitor, John C Bailar, III, University of Chicago.
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