A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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Pages 3-10
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From page 3... ...
This report, prepared by the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, in response to the request from FDA and DHHS, describes a risk-characterization framework that can be used to evaluate and compare the public-health consequences of different decisions concerning a wide variety of products. The framework presented here is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them.
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From page 4... ...
The framework offered here builds on the substantial amount of work that has been done on methods for estimating the humanhealth consequences associated with various risks, hazards, and decisions. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for FDA decision-making.
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From page 5... ...
Consideration of the traditional risk-assessment paradigm gave rise to one set of attributes to characterize health risks. Thus, the committee defined exposed population, mortality, and morbidity as the attributes to use to determine the number, type, and rate of occurrence of adverse health effects that could result from implementation of a particular decision option.
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From page 6... ...
Ability to mitigate adverse health effects refers to the ability of institutions to manage, reduce, or otherwise control any expected or unexpected adverse health effects associated with the product that is being evaluated, assuming that such effects exist and are detected. The attributes proposed here do not preclude the use of additional decision-specific criteria but do capture the major consequences that should be considered in any public-health-related decision.
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From page 7... ...
The very ambiguity that provides comfort makes the task of communicating and comparing uncertainties extremely difficult. The committee recommends that the uncertainty in the estimates be described as quantitatively as possible by using summary measures of a probability distribution that describes the estimate of interest.
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From page 8... ...
Third, the committee found that it was critical in each case to define the decision options to be evaluated and compared clearly so that appropriate risk information for the decision-making process could be obtained. In all cases, analytic reasoning and basic structuring tools, such as influence diagrams, were used to identify the various factors that needed to be considered to develop estimates of the public-health consequences of the alternative decision options.
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From page 9... ...
For another case study, the committee evaluated the potential public-health consequences of foodborne illness associated with three specific food categories, assuming the current regulatory and inspection regime. The three food categories selected were chosen to high light products that are inherently different with respect to level of processing, origin, and potential risks.
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From page 10... ...
When decisions must be made immediately, the committee's suggested approach can provide useful information about the public-health consequences of various options in a clear and consistent way on the basis of the best information available at the time the decision must be made. When there is ample time to evaluate and compare decision options, the suggested approach can highlight where additional information would help to differentiate between options (that is, it can help to target information collection)
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