Expert Report

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011)

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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. This report describes a risk-characterization framework that can be used by FDA to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework 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 decision-making at the FDA.

Key Messages

  • Although the committee recognizes that the FDA often must consider other factors—such as economic, social, and political factors—in addition to the public-health consequences in its decision-making, it finds that careful and consistent evaluation of the public-health consequences of various options is an essential component of good decision-making.
  • The framework offered in this report builds on the substantial amount of work that has been done on methods for estimating the human-health consequences associated with various risks, hazards, and decisions.
  • The process for using the new framework involves three steps: 1) identify and define the decision context; 2) estimate or characterize the public-health consequences of each option by using the risk attributes defined in the report; and 3) use the completed characterization as a way to compare decision options and to communicate public-health consequences within the agency, to decision-makers, and to the public, and use the comparison with other decision-relevant information to make informed decisions.
  • Risks are often characterized by a single attribute, such as the number of deaths that could occur as a result of a hazard. However, defining the risk attributes for the framework required recognition of the multidimensional nature of risk. The traditional risk-assessment paradigm gave rise to one set of attributes (exposed population, mortality, and morbidity), and the risk-ranking and risk-perception literature gave rise to a second set of attributes (personal controllability, ability to detect adverse health effects, and ability to mitigate or reduce adverse health effects).
  • The assessment, quantification, and communication of the uncertainty associated with risk-attribute estimates are essential. It is always possible to collect more data and do more analyses to try to develop "better" estimates, but there will always be uncertainty, and decisions often must be made on the basis of available information. Quantifying uncertainty—what is known and what is not known—is an important way to ensure that decisions are as well informed as possible.
  • The committee applied its risk-characterization framework to four hypothetical decision scenarios based on scenarios provided by FDA. In conducting the case-study exercises, the committee reached several conclusions: 1) it is possible to characterize different decision options by using the risk attributes and make estimates using existing data and expert judgment; 2) using the framework requires both subject matter experts and decision analysts; 3) it is critical to define the decision options to be evaluated clearly, so that appropriate risk information for the decision-making process can be obtained; 4) simply collecting more data is not necessarily the best use of resources; collecting more relevant data and organizing them so that they are useful in decision-making is the key.
  • 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), and provide a clear and consistent way to compare the options.
  • The concepts defined by the risk-characterization framework, and particularly the risk attributes defined in this report for discussing risk, will help FDA in its decision making and risk communication. Considering the outcomes of alternative decisions in terms of the attributes identified here will begin to establish consistency in risk vocabulary throughout the agency.