The framework offered here 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. This chapter first provides a brief description of the proposed framework and the risk and decision contexts that influenced the committee’s approach. Next, the basis and definition of the risk attributes that characterize the framework are provided, and then some approaches for estimating the outcomes of decisions using the risk attributes are described. The chapter concludes with a discussion of how the output of the framework can be used to support decision-making.

THE FRAMEWORK

The risk-characterization framework is designed to be as general as possible while providing consistent risk information in a way that can be used to support the wide variety of decisions that FDA faces. It is intended to supplement and augment other risk-based and risk-informed approaches that are in use and under development by FDA, not to be a replacement or a one-size-fits-all prescription for conducting all risk-informed decision-making. Indeed, the committee recognizes that the public-health-consequence factors highlighted in this framework will seldom be the only important considerations in the decision-making process, but they are almost always some of the key considerations. The U.S. Nuclear Regulatory Commission has also recognized that risks are not the only factors that must be taken into account in regulatory decision-making. It recently embraced the concept of risk-informed decision-making, which it defines as “the use of risk insights, along with other important information, to help in making decisions” (USNRC 2008, page 1-1). The committee’s framework focuses on risk information but also recognizes that other information will be relevant for most FDA decisions.

The process is straightforward and involves three steps:


Step 1. Identify and define the decision context: What decision options are being considered? What are the appropriate end points to evaluate and compare?

Step 2. Estimate or characterize the public-health consequences of each option by using the risk attributes that are described below. The values of the risk attributes should be summarized in a table to facilitate comparison of the options.

Step 3. Use the completed characterization as a way to compare decision options and to communicate their public-health consequences within the agency, to decision-makers, and to the public; use the comparison with other decision-relevant information to make informed decisions.


Although the steps can be easily articulated, they involve thought and effort to complete. The framework is not a cookbook and will require FDA to ex-



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