FDA gave the committee 16 scenarios that highlighted a variety of decisions that FDA regularly faces in which public-health consequences are relevant and for which a systematic and consistent approach for considering risk would be valuable. On the basis of the scenarios, FDA characterized the types of decisions that it faces as mitigation-selection decisions, targeting decisions, and strategic-investment decisions.
Mitigation-selection decisions are those in which FDA must weigh various alternative strategies for addressing a potential health risk. For example, how should FDA balance concerns about the safety of a product with the potential consequences of removing the product from the market?
Targeting decisions are essentially priority-setting or resource-allocation decisions and focus on how particular resources should be allocated among a broad set of products. For example, how should sparse inspection resources be allocated between seafood and fresh produce?
Strategic-investment decisions are longer-term internal decisions about where FDA should invest its resources to enable better risk-informed decision-making. For example, should FDA invest resources to improve collection of data on the food-supply chain or on medical-device surveillance?
The committee notes that there are other ways of categorizing decisions, and some decisions that are within FDA’s authority are difficult to fit within the three categories defined here. However, for purposes of developing a decision-focused risk-characterization framework for FDA, the committee adopted FDA’s categorization of decisions.
Health consequences are a subset of the larger array of factors that must be considered for any given problem. Because such factors loom large in most FDA decisions, they constitute a reasonable place to start the process of developing a decision framework. The framework offered here 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. 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.
The process is straightforward and involves three steps: