This dissertation develop methods for evaluating communications, using the criterion of informed consent, in the sense that communications should help consumers identify choices in their best interest. It leads to a prescriptive approach to regulatory decision making, regarding the adequacy, of such communications. It combines risk and decision analysis and behavioral decision research, integrating scientific knowledge regarding the risks, including the attendant uncertainties, and user behavior, including the heterogeneity in their values, beliefs, and decision-making competence. This approach is designed to accommodate diverse regulatory philosophies, regarding both regulators' concern for consumers' welfare and their assignment of responsibility of imperfections in consumer decision making. The result is a suite of regulatory options, showing the impact each option has on producer decision making and ultimately consumer welfare.; Chapter 1 develops the theoretic framework for determining an acceptance region of communication failure that incorporates the regulator's acceptable trade-offs between benefits and judgment or decision errors, as a function of a product (with its risk and benefits), a consumer population (heterogeneous in its response to product risks and informational needs) and a communications (its content and form). Chapter 2 demonstrates the approach with two case studies, one for saw palmetto, a dietary supplement marketed to men, and the second for over-the-counter cholesterol-lowering statin. Each case study identifies choices in consumers' best interests, by making optimal usage of the best-available information. The approach proceeds to descriptive assessment of how well consumers will fare in identifying those personally optimal choices---considering the sensitivity of the choices to imperfect communications (realistic product labels) and imperfections in lay inferential processes. Adapting the mental models approach to risk communication, we empirically test actual product communications on a sample of the population making these choices, focusing our efforts on the issues highlighted in the best-interest analyses. Chapter 3 analyzes the framework from the perspective of manufacturers, developing a general model for estimating the impacts of FDA's actions on producers' decision making, which can accommodate the regulatory, market and liability uncertainty in the producer's decision context. Chapter 4 considers the strategic choices facing regulators, in the light of the impacts of potential policies on information users and providers.
展开▼
