Abstract
This article develops a theoretical framework to analyze the variability in Food and Drug Administration (FDA) approval decisions among competing industries, specifically those that produce new brand-name drugs, generic drugs, and medical devices. The theory provides a framework to test empirically for the determinants of FDA approval decisions. These determinants include the agency's budget, congressional preferences, and several proxies for industry interests and consumer interests. Results from the analysis suggest that the agency's response to these determinants varies among the three different industries' approval activities. The patter of variation implies that bureaucratic discretion is highest for the products with the greatest regulatory stringency. This variation in agency responsiveness further suggests that no single theory of regulation can explain the agency's approval decisions among the three industries. Instead, different theories of regulation-such as public interest, capture, or congressional control-are needed to explain different industry approval activities.
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