Fast track: The practice of drug development and regulatory innovation in the late Twentieth Century U.S

Abstract

This thesis examines the laws and regulations created in the 1980s and 1990s in the U.S. to hasten development, evaluation, and approval of drugs to treat serious and lifethreatening diseases, and to allow access of seriously ill patients to investigational drugs on a pre-market approval basis. Using detailed historical exposition in tandem with the social-theoretic tools of the sociology of scientific knowledge (SSK), and particularly Barnes’s account of meaning finitism, this thesis examines the social origin, definition, and case-by-case application of conceptual categories in the regulatory oversight of drug development and approval. With this approach, rules and standards for drug approval are shown not to be fossilised machinery for decision-making, but rather living, socially produced and maintained, inherently revisable resources for action. Key conclusions from this study are that: the regulatory actions taken to confront AIDS in the 1980s, often considered to be a radical break with previous practice, had their conceptual origins in the 1960s and 1970s; rule-making is often constitutionally related to a creative process of rule-‘breaking’; tacit processes of consensus outside of, and prior to, formal consensus mechanisms for rule-making are often fundamental to the rule-making process, resulting in de facto ‘rules’ on which later, formal rule-writing can be based; as predicted by finitism, newly created categories of action in drug development and approval require reinterpretation of underlying concepts in related existing categories. The thesis also demonstrates the flexibility and revisable nature of existing conceptual resources for application to current circumstances, consistent with a finitist view of knowledge. While the conclusions of this research are based on only one area of regulation, they are suggestive for more general descriptions of regulatory action. Contemporary theories of regulation are typically designed as economic models or are viewed through traditional categories of law and political science. As a result, they tend to abstract reality, ignoring day-to-day administrative practice, idealizing the nature of rule-following and rulemaking, and ignoring tacit processes of consensus. This thesis brings an interdisciplinary perspective to the theory of regulation, suggesting the outlines of a ‘social’ theory of regulation more fully sensitive to the empirical reality of the social process of rule-making and rule-breaking in contemporary regulation.