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
