Generic pharmaceuticals are considered biochemical copies of brand-name drugs and have become an important component of contemporary scientific innovation and policy. As the market for generic substitutes has grown--from only 10% of the American pharmaceutical market in 1960 to nearly 80% by 2010--so too have technical and political conflicts over whether generics are truly "the same thing" as their brand-name counterparts. Indeed, generic drugs are never fully identical to their original counterparts; rather, their identity as generic resides in being similar in the particular ways that regulators and scientists think matter.
This Scholar's Award, funded by the STS program and the Directorate for Mathematical and Physical Sciences, will support Jeremy Greene, a physician-historian with ethnographic training, as he tracks the emergence of scientific and policy definitions of biochemical equivalence in the late 20th century and early 21st century. Using archival data, analysis of scientific publications, and in-depth interviews, Greene will trace how the question: "when are two medicines the same?" generates different answers depending on the method and discipline from which it is asked. For example, people (at different times and in different countries) have used innovations in chemistry, biology, engineering, and management science to either argue for or contest the similarity of generic pharmaceuticals.
This research will contribute to social scientific studies of science policy and regulation as well as the history of science and innovation. A close examination of how generics are defined over time and across countries reveals how different stakeholders promote and contest various ways of defining biochemical equivalence. Grappling with the problems of equivalence and interchangeability also demonstrates how specialization shapes the generalizability of scientific knowledge and the cultural and scientific assumptions that help produce science policy.
