Generic: The Unbranding of Modern Medicine by Jeremy A. Greene
By Jeremy A. Greene. Baltimore: Johns Hopkins University Press, 2014. Pp. 354. Paperback $29.95.
What is a prescription drug? It is, of course, a pill, injection, or infusion that we take to cure or treat disease. It also is a technology, created by humans and intertwined with innovation systems, regulatory policy, and marketing. Yet most histories of pharmaceuticals either have focused on medical aspects (quality, safety, and efficacy); political dimensions (debates over marketing, pricing, and insurance); or anthropological perspectives (human stories of discovery, testing, and use) of pharmaceuticals. Jeremy Greene's thoroughly researched and insightful analysis of generic drugs helpfully crosses boundaries between these types of histories while raising, but not resolving, intriguing questions about [End Page 1129] how to think about generic technologies more generally.
Generic and branded pharmaceuticals have intertwined histories. Price competition in American pharmacies emerged in the early nineteenth century as patent medicine shops challenged imports from established European manufacturers. From the late nineteenth century through the midtwentieth, the "ethical" industry emphasized seals of quality and brand names to differentiate itself from generic and "patent" drug makers. In the post-WWII period, pharmaceutical firms increasingly used trademarked brand names for drugs and marketed them heavily to physicians.
When Senator Kefauver sought to reform the pharmaceutical market in the early 1960s, he proposed mandating prescribing by chemical rather than brand name. The legislative effort to de-brand the American drug market failed, and its rewrite to focus on safety and efficacy led the industry to even further emphasize brand names. By the 1990s and 2000s, generics were repeatedly held up as a solution to drug costs, and policy shifts increased the right of pharmacists and insurers to substitute generics for branded medicines. Yet as Greene documents, generic drugs have not bent the cost curve for prescriptions even as their overall use increases.
Greene proceeds in six parts, balancing a chronological history with specific topics that arise repeatedly over time. Part one tracks the history of drug names and the institutions that have sought to require, promote, or prevent standardized generic naming. Part two looks at the growth of generic manufacturers in the 1960s and 1970s as they responded to rising prices for branded drugs and demand for alternatives from private insurance and state and federal programs. Part three covers bioequivalence, showing that seemingly technical disputes over terminology and testing were deeply intertwined with political and economic choices. Part four covers a forty-year history of state anti-substitution laws, with a gradual rise of generics as states repealed restrictions on pharmacists. Part five explores tensions in expertise and authority between patients and physicians related to different sources of information about medicines. Finally, part six considers issues arising from international trade in medicines, both generic and branded, and the emergent role of pharmacy benefits managers, a controversial additional middleman in the medicines sector.
Beyond medical history and pharmaceutical policy, what does the book tell us about generic technologies? I offer two short examples of how historians of technology and business historians can draw upon Generic. First, generics raise interesting questions regarding information asymmetries. The purchaser (an ill patient) is not in a position to know whether the pill they are taking will work the same as the branded drug. Regulators can declare two compounds equivalent, but with global supply chains and variation in body biochemistry, equivalence may not equate to equal efficacy. [End Page 1130] This is intriguing to compare to other sectors. Car companies, for example, worry about generic parts, not just for their competition with a profitable business, but because automakers fear they will still be blamed in the case of accidents. Relative to their impact on markets ranging from clothing to car parts to medicines, generic products are poorly studied and often weakly regulated.
Second, the alternating love / hate relationship of Americans to brands deserves greater study and critical engagement. At key points in the past 150 years, people have sought out and paid premiums for visibly branded clothing, cosmetics, luggage, and so on. However, at other points in time, including among a present generation less eager to wear shirts printed with large corporate names, brand names get less visible. Mapping and relating these shifts over time and between different sectors would be ambitious, but also very revealing of the complex relationships between corporations and consumers over time.
Overall, this book has already found a strong audience among medical historians and pharmaceutical policy analysts; it would make an intriguing read also for students in courses exploring the history of technology, marketing, and American business. [End Page 1131]
Arthur Daemmrich is director of the Lemelson Center for the Study of Invention and Innovation at the Smithsonian Institution. He has published on the history of pharmaceutical regulation and healthcare systems.