Pharmaceutical Manufacturing in America: a Brief History

Pharmaceutical Manufacturing in America: A Brief History by Arthur Daemmrich* Abstract: This article reviews the history of drug manufacturing and changes in the compounding of drugs by pharmacies in the United States and outlines opportunities for new research into the making of medicines. The pharmaceutical industry has long been on the vanguard of globalization, and drug companies restructured their international manufacturing footprints frequently in the 19th and 20th centuries. Firms in the prescription drug sector were among the first to market products internationally, to build manufacturing plants around the world, and to integrate research from laboratories across multiple time zones. Yet, issues of quality and safety have arisen repeatedly and the industry has continued to pro- duce its newest medicines in North America even as technological capabilities increased significantly in China, India, and elsewhere since the 1980s. Compounding pharmacies, by contrast, experienced a steady decline during the second half of the 20th century as medicines arrived from producers in final form. The emergence of individualized therapies, however, is now bringing a resurgence in business for biological labs acting in many ways as compounders. Broadly, as pharmaceutical firms turned to a business model built around research and intellectual property production, and as pharmacists shifted from producing medicines to repackaging them for patients, analysts likewise turned to regulation, pricing, and new product innovation as subjects of their research. As a consequence, pharmaceutical manufacturing is largely ignored in the recent historiography of medicine, pharmacy, and pharmaceuticals, an oversight that should be rectified. Introduction countries, while biotech-based medicines were produced in the United States and Europe. Pharmaceutical firms known today for their In the meantime, the majority of pharma- new drug innovation and worldwide marketing cies experienced a sharp decline in the need for largely grew out of nineteenth-century pharma- drug compounding even as they grew into national cies and chemical manufacturers. On the leading chains between the 1950s and early 2000s. The re- edge of globalization, these companies expanded cent emergence of personalized medicine, typically production around the world between the 1890s involving treatments customized based on a pa- and 1910s, rebuilt in the interwar period, and then tient’s specific cancer or immunological disorder, grew internationally again after World War II. By is sparking new demand for the services of com- the 1990s, manufacturing was highly specialized pounding pharmacies and biotechnology laborato- and involved complex production chains that of- ries. Furthermore, a new wave of concern regard- ten spanned multiple countries. Small molecule ing product quality and counterfeit drugs suggests chemicals, including both generics and active in- that writing an obituary for drug manufacturing in gredients for branded drugs, were typically made the United States is premature. in facilities in China, India, or other developing Published in 1965, Glenn Sonnedecker’s “The Rise of Drug Manufacture in America” of- * Director, Lemelson Center for the Study of Invention and In- novation, Smithsonian Institution, Washington, D.C., email: fers an intriguing snapshot against which to [email protected]. consider subsequent changes to pharmacies Vol. 59 (2017) No. 3 www.aihp.org 63 and the pharmaceutical industry.1 In the article, drawn instead to the arenas of medicinal inno- Sonnedecker captured the sector’s history from vation, human clinical trials, and marketing.7 nineteenth-century apothecary to a modern in- This article begins with an overview of dustry, with manufacturing at the center of its Sonnedecker’s 1965 work and then brings the identity. Written just three years after the major history up to the present by outlining changes regulatory intervention of the 1962 Kefauver- in the manufacture of drugs in America. I find Harris Drug Amendments, Sonnedecker’s es- that the pharmaceutical industry offers a key lo- say in retrospect marked the end of an era for cus for issues of interest to historians of science, compounding pharmacies and the beginning of technology, and medicine as well as to contem- a shift in the industry away from its manufactur- porary policy analysts regarding manufacturing roots. While firms had established research ing more generally. The article concludes with laboratories starting in the early 1900s (and thoughts concerning ongoing tensions in the on- had chemistry labs to test compounds and oc- tological status of the pharmaceutical industry, casionally synthesize new ones some decades an important issue raised somewhat cryptically before), they retained strong manufacturing at the end of Sonnedecker’s article. identities through the 1950s.2 Similarly, while chain pharmacies enjoyed tremendous growth after WWII thanks to sales of prescription drugs Origins and Growth of pre-supplied in pill or tablet form, compounding of medicines remained at the core of their busi- American Drug Manufacturing ness when Sonnedecker wrote his article.3 Both Sonnedecker begins his review with an would change significantly after the mid-1960s.4 intriguing observation concerning both individ- Taking Sonnedecker’s essay as a point of ual and collective (i.e., public health) reliance departure, this article advances a long-range on a “remote industrial complex” that produced history to the pharmaceutical industry’s manu- drugs and medical supplies.8 Treatments that facturing function, with attention also to shifts were historically manufactured or compounded in pharmacies as sites for compounding drugs. locally by a physician or pharmacist were pro- While critical of linear path innovation narra- duced and packaged at a distance by the mid- tives, most recent scholarship nevertheless gives 1960s. Sonnedecker suggests that discomfort dominance to the laboratory and clinic while with this distance was greater than for other underplaying manufacturing. The production of industries; thus even though food was bought medicines is not seen as a place of change over packaged from stores in the 1960s, consumers time or of strategic significance to the industry. maintained some proximity to farms and could Furthermore, few studies connect pharmacy and see the original source of what they were buy- pharmaceuticals as historians like Sonnedecker ing. The claim is an intriguing one; Americans and others had done for decades.5 had bought medicines from Europe and Asia Instead, historians and economists are since colonial times and national marketing examining success or failure with drug dis- of both patent drugs and legitimate medicines covery, clinical trials, marketing, and merg- had separated consumers from the animal, ers to explain the longevity or brevity of indi- plant, or mineral origins of therapeutics since vidual firms.6 For the pharmaceutical industry at least the 1880s. But Sonnedecker was correct writ large, scholars are tracking the industry’s to observe that further distancing patients from strategic shifts when examining knowledge where the ingredients in their prescription production, information management, and medicines were sourced, and who had com- advertising and marketing. As a result, manu- pounded them, was impacting public trust. facturing has been ignored as a potential con- From the early colonial period through tributor to innovation or as a source of com- the mid-nineteenth century, limited medical petitive advantage. Even though the business supplies and the vagaries of shipping constrict- of pharmaceutical firms has been aptly char- ed American pharmacy. Native therapies were acterized as “the manufacture and processing adopted and adapted into folk treatments and of raw materials into medicines,” historians of Americans living and working on large farms in science, technology, and medicine have been the south or on the frontier often had a medi- 64 www.aihp.org Pharmacy in History cine chest with powdered and dried materi- seeking to understand both treatment practices als that they mixed themselves using recipes and changes over time to therapeutics, reveal provided with the kit. A variety of texts sup- a rough balance among botanical medicines, ported home remedies, ranging from practical chemical drugs, and preparations ready to use folk narrative to exotic suggestions. For urban (tinctures and plasters). Superstitious remedies residents, apothecaries grew up in the heart of found in sixteenth-century and seventeenth- cities like Boston, New York, and Philadelphia. century medicine kits were no longer common Some, for example, Smith, Kline & French in by the 1770s. However, concerns about varia- Philadelphia, later grew from small communi- tion in kits, worries about the compounding of ty pharmacies into manufacturers of pills and drugs on the American frontier, and the desire then began doing research into new medicines of pharmacists and the nascent pharmaceutical in the early twentieth century. industry to demonstrate independence from Eu- The Revolutionary War impacted drug rope spurred the development of the first United imports for several years and stimulated do- States Pharmacopeia, published in 1820.9 mestic production in larger pharmacies. The Yet, while some pharmacies turned into Continental Congress even set up a manufac- manufacturing laboratories and later into mul- turing laboratory under an Apothecary General. tinational

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