The history of generic drugs is far from generic

Guest post by Jeremy A. Greene

I entered medical school during a strange interlude in the history of drug marketing. Perhaps you also remember those confusing months in 1997, after the FDA issued statements supporting widespread direct-to-consumer promotion of prescription drugs, but before the regulation of these ads had been fully worked out. Pharmaceutical brand names were suddenly everywhere—on billboards, at football games, on the radio, on the television—but their presence felt both new and uncertain. Here one found cabalistic, inscrutable ads for something called “Claritin” with no explanation of what is was or what it did; there one found ads praising a new but unnamed breakthrough drug that promised to liberate hundreds of thousands of allergy sufferers from their daily burdens. Other advertisements tinkered with the FDA’s principle of “fair balance,” countering every minute spent extolling the virtues of a drug with 60 seconds of rapidly recited side effects, from somnambulism to prolonged erections. By now we have learned to think of these catechisms of ailments as a regular and recurring backdrop to evening television programs, but right then, at the beginning of my medical training, they stood out as jarring reminders of the outsized role that pharmaceutical marketing played in shaping how doctors and patients think about their bodies in health and in disease.

Like many medical students skeptical of the influence of Big Pharma, I developed a preference for “little pharma,” learning to prescribe generic names and generic drugs wherever possible.  I came to see the brand name as a veneer of marketing plastered awkwardly over an underlying chemical which could be better known by its generic name. That inner, generic drug was the true drug: it possessed efficacy, safety, pharmacokinetics, pharmacodynamics, all the things one needed to practice medicine. By contrast, the superficial, brand name drug represented everything commercial about biomedicine: advertising budgets, market share, return on investment. The difference between brand and generic seemed to recapitulate Marx’s distinction between use-value and exchange value: if the brand-name symbolized all that was wasteful in commodified, profit-driven healthcare, the generic drug represented medicine at its most useful, affordable, and accessible.

But as I studied the history of the pharmaceutical industry in more detail, this interpretation was interrupted by a series of stories that stubbornly refused to conform to these dichotomies. In the archives of the FDA, I found reams of inspections of early generic drug companies in the 1960s and 1970s documenting gross violations of manufacturing practices, as well as cases in which the generic drug had been substantially inferior to the original brand name product. Decades later, in thousands of pages of Congressional hearings, I found testimonies and documentary evidence depicting the Generic Drug Division of the FDA as a weak bureaucracy riddled with graft and bribery which had approved generic products on the basis of fraudulent data. On the one hand, therapeutically equivalent generic drugs had clearly played an important role in improving access to care in the American health system.  On the other hand, the generic drug industry was clearly not a benign outgrowth of the U.S. Public Health Service but an industry in its own right, no more and no less susceptible to collusion or graft than the brand-name drug industry. And by the end of the century, with roughly 80% of American prescriptions being filled generically, it could not really properly be called “little pharma” any more, either.

These materials suggested that the generic drug was not a timeless ideal but a dynamic and historically contingent object that emerged at the intersection of key economic and political fault lines in the business and practice of American medicine. Studying the origins and evolution of the generic drug gave me a chance to examine the broader problems of similarity and difference in modern biomedicine: What forms of science, and what kinds of politics, were involved in declaring two drugs to be the same, or at least the same in all ways that matter? Who decided when a medicine was good enough to be substituted for another? How and when and where did these sciences of similarity emerge? The research that led to Generic: The Unbranding of Modern Medicine took me through thousands of letters to and from the FDA, stacks of Congressional hearings, scores of personal and institutional archives, and hundreds of debates that raced through the pages of popular, scientific, clinical, policy, and industry journals.

The story that emerged was far from generic. The availability of cheap, safe, equivalent therapeutics is crucial to the practice of medicine today: as a patient and a physician, I can’t go a week without using generic drugs in some form. Yet their emergence has been both recent and rocky. If it is important for consumers  to understand the outsized role of the pharmaceutical brand name in modern health care, it is just as important to understand the structures that lead to their unbranding.

To listen to Science Friday’s interview with Jeremy Greene, click here.

greeneJeremy A. Greene, MD, PhD, is an associate professor of medicine and the history of medicine and the Elizabeth Treide and A. McGehee Harvey Chair in the History of Medicine at the Johns Hopkins University School of Medicine. He is the author of Generic: The Unbranding of Modern Medicine and Prescribing by Numbers: Drugs and the Definition of Disease and the coeditor of Prescribed: Writing, Filling, Using, and Abusing the Prescription in Modern America, all published by Johns Hopkins.