At the close of the nineteenth century, the pharmaceutical industry bore little resemblance to the industry we know today, except for the widespread public concern for the safety of compounds sold for treatment and prevention of disease. Much of this concern stemmed from unacceptable marketing practices of “snake-oil salesmen” hawking their goods to a hopeful but uninformed populace, with false claims of efficacy for untested products, many of which were devoid of benefit and actually harmful to human health. Tragedy and public outcry led to legislative action, ultimately taking form as the Food, Drug and Cosmetic Act, the law that forever changed the industry by establishing a regulated approach to testing and marketing of pharmaceutical products in the United States under the Food and Drug Administration (FDA).

The thalidomide tragedy of the late 1960s resulted in major reform of the FDA, requiring that all products be thoroughly tested for both safety and efficacy before they could be approved for marketing. Over the years, FDA regulations have become ever more detailed, complex, and invasive, to the point that today, many in the industry, as well as scientists, government, and even patient advocacy groups, complain that this onerous regulatory burden has stymied the introduction of new products to the detriment of the industry, medical progress and human health. William Weldon reflects this view in Chapter 16, “A Future Agenda for Government–Industry Relations.