Policy Tragedy and the Emergence of Regulation

The Food, Drug, and Cosmetic Act of 1938

This article reviews some historical elements of policy formulation, and questions the received wisdom among scholars of the history of government regulation that regulations arise from crises, tragedies and scandals. The authors examine one of the most important regulatory statutes in the United States, and even worldwide—the passing of the Food, Drug, and Cosmetic Act of 1938. This act gives the U.S. Food and Drug Administration (FDA) sole authority over whether any pharmaceutical product can be sold.

Traditional explanations of the passing of the 1938 law ascribe the event to a combination of New Deal policies, and a drug scandal in which a sulfonamide drug resulted in 107 deaths. This latter event is part of the traditional “policy tragedy” explanation for the passing of the FDA act. The authors examine this policy tragedy explanation in detail, pointing out that it oversimplifies the historical context in which the 1938 act came into being. For example, “the sulfanilamide tragedy occurred when the Senate and House were already well informed about alternative regulatory measures facing them…. Had the sulfanilamide tragedy occurred at another time…the Act would either not have passed or would have taken a much different form,” the authors write.

Another tenet central to the authors’ discussion of the nuances of policy tragedies is that tragedies must be reframed in order to serve as driving forces for regulatory action. In this case, certain elements of the drug scandal were focused upon as part of the events’ packaging. For example, the deaths that were highlighted were of white children, despite the fact that the majority of deaths had occurred among black male adults, many of whom were seeking treatment for syphilis. Lastly, the authors point out that in this case, “it is worth remembering that a government agency, one well equipped to reveal and interpret the sulfanilamide affair, acted as the narrator of record in this story. In the act of framing, privileged access to the facts that are being distilled can generate greater authority and credibility of the interpretation produced.”