Abstract: Voluntary Compliance as Regulatory Policy: Inside the Food and Drug Administration in 1981-1982

Lucas Richert


The Reagan administration's plan to limit the size and scope of government, reduce excessive regulation, and promote increased cooperation between businesses and U.S. regulatory agencies had far-reaching effects. This article investigates and evaluates the relationship between the pharmaceutical industry and the U.S. Food and Drug Administration in 1981 and 1982. I argue that the implementation of a voluntary compliance policy, coupled with substantial resource cuts, marked a significant transformation at the FDA, and this policy in turn produced varied results that lent weight to both its critics and its supporters. The case of Oraflex demonstrated the dangers of over-reliance on business and industry to align its interests with the American public and the FDA. Yet, the revoking of rules providing for patient package inserts proved that cooperation between the FDA and business was a reasonable pretext to roll back existing regulations. Voluntary compliance signaled a stark shift in regulatory policy at the FDA, and this article aims to furnish an understanding of how this policy was established and what it meant for the future of FDA drug regulation.