The Authority of Doubt Regulatory Culture, Knowledge, and the Re-Making of Pharmaceutical Governance after Thalidomide

The thalidomide disaster (1957–1962) is often narrated as a biomedical tragedy caused by inadequate testing. This paper argues that its deeper historical significance lies in how it transformed the epistemic and moral foundations of pharmaceutical governance. The decisive variable separating catastrophe from containment was not superior scientific knowledge, but regulatory culture—specifically, whether institutions treated uncertainty as tolerable risk or as grounds for restraint. In the United States, FDA medical officer Frances Oldham Kelsey withheld approval for thalidomide amid incomplete evidence, legitimizing delay as a protective act. In contrast, West Germany and much of Europe operated within trust-based regulatory systems that normalized limited premarket proof and dispersed responsibility across manufacturers, physicians, and courts. By integrating institutional history, comparative regulatory analysis, and regulatory theory, this paper reconstructs how doubt became a form of state authority, how that authority was codified in the 1962 Kefauver–Harris Amendments, and why this transformation remains central to contemporary debates over accelerated approvals, emergency authorizations, and public trust.¹Methodologically, the article employs comparative historical analysis across the United States and West Germany, drawing on statutory texts, FDA institutional materials, parliamentary records, and contemporaneous medical literature to explain why similar scientific uncertainty produced divergent regulatory outcomes.