The will of Congress? Permissive regulation and the strategic use of labeling for the anti-influenza drug Relenza

Abstract

Through an analysis of the FDA’s approval of the controversial anti-influenza drug Relenza (zanamivir), we interrogate distinct social scientific theories of pharmaceutical regulation. We investigate why, despite internal negative opinions and an Advisory Committee’s non-approval recommendation, the FDA approved Relenza in the late 1990s. Based on a close reading of FDA documents, we show how agency officials guided the manufacturer’s analyses and participated in constructing a tenuous argument for approval. We show how regulators may strategically design drug labels that can justify their permissive regulation. We consider the explanatory power of official accounts and alternative, partially overlapping, theories of pharmaceutical regulation in the Relenza case, and develop new insights into the institutional dynamics of regulator-industry relations. We find little or no evidence that the FDA was primarily driven by public health concerns, pressure from disease-based patient activism, or a consumerist and neoliberal regulatory logic, although some of these explanations provided managers with convenient rhetoric to rationalize their actions. Rather, we argue that the Relenza case highlights contradictions between a scientific culture at FDA, conducive to rigorous product evaluations, and the agency’s attempts to accommodate higher-level political (i.e. Congress) and industry demands conducive of permissive regulation – consistent with some aspects of reputational and capture theories, as well as with corporate bias theory.