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.

International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency

“…Unlike in some countries with public regulation, the ABPI and JPMA did not cover payments related to over-the-counter medicines [ 21 ], medical devices, or veterinary products [ 24 , 36 ]. Also excluded from disclosure were organisations targeted by the industry’s lobbying [ 32 , 103 , 154 – 156 ], which are sometimes covered by public regulation, such as the Ministry of Health (Portugal) [ 157 ] and media organisations (France) [ 158 ].…”

Divergent spender: State‐societal and meso‐organisational mechanisms in the containment of public spending on pharmaceuticals in a liberal capitalist democracy

“…This echoes Carpenter's view (2001) that ‘bureaucratic autonomy’ can set representative opinion. Thus, rather than neo‐liberal political will (Mulinari & Davis, 2020) or consumerist individualism shaping regulatory culture (Daemmrich, 2004; Davis & Abraham, 2013: chapter 2), the regulators’ appeal to public‐political concepts, such as utility, fairness and economic security. NLCB theorists may additionally claim that containment does not require the support of instrumental mechanisms––for example, widespread conflict of interests, policy access––and is initiated endogenously by bureaucrats on behalf of the capitalist class.…”

“…We identified two crucial themes namely, (1) the institutional mechanisms behind the spending policy outcomes, and (2) the consistency of these outcomes with the interests of the state or the interests of the pharmaceutical sector. To consider them, we compared the respective explanatory power of contrasting theories of the western state (Historical Institutionalism and Corporate Domination Theory) and, partially competing (Mulinari & Davis, 2020), theories of pharmaceutical policymaking (Corporate Bias Theory and Reputational Theory).…”

“…Reputational Theory can align with NLCB. For example, agency acquiescence to industry's regulatory demands may be a self‐interested attempt to maintain agency reputation, and equally predicted by ‘corporate bias’ (Mulinari & Davis, 2020). Nevertheless, Reputational Theory has been primarily associated with industry‐independent bureaucracy and a theorisation of agency power over the pharmaceutical marketplace (Carpenter, 2010).…”

“…Specifically, neo‐liberal ideology––especially a deregulatory logic––in higher level spheres of governance has been linked to alterations in regulatory organisations’ structures, personnel and decision‐making (Davis & Abraham, 2013; Lexchin, 2016). Nevertheless, regulatory agencies may also initiate policy shifts more endogenously, responding to wider public‐political culture (Mulinari & Davis, 2020).…”