The will of #Congress? Permissive #regulation and the #strategic use of #labeling for the anti- #influenza #drug #Relenza (Soc Stud Sci., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Soc Stud Sci. 2019 Nov 19:306312719890015. doi: 10.1177/0306312719890015. [Epub ahead of print]

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

Mulinari S1, Davis C2.

Author information: 1 Department of Sociology, Lund University, Lund, Sweden. 2 Department of Global Health and Social Medicine, King’s College London, UK.

 

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.

KEYWORDS: Food and Drug Administration; corporate bias; influenza; pharmaceutical industry; regulation; regulatory capture

PMID: 31739775 DOI: 10.1177/0306312719890015

Keywords: Society; Politics; Public Health; USA.

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Giuseppe Michieli

I am an Italian blogger, active since 2005 with main focus on emerging infectious diseases such as avian influenza, SARS, antibiotics resistance, and many other global Health issues. Other fields of interest are: climate change, global warming, geological and biological sciences. My activity consists mainly in collection and analysis of news, public services updates, confronting sources and making decision about what are the 'signals' of an impending crisis (an outbreak, for example). When a signal is detected, I follow traces during the entire course of an event. I started in 2005 my blog ''A TIME'S MEMORY'', now with more than 40,000 posts and 3 millions of web interactions. Subsequently I added an Italian Language blog, then discontinued because of very low traffic and interest. I contributed for seven years to a public forum (FluTrackers.com) in the midst of the Ebola epidemic in West Africa in 2014, I left the site to continue alone my data tracking job.