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

Mulinari, Shai LU and Davis, Courtney (2020) In Social Studies of Science 50(1). p.145-169
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
corporate bias, Food and Drug Administration, influenza, pharmaceutical industry, regulation, regulatory capture
in
Social Studies of Science
volume
50
issue
1
pages
145 - 169
publisher
SAGE Publications
external identifiers
  • scopus:85075377476
DOI
10.1177/0306312719890015
project
The dilemma of the swine flu vaccine
language
English
LU publication?
yes
id
7af427a3-15da-4a46-91ed-88d7a1899754
date added to LUP
2019-09-26 15:51:27
date last changed
2020-01-23 09:43:38
@article{7af427a3-15da-4a46-91ed-88d7a1899754,
  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.},
  author       = {Mulinari, Shai and Davis, Courtney},
  language     = {eng},
  month        = {01},
  number       = {1},
  pages        = {145--169},
  publisher    = {SAGE Publications},
  series       = {Social Studies of Science},
  title        = {The will of Congress? Permissive regulation and the strategic use of labeling for the anti-influenza drug Relenza},
  url          = {https://lup.lub.lu.se/search/ws/files/71998041/Mulinari_Davis.pdf},
  doi          = {10.1177/0306312719890015},
  volume       = {50},
  year         = {2020},
}