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Failure of responsive regulation? : Pharmaceutical marketing, corporate impression management and off-label promotion of enzalutamide in Europe

Mulinari, Shai LU ; Davis, Courtney and Ozieranski, Piotr (2021) In Journal of White Collar and Corporate Crime 2(2). p.69-80
Abstract
“Responsive regulation” has been proposed to offset pharmaceutical industry illicit behaviour in areas such as drug marketing based on self- regulation backed up with threats of government sanctions. We explore the efficacy of responsive regulation by tracing recent investigations by the UK pharmaceutical industry self-regulatory authority into the firm Astellas’s illicit promotion of a top-selling prostate cancer drug. Using documentary data, we reveal a ruthless company culture reflected in the illicit, so-called off-label promotion across Europe and the deceptive “impression management” by company managers during the course of investigations in the UK. We argue for a more probing, adversarial and government-led regulatory approach... (More)
“Responsive regulation” has been proposed to offset pharmaceutical industry illicit behaviour in areas such as drug marketing based on self- regulation backed up with threats of government sanctions. We explore the efficacy of responsive regulation by tracing recent investigations by the UK pharmaceutical industry self-regulatory authority into the firm Astellas’s illicit promotion of a top-selling prostate cancer drug. Using documentary data, we reveal a ruthless company culture reflected in the illicit, so-called off-label promotion across Europe and the deceptive “impression management” by company managers during the course of investigations in the UK. We argue for a more probing, adversarial and government-led regulatory approach instead of the self-regulatory approach that shields breaching companies from enforcement actions and associated public scrutiny. (Less)
Please use this url to cite or link to this publication:
author
; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
pharmaceutical industry, responsive regulation, self-regulation, corporate crime, off-label, marketing
in
Journal of White Collar and Corporate Crime
volume
2
issue
2
pages
69 - 80
publisher
SAGE Publications
external identifiers
  • scopus:85214667066
ISSN
2631-309X
DOI
10.1177/2631309X20970477
project
What can be learnt from the new pharmaceutical industry payment disclosures? A network and policy analysis of ties between companies and health professionals and organisations
language
English
LU publication?
yes
id
ed9a3e68-1bf5-4bbb-bc15-63e35368e966
date added to LUP
2020-09-16 08:04:24
date last changed
2025-03-16 04:02:07
@article{ed9a3e68-1bf5-4bbb-bc15-63e35368e966,
  abstract     = {{“Responsive regulation” has been proposed to offset pharmaceutical industry illicit behaviour in areas such as drug marketing based on self- regulation backed up with threats of government sanctions. We explore the efficacy of responsive regulation by tracing recent investigations by the UK pharmaceutical industry self-regulatory authority into the firm Astellas’s illicit promotion of a top-selling prostate cancer drug. Using documentary data, we reveal a ruthless company culture reflected in the illicit, so-called off-label promotion across Europe and the deceptive “impression management” by company managers during the course of investigations in the UK. We argue for a more probing, adversarial and government-led regulatory approach instead of the self-regulatory approach that shields breaching companies from enforcement actions and associated public scrutiny.}},
  author       = {{Mulinari, Shai and Davis, Courtney and Ozieranski, Piotr}},
  issn         = {{2631-309X}},
  keywords     = {{pharmaceutical industry; responsive regulation; self-regulation; corporate crime; off-label; marketing}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{2}},
  pages        = {{69--80}},
  publisher    = {{SAGE Publications}},
  series       = {{Journal of White Collar and Corporate Crime}},
  title        = {{Failure of responsive regulation? : Pharmaceutical marketing, corporate impression management and off-label promotion of enzalutamide in Europe}},
  url          = {{https://lup.lub.lu.se/search/files/86409319/Mulinari_etal_JWCC.pdf}},
  doi          = {{10.1177/2631309X20970477}},
  volume       = {{2}},
  year         = {{2021}},
}