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

Summary, in English

“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: Shai Mulinari; Courtney Davis; Piotr Ozieranski
• Department/s: Sociology
• Publishing year: 2021-05-06
• Language: English
• Pages: 69-80
• Publication/Series: Journal of White Collar and Corporate Crime
• Volume: 2
• Issue: 2
• Full text: - 243 kB; Download statistics
• Links: http://dx.doi.org/10.1177/2631309X20970477
• Document type: Journal article
• Publisher: SAGE Publications
• Topic: Other Social Sciences not elsewhere specified
• Keywords: pharmaceutical industry; responsive regulation; self-regulation; corporate crime; off-label; marketing
• Status: Published
• 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
• ISBN/ISSN/Other: ISSN: 2631-309X