Failure of Responsive Regulation? Pharmaceutical Marketing, Corporate Impression Management and Off-Label Promotion of Enzalutamide in Europe

Abstract

“Responsive regulation” has been proposed to offset pharmaceutical industry illicit behavior 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.