Off-label promotion of prescription medicine: is it ever justifiable?

Off-label promotion has attracted intense scrutiny from regulators in recent decades resulting in many pharmaceutical companies paying hefty penalties for illegal marketing practices. At the same time, the pharmaceutical industry has accused governments of applying double standards by encouraging the use of cheaper off-label alternatives to registered treatments, and defended their ‘right’ to promote off-label drugs on freedom of speech grounds. However, the debate about off-label promotion and the prescribing that results has largely failed to address the issue that really matters – what impact does off-label promotion and prescribing have on patients and the health system? In this paper we explore the benefits and problems with off-label prescribing in order to determine whether off-label promotion is ever justified, and if so, under what conditions. KEYWORDS: off-label; promotion; misbranding; regulation; pharmaceutical industry; prescribin