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Abstract

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? This paper explores the benefits and problems with off-label prescribing to determine whether off-label promotion is ever justified and, if so, under what conditions.

Keywords

off-label promotion misbranding regulation pharmaceutical industry prescribing

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