Off-label promotion of prescription medicine

is it ever justifiable?

Narcyz Ghinea*, Wendy Lipworth, Ian Kerridge

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)359-363
Number of pages5
JournalTherapeutic Innovation and Regulatory Science
Issue number3
Publication statusPublished - May 2015
Externally publishedYes


  • off-label
  • promotion
  • misbranding
  • regulation
  • pharmaceutical industry
  • prescribing

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