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Corporations in the pharmaceutical industry face aggressive scrutiny of their business practices worldwide by government agencies and prosecutors. Standing out among the issues most relevant in this regard to industry players and financial investors is ‘off-label’ promotion, marketing the use of prescription drugs outside their approved uses.

Studies published over the past 10 years show that off-label use in the European Union (EU) and the United States (US) is widespread. It is both rational and common to assess whether use of an approved drug should be extended to new patient groups, indications and dosages. The problem is the promotion of off-label use, not necessarily the use itself. A telling indicator of off-label prevalence is the application of significant
resources by government agencies and prosecutors in policing off-label promotion, coupled with the recent headline grabbing instances of off-label prosecutions.

The approaches taken in regulating off-label use and promotion in major
markets differ. Described below are the legal and regulatory framework
and the consequences of non-compliance.

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