Clifford Chance

A Comparative Review of Off-Label Pharmaceutical Use and Promotion in Europe, the US and China

1 March 2012

In general terms, the phrase 'off-label' when applied to the use of drugs refers to the application of a pharmaceutical product outside the scope of use approved by the applicable drug administration authorities.1 Off-label variances in that scope often pertain to its indication, patient group, dosage and duration of treatment.

The primary reason for off-label use is to address a deficit in effective approved drugs. This occurs mainly due to the lag in the discovery and development of effective drugs and their approval for authorised use by the relevant drug authorities. Further, if a drug is discovered to be effective in treating a second indication, obtaining the approval to treat that indication 'on-label' often involves a second regulatory pathway that that can be both lengthy and costly.

Download PDF