Activities Prior to the granting of a Marketing Authorisation
A marketing authorisation (MA) from a regulatory authority is a licence to a pharmaceutical company to promote a product within its terms. However there are occasions when health professionals will need information about a product or an indication before the licence is granted to the company i.e. information that is outside of the terms of the MA or ‘off label’.
The provision of off-label information about products is allowed under certain circumstances, and these activities are usually carried out by medical personnel to avoid them being perceived as promotional. In this section we will examine these circumstances and look at specific examples that you may be involved in.
The circumstances where sharing of off-label information is allowable are:
- When there is a legitimate business need
- In response to an external request
- When there is an established expectation
Always remember that off label promotion is illegal. Therefore it is vital that the activities and materials that you undertake or utilize in relation to these circumstances cannot be perceived by others as promotional in any way. If you have any doubts seek the advice of a senior colleague.
The sanctions for off label promotion can be very severe.
Consider this example
On September 1st 2010 the Department of Justice in the US made the following announcement:
Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®
At the time Botox was approved to treat cervical dystonia (involuntary neck muscle spasm). It was alleged that Allergan undertook a series of activities to widen usage of Botox to include headache and neck pain. Their materials claimed that cervical dystonia was ‘under-diagnosed’ and that doctors could diagnose cervical dystonia based on headache and pain symptoms alone.
Some of the activities included advisory boards which the authorities deemed as promoting these off label uses.
