Activities Prior to the granting of a Marketing Authorisation

A marketing authorization (MA) from a regulatory authority is a licence to a pharmaceutical company to promote a product within its terms. However there are occasions when your audience may 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 carried out by non-sales personnel to avoid them being perceived as promotional.

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

Examples of situations where you might provide off label information because there is an established expectation are:

  • A press announcement to the financial media about a major milestone with a pipeline product
  • Materials for medical media about an important clinical trial for a new indication or product
  • An investor briefing document
  • Employee communications

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. Here are a few examples from the United States:

GSK - July 2012

GSK agreed to pay $1.043 billion relating to false claims arising from off-label promotion. Alleged offences included promotion its asthma drug Advair, for first-line therapy for mild asthma patients for which it was not approved. Also promotion of Lamictal an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management.

Johnson & Johnson - November 2013

Johnson & Johnson agreed to pay $1.391 billion to resolve false claims resulting from its off-label promotion of Risperal, Invega and Natrecor. Risperdal was approved only to treat schizophrenia, but was promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.

AstraZeneca - April 2010

In April 2010 AstraZeneca made a $520 million settlement to resolve all civil and criminal liability with respect to illegal promotion of the anti-psychotic drug Seroquel. Approved by the FDA in 1997 to treat manifestations of psychotic disorders, in 2000 the FDA subsequently approved Seroquel for short-term treatment of schizophrenia, bipolar disorder, and bipolar depression. Between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA, including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.