Requirements for promotional information and claims. Subtopic 3: Claims must be up to date
It is important to check that claims represent an up to date evaluation of all of the evidence and that there is no ‘cherry picking’. You may be dealing with an issue of emerging scientific opinion or controversy i.e. there is no single agreed-upon view – in these circumstances balance is very important.
Remember also that claims can soon become out of date in rapidly changing therapeutic areas. Claims of being ‘the only agent to show….’ or ‘the largest trial ever conducted’ etc may not be true for long, and need to be checked regularly for accuracy.
In keeping with this requirement you should also note that approval for assets becomes invalid if there is a significant change in prescribing information, in particular any additional or strengthened contraindications, precautions or side-effects.
Consider this example
Claims must be up to date
In the UK Wyeth complained about claims that appeared in a Roche media statement because they were incorrect and did not reflect an up to date view of all the evidence. The claims were:
‘New Data Reveals Tocilizumab Is The First And Only Biologic Drug To Show Superiority Over Current Standard Of Care In Rheumatoid Arthritis'
and
‘No previous biologic therapy has demonstrated superiority compared to [methotrexate] MTX’
The statements implied that no other biologic agents had been shown to be superior to methotrexate. However Wyeth showed there was a wealth of evidence supporting the superiority over MTX of other biologic agents with existing marketing authorizations and so the claims were ruled in breach.
