Key Topic 1: Encourage Rational Prescribing – Broadened Indication
Often licensed indications have specific caveats or important conditions associated with them.
This can make some indications very wordy.
It is always best to quote a licensed indication faithfully.
If you do see an indication paraphrased (perhaps because of space constraints) you need to think about whether this results in a broadening of the indication.
Take a look at the following examples and decide whether the indication seems ‘broadened’
Example 1
Actual licensed indication: Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
‘For COPD’ is a broad claim given that the licence is ‘to relieve symptoms in adults’. However this may be acceptable if the full indication was given elsewhere on the piece.
Example 2
Consider the following claims for the product Sotradecol which is licensed in the US:
‘for the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit to risk ratio should be considered in selected patients who are great surgical risks’.
Webpage claims:
Well-Known Molecule in the US Sclerotherapy Market
“SotradecolTM is now available through AngioDynamics, Inc. for use in both sclerotherapy clinics and hospitals “
Which of the following do you agree with?
- Provided the claims are true and can be substantiated they are approvable
- The claims imply that the product can be used in ALL sclerotherapy patients and procedures
- The claims broaden the indication for the product
- This constitutes off licence promotion
Ruling
An FDA warning letter was issued as the FDA deemed that failure to mention the material limitations in the licensed indication effectively ‘broadened‘ the indication for Sotradecol.
