67 - If a product has a universally-accepted trait (such as no dose adjustment, no specific drug interaction), but this is not stated specifically in the TMA, can this claim be stated? At times, some things are not specifically stated in the TMA or the TMA is not updated for a period of time. If a trait is universally-accepted, should it not be permitted to make this claim?

  • The PAAB principle is: Generally, you cannot support a claim by omission of fact i.e. the absence of mention of a 'trait' in the TMA (Terms of Market Authorization) does not mean that it does not occur. It only indicates that it was not addressed and we do not know its outcome. For example, if no death were reported in the TMA, it is not sufficient to support a claim that the drug does not cause death unless there is a specific mention that "No death were reported". In summary, if a trait was truly "universally-accepted", it should have no problem getting into the TMA.