537 - Can a sales rep use a slide deck that discusses the study design, inclusion/exclusion criteria, and patient characteristics for study in an indication for which they don't yet have approval?
Jennifer Carroll last edited by
Revised August 2019: In this scenario it is important to differentiate between completed studies and ongoing studies.
If the off-label study is no longer in the data gathering stage, then the study cannot be discussed in an APS until the TMA is adjusted accordingly.
A study which discusses outcomes outside of the Terms of Market Authorization can be discussed if it is on-going. The discussion should be limited as per PAAB code section 3.2.3:
"Reference to research or ongoing studies may be made in a nonpromotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada Terms of Market Authorization, should not be mentioned in advertising". PAAB defines “ongoing” studies as studies which are still within the data gathering stage. Once data gathering is complete and/or an interim analysis is conducted, the study no longer meets the definition criteria for an “ongoing” study, even if the data has not been published, made public, or a follow-up/extension study is underway.
Note: If the product does not have any indications in Canada, then even the use of ongoing studies in advertising would not be acceptable.