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?
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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.
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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.
@jennifer-carroll Assuming a product has several ongoing trials as per the PAAB definition of "ongoing", can the APS include study design, inclusion/exclusion criteria, and patient characteristics? I don't believe this part of the question was addressed. More specifically, within a branded APS (like a detail ad) can tab be added, away from the clinical data, with a table describing all ongoing trials.
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@jennifer-carroll Assuming a product has several ongoing trials as per the PAAB definition of "ongoing", can the APS include study design, inclusion/exclusion criteria, and patient characteristics? I don't believe this part of the question was addressed. More specifically, within a branded APS (like a detail ad) can tab be added, away from the clinical data, with a table describing all ongoing trials.
Hello @constance
Similar to our response above, a description of the outcomes for assessment and the listed study information noted in your question, may be included in an APS in a non-promotional manner , prominently disclaimed for the off label uses, and also prominently labeled “Ongoing studies”, in a separate tab/page that is away from the promotional content of the APS. Please also see this Q&A 223 for additional information on the presentation of ongoing studies in a non-promotional manner.
