538 - What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?
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The PAAB considers the TMA in it’s totality when ultimately determining what is and is not acceptable in advertising. It’s therefore impossible to predict the best approach for your situation given the limited information we have. We will however do our best to provide information which steers you in the right direction. The indication statement describes the Health Canada approved use for the drug and sets the boundaries for patient selection. If the indication limits use of the product to “monotherapy” then all information in advertising would be restricted likewise. Any discussion of combination use would be considered off-label advertising. While inclusion of “monotherapy” in the dosing section may not appear to have the same degree of limitations, it is important to remember that APS are still required to be consistent with and within the limitations of the product monograph. Promotion of combined use would still be questioned without the appropriate supporting copy from the TMA (i.e. studied in combination in clinical trials, dosing section, etc.). There are many PM factors which could impact the answer to your question. For example, if the indication states that the product is generally to be combined with other therapies, and the dosing section of the PM provides a specific scenario in which monotherapy may be considered, content relating to use in combination therapy would be required to be presented as the primary message. This content could be followed by content completely & accurately capturing the PM scenario in which the product may be considered as monotherapy. As there are many different possible PM scenarios, we invite you to submit your scenario through the PAAB’s opinion review service (see the fee schedule on the PAAB website).
