713 - Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.
-
The main message conveyed in a corporate APS must be related to the company and its programs or services. If the messaging in the piece is strictly related to broad program-level messaging (e.g. a total of 1000 patients across studies in our cardiovascular research program), then the piece may meet the requirements of a corporate APS. That said, discussion of ongoing studies for an existing portfolio of products would likely be reviewed as a branded APS, as it relates to individual brands. This information could potentially be presented in a single APS as a co-promotional tool, with the information relating to each individual brand being separate and distinct. Reference to the ongoing studies must be made in a non-promotional context, with no prominence on information that has not been authorized by Health Canada. Be mindful that as branded tools, these pieces will require the indication and fair balance copy. Refer to AskPAAB question 223 for more information on how we review ongoing studies, including studies involving off-label use, in branded APS.
-
@jennifer-carroll if a group of products could potentially be presented in a single co-promotional tool, as you mention above, can you please elaborate on what you mean by: "with the information relating to each individual brand being separate and distinct"? And to be clear, I am asking about how information from the TMA gets presented, not the ongoing trials.
For instance, do you mean that info from the TMA (i.e. efficacy, safety, dosing, MOA, etc.) relating to each individual product/indication has to be presented as a separate and distinct module within the co-promotional tool?
And are there any considerations you can share when it comes to presenting a group of products/indications within a single APS? -
Hey @constance
The information from the TMA relating to each individual product promoted does not necessarily need to be visually separated into its own distinct module within a co-promotional tool though this does appear to be one approach that would likely satisfy the statement. In essence, there should be clear delineation between characteristics/features that pertain specifically to each product. When presenting a group of products’ indications and/or various data, it is important that they appear clearly separate from each other so as not to suggest combination use, additive effect or comparative claims as some examples. In addition, when presenting features of the products, switching back and forth, grouping or mixing presentations may create erroneous impressions or lack of clarity. It’s not possible to provide an exhaustive list given the variability between products, therapeutic classes, claims placement, headline/subhead positioning and emphasis, creative, etc. If this is in reference to a specific piece, we suggest submitting for an opinion or a consult meeting.
