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.