The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
628 - Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?
-
The intent of a pre-launch editorial APS should be to increase health care professional awareness and understanding of a specific therapeutic area, or in this case a specific biomarker. These APS should not contain the message that a new product (or indication) is coming soon as this could be construed as pre-NOC advertising and contravene section C.08.002 of the Food and Drug Regulations. Discussion of how an exogenous compound may modulate a pathway would be rejected as it alludes to a new drug coming to market. Likewise, we would question the message that this biomarker is an emerging target for the disease, this would be construed as pre-NOC advertising. As this APS is targeting HCPs, it should be submitted for PAAB review.