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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?
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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.
