153 - Can a pharma company place a product ad adjacent an editorial article in a healthcare journal if the article relates only to discussions about the condition that said product is labelled (no specific drug treatment mentioned)
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I'll assume from the question that the editorial piece contains only disease information with no mention of drug therapy (e.g. no product or class/category). I'll also assume that, in this scenario, the pharmaceutical manufacturer intends for this adjacent positioning to occur. Note that the context would essentially link the disease article to the product promoted within the adjacent ad. With this understanding, the following scenarios come to mind:
In a healthcare professional publication:
This adjacent placement may be acceptable. The disease messaging would need to be consistent with the constraints imposed by that product's Terms of Market Authorization (e.g. product monograph) for that specific disease/condition. For example, if the product is indicated only for mild to moderate hypertension, the ad should not be placed next to a disease article about severe hypertension or the complications associated with hypertension such as heart attacks and strokes. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB would ensure these requirements are met during review of the branded piece (i.e. clients should inform PAAB of the intended context during the review and include the editorial article - or anything known about the article - within the submission).In a healthcare consumer publication:
• If the product appears on schedule F (i.e. a prescription product):
This adjacent placement is not acceptable. This linkage would contravene section C.01.044 of the Food and Drug Regulations for a prescription drug (as the combined entity would exceed name, price, and quantity). The PAAB offers an advisory pre-clearance service for DTCRx advertising. See the PAAB website for details (www.paab.ca).• If the disease article pertains to a schedule A disease AND:
• the product is indicated for the treatment of that disease:
This adjacent placement is not acceptable. As per section 3 of the Food and Drug Act, neither a prescription nor a non-prescription product can be promoted for the treatment of a schedule A disease. This linkage would therefore contravene the regulations for consumer advertising.• the product is indicated & promoted only for the prevention of that schedule A disease:
This adjacent placement may be acceptable. As per section A.01.067 of the Food and Drug Regulations, the non-prescription product (e.g. vaccines) linkage may be permissible. Note that the disease article needs to be consistent with the constraints imposed by that product's Terms of Market Authorization for that specific disease/condition. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB offers an advisory pre-clearance service for DTC vaccine advertising. See the PAAB website for details (www.paab.ca).Please don't hesitate to call the PAAB office if you have any questions regarding this matter.
