382 - I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only "on-label" information, and further provided the Rep does not include any summary of the article, but does discuss the approved benefits of Product X during the call, would not be considered advertising?



  • This would indeed be considered an advertising activity. The activity clearly relates to the manufacturer’s product and the context in which the activity is unfolding, a promotional (a sales call/visit). This is why you’d want to impose some restrictions including those listed in your question to ensure compliance with legal requirements (e.g. on-label). You’d also want to ensure that the specifics of the activity are aligned with the industry ethics standards. However, there is no advertising content to submit to PAAB in your scenario. PAAB code 1.5 elaborates on the exemption as it relates to materials that have been independently controlled and prepared, with industry involvement limited to purchase and/or sponsorship of the distribution.


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