689 - Non branded APS I just read the following Ask PAAB questions and I require clarification: Are we required to send material on disease awareness to the PAAB, even if there is no product mention? Hide Answer [-] PAAB Code section covers editorial pieces generated by a pharmaceutical company. That means the piece would not exist without the pharma company's financial involvement. The PAAB reviews editorial pieces where healthcare products are mentioned. See Code s7.8. Therefore, if you are talking about mechanism of action of how a ...
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continued ... therapeutic class works, and the piece is sponsored by a healthcare product manufacturer, I would say that would require PAAB review because it would be difficult not to allude to the sponsor's product and it would appear to promote the sale of that product indirectly. See Code s11.1 for a definition of "advertising" applicable to the PAAB code. Section 1 describes the scope of the PAAB Code. Editorial pieces about disease awareness that do not mention healthcare products directly or indirectly through class would be exempt from PAAB review. Keep in mind bundling that type of piece with product advertising would make the whole thing "advertising" subject to the regulations. My question: I am working on a non-branded piece for a pharma company that will definitely send for PAAB approval. It will talk about the co-morbidity involved with a certain disease, and how this co-morbidity affects quality of life. There will be no product mention. I don't even know if this truly needs to go through PAAB or not. But assuming PAAB approval is required, what type of references would be considered acceptable in terms of talking about typical patient symptoms with various co-morbidities, and medical tests that are done to identify or qualify those co-morbidities. For example, if we want to use medical guidelines that are published in a medical journal to talk about the medical tests required to identify a particular co-morbidity, would that be acceptable? Any tips on what would not be considered acceptable for this type of APS so that I can steer clear from these issues right from the start?
Response: Unbranded disease information should be supported by authoritative sources. This could include published medical textbooks or guidelines. The PAAB review will assess alignment with the authoritative source and it will act as a check that the content does not indirectly allude to the sponsor’s (or a competitor’s) product. If the piece does not include mention or allude to treatment in any way, and is restricted to disease type information, then it may be exempt from PAAB review. This can be assessed during the review process if you are unsure.
