385 - Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.
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For consideration as evidence in HCP advertising, guidelines must be endorsed or recognized by an authoritative medical body. It is not sufficient for the guidelines to be published and peer-reviewed. While some guidelines are published, they may not be endorsed or recognized by an authoritative medical body and therefore may not be reflective of current medical practice (thus falling short of meeting PAAB code section 3.2). Note that the guideline (and the endorsing medical body) should be nationally recognized. We can consider authoritative North American or U.S. guidelines in the absence of Canadian guidelines.I note that your question relates to unbranded pieces. Clients are often surprised to learn that acceptable guidelines cannot be used to support advertising content which extends beyond a product’s monograph (or all monographs in a class), EVEN IN UNBRANDED PIECES (i.e. PAAB 3.1, 3.2 & 7.5). Please keep this in mind.
