104 - If a disease education piece is being submitted (pre-NOC) that contains no branding and no mention of drug or treatment, would a review paper be an acceptable reference?
Jennifer Carroll last edited by
PAAB code 3.1.1 states that "Review articles… are generally regarded as not being high-level evidence to support claims in drug advertising". Having said this, there should be no drug claims in a pre-NOC editorial APS. The PAAB will consider review papers, provided they are published and peer-reviewed, as support for discussion of physiology & pathophysiology content within pre-NOC editorials. This latitude is provided as the science pertaining to the receptor or the metabolic pathway is likely to be new and thus unlikely to have already been incorporated into guidelines and/or textbooks. However, review papers are not acceptable sources of support for messages regarding current medical opinion or practice. Such messages should be supported by Canadian consensus guidelines or authoritative medical textbooks. It is also important to note that the PAAB will question any reference which appears to promote the pre-NOC drug (or its product code) as this could be considered indirect promotion of a drug prior to NOC, which would contravene Section C.08.002 of the Food and Drug Regulations. Please call the PAAB office if you have questions about specific references or pre-NOC editorial content.