Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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266 - If a journal ad highlighting a product portfolio (and therefore, includes product logos)were to make the following statement, would it be considered a claim of merit, if non-specific to any one drug: "[Company] committed to gastrointestinal care for over 80 years." If so, would the lowest level of fair balance suffice, according to the new PAAB Code?
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192 - Is it necessary, whenever a letter pertaining to your product is sent to a government official (either elected or part of the public service, at all levels of government) to include a copy of the Product Monograph if you refer in passing to an issue you may be having as it relates to your drug. For example, if we were bringing to the attention of Minister XYZ about Product A not being approved fast enough by internal bodies to meet the demands of physicians/patients, would we then have to include the PM simply because we mentioned the name of the product? Also, is it necessary, in private correspondence to government officials that is exempt from PAAB pre-clearance and non-promotional, to include both the generic name of said product, the dosing information, etc?
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126 - If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.
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92 - I have a question regarding minimum font size for safety and balancing copy. It is clear in the PAAB code that it is required to be 75% of the main claim in size. The reasons for this are obvious if one is producing a journal ad or printed piece - the balance copy must be legible. However, if the APS is a 10 foot high panel, does the same ratio apply? In such a case, the balancing copy is almost beyond legible (too big) and consumes the entire bottom of the panel.
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80 - I recently received a copy of your December newsletter which refers to changes that will be taking place on April 2009. With respect to 2.4.3, would you consider a non-prescription, schedule D vaccine to fall into this category? And what about a Schedule F drug, that is non-prescription in Ontario?
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65 - Is it necessary to include "Product Monograph available on request" on a direct mail or leave-behind that advises doctors of a drug now being covered on provincial formulary for a specific indication? No claims other than "Brand X now covered on Formulary y for z" (will have the exact wording from the provincial formulary). Understand that fair balance copy needs to be included and this will be submitted to PAAB.
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62 - Revised October 2019: Is PAAB concerned if we are correcting typos, punctuation and spelling from a Product Monograph as it enters into a formatted monograph? Some monographs contains such errors yet pass through Health Canada approval. Does PAAB or Health Canada have a concern if these errors are corrected as the product enters promotion?
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61 - If an APS makes a usage claim (number of prescriptions or patient-years, for example) for an agent and shows the product logo, but provides no therapeutic claims for the product, does the indication have to be included? Other than an acceptable reference for the usage claim, is there any other balance copy necessary?
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44 - I support a number of small products which are supported by one sales force. In order to simplify detailing efforts, I would like to produce one detail aid for all the products, with a few pages dedicated to each one. When it comes to the prescribing summaries, should these be placed together at the end of the detail aid, or with the pages related to that product?
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15 - Are there specific APS guidelines for corporate booth panels? Is it possible to create a panel/poster that just lists the product and its indication and not provide full product balance (i.e. adverse events and contraindications)? Full product balance/PI would be available at the same corporate booth.
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