FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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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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72 - In order for a prescription to be filled for product X, the doctor must submit a form which will function as the prescription to a 3rd party distributor. the form also includes the patient's signature which allows the patient to request the 3rd party company to research the patient's insurance coverage for product x on their behalf. There are no product claims on the form (no efficacy, no safety, nothing). Only the doctor receives the form (the patient can not get it any other way then when the doctor makes the decision to Rx the drug for the patient). The drug is restricted to a very specific indication; therefore the form includes the specific diagnosis code to allow the 3rd party to ensure that the drug is no prescribed off label. The form is a strictly administrative document, the pharma company never has access to any of the specific information (no doctor names, no patient names etc...). Am I correct in my conclusion that this would not need PAAB review?
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71 - As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?
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64 - Does exhibit booth panel text generated by head offices outside of Canada require PAAB approval for International conferences and symposia held in Canada? Does an entry in an Exhibit Guide for an International conference or symposium generated by head offices outside of Canada summarizing a recent peer reviewed published clinical trial require PAAB approval?
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60 - Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective? To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.
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47 - If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered. There will be no claims made...only this minimal information. Does a PI need to accompany the offer?
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43 - I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician. When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents? Am I permitted to submit for review a reprint which I would also like to be available for inclusion?
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1 - If a fax were to be sent to physicians stating only the study name (I.e. ABC), what disease area it was studying (i.e. CHD mortality) and the major results (i.e. decreased mortality) but there was no drug mention; but provided a website for the study and a 1-800 number for further information, would this require approval? What if name of the study included both drugs that were compared (i.e. Alefacept Benzoperoxide Comparison)?
