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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467 - To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.” Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...
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453 - We are creating a branded device for pharmacist’s physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/and social protocols, with specific brands of medication. Because this piece is never given to the patient, it comes under the same content rules as tools the patient would take home. Please let me know if you want the device.
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432 - With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions "treatment" without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait.
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410 - If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination. The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product. The company does not have any ability to alter content if there is a comment from PAAB. We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way). We are running into similar issues...
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389 - I would appreciate clarification of the Explanatory Note for 6.6 that says "Now on provincial formulary" (or equivalent). Does "or equivalent" allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the formulary and it is that new strength of Product X that is being announced as "Now on Provincial Formulary". Thank you!
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382 - I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only "on-label" information, and further provided the Rep does not include any summary of the article, but does discuss the approved benefits of Product X during the call, would not be considered advertising?
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369 - Hi Patrick. Accreditation for a CHE program has expired and the company wants to turn it into an OLA. The role of the reps is restricted to logistics only and the content is all on label. The program has been developed by HCPs and is presented by trained HCP speakers. Does the OLA content need to be reviewed by PAAB? Thank you.
