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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164 - I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?
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159 - If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved? I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?
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149 - We want to download our PAAB approved detail aid on an electronic pad for our reps to use. If there are no changes to the detail aid, do we need to re-submit to the PAAB? Second part is if the PAAB approved detail aid on the electronic pad has some interactive features such as animation of some charts or graphs do we need to re-submit it to the PAAB. If yes, in what format would it be submitted?
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134 - I'm puzzled by an ad on the cover of a specialist journal, announcing that a product is now availabile in Canada. There are no other claims or description of the product, other than suggesting the physician call the pharma company for more information or samples. I'm puzzled becuase the ad has no balance copy, no warnings, and has not been PAABed; there is no prescribing information. The company must feel that the ad falls out of the scope of the PAAB Code, but i don't see any of the exemptions applying. Plus, launch is a time when MDs are particularly in need of info regarding safety information. The masthead says that all drug ads have been cleared by PAAB, but this is clearly not the case. Is there something I am missing?
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132 - A variation to question #89. An international speaker has been asked to make a presentation to a Canadian meeting of healthcare professionals about a product which has recently received its NOC. Her talk is not accredited, or about the disease category, but is focussed on the product itself which is mentioned by brand name. The slides, which are not printed out for distribution at the meeting but used onscreen, are prepared by the speaker and not by the sponsor. Do the slides require PAAB preclearance?
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120 - We are considering producing a patient brochure in an alternate language other than french or english that remains valid until mid 2010 by PAAB. I understand that PAAB does not require a review if this is simply a translation and printing however in the last two months the Merck logos and trademarks have changed. If we change the trademarks/logos on this brochure do we require an additional review seeing as we are only changing the logos to reflect the new company name and then printing this new language which would have the same mid 2010 expiry date. Content of the brochure will not be changed.
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112 - As a private clinic we are planning to prepare advertising material to be played on TV only to the patients waiting in the waiting area. The contents of these ads will be prepared by specialists in different medical disciplines. This will mostly contain OTC, NHP products. Is this activity subject to PAAB review?
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103 - If we have a non-branded poster, talking about a disease and with a call to action: talk to your doctor. This poster will be given to the secretary of the doctor's office by the pharmaceutical representative and then will be posted in the examining room. Is this subject to PAAB review? Also with the poster there will be a booklet disease oriented for patients also to be given to secretary to be left in the examining room. Is this subject to PAAB review? With that poster there will be a card to be given to the patient by the doctor with the same message and a call to action (talk to your doctor) is this also subject to PAAB review?
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102 - Can a pharmaceutical company provide ,upon request from a Third party HCP controlled website, a company produced educational slide deck ( disease and treatment) that has not been reviewed and approved by PAAB.The third party website wishes to provide these educational slide kits to their members as self learning resources.
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89 - Would a live event whereby healthcare professionals are invited to hear key opinion leaders discuss unmet need in a therapeutic area and a drug that has just obtained NOC be deemed subject to preapproval by PAAB? The live events would be sponsored by the pharma company whose drug has just obtained NOC. The purpose would be to inform prescribers of the approved indications and appropriate clinical usage. The program would not be accredited.
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87 - We are producing a directory of canadian clinics that offer a specific test. There will be an introduction outlining why the test is important, how it is done etc. The booklet will be sponsored by a drug company (corporate logos will be on the cover) but there is nothing in it that mentions their or any other company's drug products (and they have no affiliation with the tests, clinics or instruments used). The booklet will be distributed by the sponsors reps as a service. Healthcare providers will offer independent review of the content. Does this require PAAB review?
