Miscellaneous
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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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263 - Has the PAAB ever considered a "priority review" stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission Coordinators could limit Files to those of formulary/safety content, or those of shorter length.
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254 - I'm curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn't this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also has DTC ads and posters in addition to the website.
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250 - In addition to the automatic renewal email I just submitted, it would be AMAZING if the final PAAB approval letter (or final communication letter -- for both languages if applicable) was included in the eFile library along with the historical files. There is so much turnover in agencies, it would be incredibly helpful to have a complete document history in one location to help alleviate anything slipping through the cracks.
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249 - This isn't really a question, but it would be great if PAAB were able to send an automatic email out 2 months before expiry on electronic media/websites. I am sure this is an easy thing to tag to the submission database and would be of great value to agencies and clients. Perhaps it is something that users can opt in to if there are any concerns. I hope you will consider this.
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245 - It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada's Drug Product Database to anyone who searches, and these are unrestricted. However, I understand that PAAB reviews company prepared websites specific to products, even if they only contain information straight from the PM without any editing. If it is okay to post the PMs on the corporate websites and other publically available portals, why do the designated product websites that only contain the PM information require PAAB review? Thanks!
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241 - When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you.
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226 - I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what...
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224 - I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!
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220 - A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions: 1. How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND 2. Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data? Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!
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210 - Would PAAB approval be required for cards containing the Ontario Drug Benefit (ODB) Reimbursement Codes for a drug class? *content is copied verbatim from the ODB website *OBD website/URL is referenced *no mention of drug name or drug logo *no mention of pharmaceutical company *to be distributed by drug rep
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162 - Please advise as to whether there are any particular requirements related to a US manufacturer providing medical information letters to Canadian physicians' unsolicited requests for information for a drug not authorized for marketing in Canada. The letters would be intended only for medical information, not for advertising purposes.
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79 - Could you please provide some clarity around the definition on Formulary Kits as described in "The Distinction Between Advertising and Other Activities". Specifically, is it appropriate for a company's sales representative to distribute formulary kits to formulary committees in a hospital setting?
