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PAAB Q&A

1.1k Topics 1.7k Posts
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.

  • 248 Topics
    415 Posts
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    We're interested in developing a single printed APS that can promote updated public coverage (a new patient population) in different provinces. The intent is to use a broad message of "covered in DiseaseX in your province" (without specifying the province), and only disseminate the APS in provinces for which the coverage update has been confirmed and published. This is similar PAAB forum topic 196 (https://forum.paab.ca/topic/196). Due to financial constraints, we are unable to make a different APS for each province (10 different APSs). We expect online formularies for various provinces to publish criteria much later than the actual formulary listing. Therefore, we will likely need to use an attestation letter as our reference for the formulary criteria + listings. My questions are: A) For our initial submission, do we still have to provide the anticipated public coverage criteria for each province in which the APS will be disseminated? B) For final approval, do we still need to provide the confirmed public coverage for each province in which the APS will be disseminated? Our concern is that this delays the piece for provinces that get the updated coverage earlier. Thank you in advance!
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    57 Posts
    C
    @jennifer-carroll Thank you this helps!
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    7 Topics
    11 Posts
    Jennifer CarrollJ
    Hello @abhi-patel While consumer advertising for Schedule D health products (e.g., vaccine), and ethical schedule health products fall within the scope of PAAB services, consumer advertising for OTC and NHP products does not. Please note that Health Professional directed advertising of these products falls within the scope of the PAAB Code.
  • 38 Topics
    56 Posts
    Jennifer CarrollJ
    Hi @tk2022 Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.
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    125 Posts
    U
    Thank @Jennifer-Carroll , I will look into that and follow up if necessary. Hopefully a more simple question, can non-clinical characteristics of two schedule 2 products be compared in the DTC setting? E.g., Store Product X under conditions A, Store Product Y under conditions B?
  • 71 Topics
    119 Posts
    Jennifer CarrollJ
    Hello @mimi77 During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.
  • 175 Topics
    219 Posts
    H
    Hi, Are controlled drugs listed under Schedule I of the Controlled Drugs and Substances Act subject to the same marketing and advertising regulations as opioids? Is it permissible to create and provide promotional materials for controlled drugs to healthcare professionals or medical staff? If not, can product fact sheets still be distributed?
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    127 Topics
    201 Posts
    H
    Just wondering if this question is appropriate for the forum. Please let me know if I should ask another way.
  • 60 Topics
    72 Posts
    Jennifer CarrollJ
    Hey @dmauri Section 7.3 of the PAAB Code states “Advertising with Product Claim Link to Terms of Market Authorization: One of the following must appear prominently within the main advertising message of the APS: Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number. The definition of “Terms of Market Authorization” can be found in the Code and reads as follows: Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada. When a Product Monograph is the basis of authorization, it should be linked. If authorization was granted based on a Product License, providing a link to that document would meet the requirements of section 7.3. The TMA document would be the basis for review of the ad.
  • 8 Topics
    16 Posts
    Jennifer CarrollJ
    Hey @vt Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section. For example, the “Content and Context Factors” section in the “Overview” states: • A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if: • the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization Within the Educational Activities section, things that could make the piece promotional are: • The limitations of the data and of the health products are not adequately discussed • Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.
  • Unbranded emails with corporate attachments

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    Jennifer CarrollJ
    Hey @rcolbear Yes, the entirety of the message delivered should meet the standards of code section 1.5E in order to not be subject to PAAB preclearance.