Ask PAAB

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  Yes. PAAB reviewed HCP product branded materials for an OTC product can link to a DTC website branded for the same product if both of the following conditions are met:

  1. The OTC website has been approved by a preclearance body whose scope includes OTC DTC per the Health Canada document "Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising".
  2. The consumer site is identified in the HCP site as a consumer site (i.e. so as to make it clear that this not content that was designed specifically for HCPs)

Could you please clarify the response to Question #232, as it seems to imply that there is no such thing as a true "unbranded" piece. The nature of the Rep-HCP interaction is such that unbranded and branded discussions frequently take place in the same call. It was our understanding that as long as there is a clear transition/distinguishing between unbranded and branded content, that pieces are reviewed separately without assuming linkage.

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  Question #232 asked whether product branded and non-product branded editorial materials should be discussed in the same sales call.

  The fact that the regulations for product branded pieces and editorials are very different lies at the core of the answer to Question #232. All content in a branded piece is reviewed to ensure it is within the limitations of that specific product's TMA (per PAAB code 3.1), while an editorial is reviewed under the provisions in PAAB code section 7.5. It is possible that disease or product class statements in an editorial exceed the limitations of the sponsor product's TMA. As such, a link between that product and the editorial content might contravene section 3.1 of the PAAB code and section 9.1 of the Food and Drugs Act. Code section 6.5.4 of the PAAB code identifies the most common linkage factors: proximity, appearance, sequence, and context. Detailing editorial content which was not reviewed to ensure consistency specifically with drug X's TMA in the context of a sales call in which the rep details about drug X is not that different from placing the editorial content (containing off-label info) in a different section of the product's branded piece. You've created a link whether you have a clear transition or not.

  There is indeed such a thing thing as a true unbranded piece, provided we consider the linkage principles and ensure that we don't link branded and non - branded content.

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  Code section 6.5.4 of the PAAB code identifies the most common linkage factors: proximity, appearance, sequence, and context. Materials don't necessarily need to be provided together in order to be linked.

  If you are unsure, you can always consider submitting a PAAB opinion outlining the specifics about the intended campaign materials and activities for an advisory opinion. See the fee schedule on our website for additional information.

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  The "Submission guidance document" on the PAAB website outlines the escalation process. For your convenience, I have pasted the relevant segment below. The policy is intended to ensure that the reviewer has had a fair chance to resolve the matter and consult internally if necessary. Here is the excerpt:

  Escalation requests will be accepted only after having discussed a written review comment with the PAAB Reviewer, responding in writing and receiving a subsequent PAAB letter about the same issue. If you wish to escalate an issue regarding and eFile, please contact PAAB administrators with a detailed reason for the request, the eFile # and points to be discusses, and the requestors contact information. The administrator will forward the request to the Reviewer of Record and the Chief Review Officer to return the call.

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  It's hard to say that you can or can't use social media to do something. I'd begin by setting aside the fact that it's social media for now. The first question to ask is whether the content/activity is drug advertising. For the purposes of the Act, advertising is defined as including "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device". You can also refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities". You need to consider all aspects of the content/activity, its creation, and it's audience. If the content/activity falls within the realm of advertising, then it is subject to the provisions of advertising. One potential consideration that jumps out is whether this content is a Help-seeking announcement (in which case the company logo is not permitted as per the aforementioned Health Canada document).

  Possibility A: It is not advertising. In this case, your next question relates to social media. Do I have the resources necessary to monitor and intervene as necessary to make sure this stays outside of the realm of drug advertising?

  Possibility B: It is indeed drug advertising. In this case, your next question becomes whether the content/activity adheres the regulations which apply for this audience. If the answer is yes (again after consideration of all factors) your next question is whether you have the resources to monitor and intervene as necessary to ensure it stays compliant with the applicable regulations.

  There are many considerations depending on the specifics of what you are doing. We'd be happy to help you through the regulatory aspects of these questions. Feel free to contact our admin team to discuss how to submit a written opinion. Also refer to the fee schedule on our website.

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  The PAAB code section you are alluding to is s6.4.3. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately.

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  NHPs can satisfy the code fair balance requirements by either of the following
  (i.e. you can choose between 'a' and 'b'):
  
  a) including the indication AND the weblink destination to the product license within the body of the advertisement as described in PAAB code s2.4.3.
  
  b) including all relevant text from the TMA within the body of the advertisement (in which case a link to the TMA is not required). Per PAAB code s7.2.1, "all relevant text" means the medicinal ingredients, the recommended use, all cautions & warnings, all contraindications, all interactions, all known adverse reactions and the dosing information relating to the uses promoted in the APS. This approach also applies to homeopathic products and OTC products. The approach does not apply to any other category of healthcare product.

Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company?

Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue. Only the scientific evidence will be presented concerning the drug.

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  Although many would say sponsored CME is a "Marketing " activity, you should be more concerned about whether or not the activity is covered under the regulations as "advertising". The reason this latter distinction is more important is that advertising is subject to the advertising provisions (and content relating to unapproved products would contravene those regulations).
  Importantly, sponsorship alone does not render content subject to the advertising regulations. The Health Canada policy document 'The Distinction Between Advertising and Other Activities' says the following:
  CME events and scientific symposia related to drugs are sometimes sponsored by pharmaceutical manufacturers. Such activities may not be advertising when they provide a forum for exchange of information on related clinical and scientific issues. The key factor in determining the status of such an activity is the degree to which the programme is independent of the drug manufacturer.
  The information may be nonpromotional in the following circumstances:
   

  • sponsorship by a drug manufacturer is not targeted to specific aspects of the agenda,
  • the sponsor's role is adequately disclosed,
  • the programme is directed to scientists and/or health professionals,
  • the programme allows for exchange of information/debate,
  • the content of the agenda is not influenced by the sponsor,
  • the content of an individual presentation is not influenced by the sponsor where it concerns a drug manufactured by that sponsor,
  • there is no inducement provided to participants,
  • there are no ancillary commercial or promotional activities relating to drug products,
  • the limitations of the data and of the drug are adequately discussed,
  • discussion of an unauthorized drug or indication for use includes a statement indicating that the drug/indication has not been authorized for marketing in Canada, and
  • no reference is made to the availability of unauthorized drugs through the Special Access Programme.

  
  Such an activity may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose of the activity is to promote the sale of a specific drug.
  Moreover, reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a specific drug may be advertising if they are disseminated by the sponsor, or the sponsor's agent, to a wider audience after the meeting.

   

Removed 07/2018

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  When the Product Monograph update is at Final Draft stage as confirmed by a letter from the manufacturer's regulatory department, the PAAB will accommodate up to two pre-NOC submissions incorporating content relating to the new indication. These submissions will not be subject to the standard turnaround time. As with all submissions for review, these APS require approval by the advertiser's medical/regulatory staff prior to PAAB review.

  While waiting for the final approval of the Product Monograph, the company should apply PAAB revision requests to all the items that form the launch campaign.

  Once the update to the product monograph is approved (and the pharmaceutical company receives its NOC letter with an updated control number), additional launch APS may be submitted for PAAB review. Please read the guidance document "Guidance on Submission Process" on the PAAB website for more information.