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  Responsive search ads
  J Jennifer Carroll

  Hello @Maryssa

  Great question as I can see where there might be some lack of clarity. The description of the “responsive ads” was intended to address the unique nature of these “small space ads”. Other parts of the Code and submissions guidance (including the Guidance document for Online Activities) continue to apply when there is targeting and/or keywords that cause the ad to surface. We have included the SEM and SEO in the same review efile as the Google responsive ads.

  This previous PAAB Q&A also covers some general principles which may be useful.

  DTCA/I, consumer secondary audience

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  RMT/RMM presentation by MSLs
  J Jennifer Carroll

  Sorry @HollyMed this one slipped through the cracks.

  Per the RMT guidance document, if the piece is intended to be detailed by a rep to an HCP, it requires going through the standard PAAB review process (i.e. the piece would be subject to all PAAB Code provisions relating to APS). Presentation of the safety data would be subject to the requirements of the PAAB Code. Give the above document a read and this Q&A and let us know if they answer is still unclear.

  Miscellaneous

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  Linking out to pre-proof journal articles
  J Jennifer Carroll

  Hi there,

  PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

  CME, educational material, Reprints, reports, textbooks, independently created content

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  Controlled Substances – Clarification on Rules for Promotional and Informational Materials
  J Jennifer Carroll

  This post was answered through our office earlier but we will post the answers here as well.

  1. No, only opioids are subject to the Health Canada terms and conditions for advertising.
  2. It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.
  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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  Outdated indication
  J Jennifer Carroll

  This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.

  Let’s look at a few examples of where it would not be acceptable.

  1. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
  2. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
  3. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.

  If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

  PAAB Code

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  Controlled Access Program (CAP) linkage to PSP enrolment form
  J Jennifer Carroll

  Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.

  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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  References and Attestation Letters for Broad Coverage Claims
  J Jennifer Carroll

  Hey @dmauri, we haven't forgot about this question. It promoted an internal discussion to find the best solution moving forward. We'll look to get a full response posted some time next week. Thanks.

  Claims & Support/References for Claims

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  Product costs claims
  J Jennifer Carroll

  Hey @dlew
  Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.).

  Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

  General Discussion