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    • B

      Pre-NOC submissions
      • brendaarmit1

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      B

      @jennifer-carroll Thank you Jennifer. That does help.

    • A

      Unbranded Counseling Tool on clinical trials
      • adriana.c1

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      Jennifer Carroll

      Afternoon @adriana-c1

      In general, the piece you are describing could be created if executed properly. During creation, look to ensure that the copy is written in patient friendly language, non-promotional, supported by standard setting organizations, and does not favour one product/class of products. Asking yourself the following two questions can also help guide your content creation:

      Could a reader guess who the sponsor of the piece was (in the absence of the sponsor's logo)? Would a competitor be equally as willing to sponsor this unbranded piece?

      The answers should be “no” and “yes” respectively. Ensure that it is clear that the intent is for the piece to be a patient counselling tool.

    • G

      Branded and Unbranded APS in Conference Setting
      • georgian21

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      Jennifer Carroll

      Hey @georgian21

      This does give us pause to consider the nuance of the scenario. The main concern is separation. When we put unbranded content with branded, it creates an association that brands everything. Even if it is a separate therapeutic area, the question is, can we ensure that there is no suggestion that the product has implications (e.g. safety/efficacy) in that therapeutic area? We’d also have to consider the therapeutic areas as some are more closely related than others.

      Example:
      - Drug A (renal or CV drug); Drug B/C (diabetes)
      - Drug A (lipid drug); Drug B/C (HIV)

      This type of question might be more suited for an opinion so that we may assess the intricacies.

    • G

      LinkedIn
      • GMC

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      Jennifer Carroll

      Hey @tmcd

      The PAAB code applies to Canadian companies or to companies targeting content to Canadian healthcare professionals and patients. Please see the Health Canada document “The Distinction Between Advertising and Other Activities” for further clarification on how the content and role of the sponsor may impact if a piece is considered advertising.

      In the example provided in your question, a truly disease state only piece with no messaging about treatment and no direct or implied link to a product the sponsor has a vested interest in, may be exempt from PAAB review. There are variables that could render the piece subject to review (e.g. focusing on a disease mechanism of action for which only exogenous compounds target or are being developed to target; inclusion of a link to a brand page or treatment-related information, etc.). Another note of caution is that this would likely be considered direct to consumer advertising and would be subject to consumer regulations as well.

    • T

      pre-NOC and post NOC disease state APS
      • turnapage

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      @jennifer-carroll Thank you for your help

    • T

      Pre NOC Communications
      • turnapage

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      @jennifer-carroll Thank you very much for the advice.

    • Jennifer Carroll

      765 - I believe there is a condition in the code that we can have APS reviewed/approved by PAAB even before NOC ? Where can I find this in the code for proper guidance. Thanks.
      pre-noc • • Jennifer Carroll

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    • Jennifer Carroll

      715 - Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca
      • Jennifer Carroll

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    • Jennifer Carroll

      628 - Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?
      • Jennifer Carroll

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    • Jennifer Carroll

      578 - Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general information regarding disease state. Do we need PAAB approval or ASC approval alone is sufficient?
      • Jennifer Carroll

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    • Jennifer Carroll

      556 - Can we provide marketing items such as pencils, cups or post-it with braded name only of future prescription drug currently under NOC review (not approved yet in Canada) but FDA approved. Distribution would be to general Canadian public and health care practionners during Canadian conventions.
      • Jennifer Carroll

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    • Jennifer Carroll

      550 - Can a company have a corporate pre-launch journal ad that speaks to an unmet need/care gap for a disease state that they don't yet have a product?
      • Jennifer Carroll

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    • Jennifer Carroll

      549 - A company is entering into a new disease state in which they don't already market a product in Canada.If they produce a corporate ad (pre NOC) indicating that they are now entering into the therapeutic area/disease state, can they mention the therapeutic area/disease state in the ad?
      • Jennifer Carroll

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    • Jennifer Carroll

      473 - Dear Patrick, I have a question regarding references that can be used in unbranded pieces in the category of cold and flu. As you know, the active ingredients in many cough, cold & flu products have long since become generic and in fact are used across a number of different products... I was wondering if experimental studies (e.g., in vitro/cell culture/ELISA), which do not use any brand specific sources of the molecule (i.e., generic), could be used in unbranded pieces to educate HCPs on the properties of the molecule (with any necessary caveats that clinical significance cannot be determined)? Thanks!
      • Jennifer Carroll

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    • Jennifer Carroll

      371 - What are the rules regarding having Unbranded DTC materials aesthetically similar to Unbranded HCP materials? Can they share graphic elements, fonts, images?
      • Jennifer Carroll

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    • Jennifer Carroll

      311 - If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?
      • Jennifer Carroll

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    • Jennifer Carroll

      246 - Are unbranded printed materials focussing on disease area with no mention of drug treatments and that are presented to Health Care Professionals by Sales Representatives exempt from PAAB review?
      • Jennifer Carroll

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    • Jennifer Carroll

      238 - Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?
      • Jennifer Carroll

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    • Jennifer Carroll

      236 - I am working on an unbranded piece speaking to medication adherence in general. Can I put product logos (without indication or claims) on it if the content does not cover indications or treatment in any way?
      • Jennifer Carroll

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    • Jennifer Carroll

      235 - Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?
      • Jennifer Carroll

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