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  3. Unbranded patient counselling materials
PAAB Notice
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.

Unbranded patient counselling materials

Scheduled Pinned Locked Moved PAAB Q&A
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  • K Offline
    K Offline
    karen.taylor
    wrote on last edited by
    #1

    Our client will be developing materials for an unbranded education program, with the intent to provide disease educational tools to a nurse who will utilize them in counselling IBD patients who have been referred from a GI for additional disease education. There would be some balanced information around available treatments within this content.

    In terms of how these materials would be submitted to PAAB for review, would they be classified as a DTCi review (given they are unbranded and intended for people with IBD who have not been prescribed any particular prescription therapy)? Or would they be considered unbranded "patient" materials?

    Our client has asked us to seek official confirmation from the PAAB on the direction we are providing. 🙂

    Jennifer CarrollJ 1 Reply Last reply
    0
    • K karen.taylor

      Our client will be developing materials for an unbranded education program, with the intent to provide disease educational tools to a nurse who will utilize them in counselling IBD patients who have been referred from a GI for additional disease education. There would be some balanced information around available treatments within this content.

      In terms of how these materials would be submitted to PAAB for review, would they be classified as a DTCi review (given they are unbranded and intended for people with IBD who have not been prescribed any particular prescription therapy)? Or would they be considered unbranded "patient" materials?

      Our client has asked us to seek official confirmation from the PAAB on the direction we are providing. 🙂

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @karen-taylor

      Code section 1.4.D states “The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional.”.

      From the provided description, it appears that these pieces would be considered patient materials that are subject to the PAAB code.

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