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  3. Formulary message - exemption confirmation
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.

Formulary message - exemption confirmation

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  • K Offline
    K Offline
    karen.taylor
    wrote on last edited by
    #1

    Our client has asked for confirmation as to whether a statement of “Another indication for Product X is now on formulary in province X" (not linked in any way to additional product messages and/or any mention of therapeutic area) meets the conditions of exemption for formulary announcement messages.

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

      Our client has asked for confirmation as to whether a statement of “Another indication for Product X is now on formulary in province X" (not linked in any way to additional product messages and/or any mention of therapeutic area) meets the conditions of exemption for formulary announcement messages.

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

      Hi @karen-taylor

      The message “Another indication for Product X” is an unclear claim of product merit and an embellishment which extends beyond Section 1.5Dii of the PAAB Code “(“Materials Not Subject to Preclearance”). It accords significance to the formulary body listing the product for multiple indications. Formulary bodies have requested that coverage not be promoted in a manner that suggests endorsements for the product. As such, this message is not exempt and is not acceptable.

      A 1 Reply Last reply
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      • Jennifer CarrollJ Jennifer Carroll

        Hi @karen-taylor

        The message “Another indication for Product X” is an unclear claim of product merit and an embellishment which extends beyond Section 1.5Dii of the PAAB Code “(“Materials Not Subject to Preclearance”). It accords significance to the formulary body listing the product for multiple indications. Formulary bodies have requested that coverage not be promoted in a manner that suggests endorsements for the product. As such, this message is not exempt and is not acceptable.

        A Offline
        A Offline
        Abyscat
        wrote on last edited by
        #3

        @jennifer-carroll It is a fact that provincial formularies will often expand the funding criteria for listed products during a product's lifecycle. Can you suggest language that can be used to communicate this fact in a way that does not, in your words, amount to an "unclear claim of product merit and an embellishment". Note that AskPAAB Question 71 indicates that companies may inform of a changes in formulary status.

        Jennifer CarrollJ 1 Reply Last reply
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        • A Abyscat

          @jennifer-carroll It is a fact that provincial formularies will often expand the funding criteria for listed products during a product's lifecycle. Can you suggest language that can be used to communicate this fact in a way that does not, in your words, amount to an "unclear claim of product merit and an embellishment". Note that AskPAAB Question 71 indicates that companies may inform of a changes in formulary status.

          Jennifer CarrollJ Offline
          Jennifer CarrollJ Offline
          Jennifer Carroll
          wrote on last edited by
          #4

          @abyscat

          In general, companies can provide communication regarding formulary changes as an informational “Update”/”Change”. PAAB can provide review for the overall message/context.

          E.g., “The formulary status for Drug XYZ has been updated” followed by the updated criteria.

          A 1 Reply Last reply
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          • Jennifer CarrollJ Jennifer Carroll

            @abyscat

            In general, companies can provide communication regarding formulary changes as an informational “Update”/”Change”. PAAB can provide review for the overall message/context.

            E.g., “The formulary status for Drug XYZ has been updated” followed by the updated criteria.

            A Offline
            A Offline
            Abyscat
            wrote on last edited by
            #5

            @jennifer-carroll Thanks! So, just to be clear, would the message "The formulary status for Drug XYZ has been updated" (not linked to product/therapeutic area messages) by exempt from PAAB review under s.1.5?

            Jennifer CarrollJ 1 Reply Last reply
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            • A Abyscat

              @jennifer-carroll Thanks! So, just to be clear, would the message "The formulary status for Drug XYZ has been updated" (not linked to product/therapeutic area messages) by exempt from PAAB review under s.1.5?

              Jennifer CarrollJ Offline
              Jennifer CarrollJ Offline
              Jennifer Carroll
              wrote on last edited by
              #6

              @abyscat

              “The formulary status for Drug XYA has been updated” may potentially be exempt depending on the context in which it is presented. Our PAAB opinion service is available for exempt opinions.

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