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  4. Clarity on RMT PAAB guidance
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Clarity on RMT PAAB guidance

Scheduled Pinned Locked Moved Guidance on Submission Procedures
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  • K Offline
    K Offline
    kshulist
    wrote on last edited by
    #1

    Hi there,
    I'm looking for a bit of clarity on the PAAB "Guidance on RMTs" document, specifically on page 4, the first FAQ. (https://www.paab.ca/Guidance_on_Risk_Managment_Tools_(September_2016).pdf),

    For context, the FAQ says:
    What if the manufacturer plans to:
    -Instruct/train drug representative to detail from the RMT during a sales call in order to make sure HCPs consume this important content?
    -Include product claims and statements of benefits in order to establish balance in the tool?
    Answer: The piece would simply be subject to all PAAB code provisions relating to APS and to standard review times.

    I have two questions. The first is, do both of those bullet points have to apply for the piece to not be considered a RMT? For example, say the piece is intended to be detailed to HCPs by the reps, but they do not plan to include any claims/benefits - is it still subject to all code relating to APS or could it be submitted as a RMT?

    My second question is related to the text "during a sales call" - what if the rep specifically sets up a separate RMT-related call (i.e., not a sales call), is this case, is the piece still subject to all code relating to APS or could it be submitted as a RMT?

    Any help would be much appreciated! Thank you very much!

    Jennifer CarrollJ 1 Reply Last reply
    0
    • K kshulist

      Hi there,
      I'm looking for a bit of clarity on the PAAB "Guidance on RMTs" document, specifically on page 4, the first FAQ. (https://www.paab.ca/Guidance_on_Risk_Managment_Tools_(September_2016).pdf),

      For context, the FAQ says:
      What if the manufacturer plans to:
      -Instruct/train drug representative to detail from the RMT during a sales call in order to make sure HCPs consume this important content?
      -Include product claims and statements of benefits in order to establish balance in the tool?
      Answer: The piece would simply be subject to all PAAB code provisions relating to APS and to standard review times.

      I have two questions. The first is, do both of those bullet points have to apply for the piece to not be considered a RMT? For example, say the piece is intended to be detailed to HCPs by the reps, but they do not plan to include any claims/benefits - is it still subject to all code relating to APS or could it be submitted as a RMT?

      My second question is related to the text "during a sales call" - what if the rep specifically sets up a separate RMT-related call (i.e., not a sales call), is this case, is the piece still subject to all code relating to APS or could it be submitted as a RMT?

      Any help would be much appreciated! Thank you very much!

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

      Good Morning @kshulist

      The two bullets are not both required in order to be subject to the Code. If the rep is using the tool to detail, or claims/benefit copy is included, it would fall under the scope of the PAAB Code. Paragraph four on page one of the above-mentioned document states:

      The purpose of RMTs is to convey important identified risks, important potential risks, and missing information about a manufacturer’s products. They do not contain claims of benefit as these tools are created solely with the aim of minimizing / managing / mitigating risk. Although distribution of such tools need not be in response to unsolicited requests, they are NOT intended or destined for promotional activities/uses and may not be used in such ways unless they undergo standard PAAB approval.

      Labelling the call an RMT-related call would not be sufficient to allow for detailing of the RMT tool. Please see Code section 1.8d.

      K 1 Reply Last reply
      0
      • Jennifer CarrollJ Jennifer Carroll

        Good Morning @kshulist

        The two bullets are not both required in order to be subject to the Code. If the rep is using the tool to detail, or claims/benefit copy is included, it would fall under the scope of the PAAB Code. Paragraph four on page one of the above-mentioned document states:

        The purpose of RMTs is to convey important identified risks, important potential risks, and missing information about a manufacturer’s products. They do not contain claims of benefit as these tools are created solely with the aim of minimizing / managing / mitigating risk. Although distribution of such tools need not be in response to unsolicited requests, they are NOT intended or destined for promotional activities/uses and may not be used in such ways unless they undergo standard PAAB approval.

        Labelling the call an RMT-related call would not be sufficient to allow for detailing of the RMT tool. Please see Code section 1.8d.

        K Offline
        K Offline
        kshulist
        wrote on last edited by
        #3

        @jennifer-carroll Thanks very much for clarifying!

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