Clarity on RMT PAAB guidance
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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!
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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!
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.
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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.
@jennifer-carroll Thanks very much for clarifying!
