601 - I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B, with no additional information/limitations. It is known that Product-X also targets receptors D & E, although this information does not explicitly appear in the TMA (as it is not intended to be a repository of product information). Why would this additional information not be allowed under s3.1? We have seen s3.1 interpreted differently when applied to different sections of a TMA (eg. MOA has a highly conservative approach whereas other sections have greater latitude). Thank you.
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For the benefit of the other readers, I presume you are referring to Q&A 512. A drug’s MOA is an objective and intrinsic pharmacological property of the drug. It requires more than a couple of in vitro studies and/or review papers to support it. Generally, such claims are required to be supported by the TMA as discussed in the following PAAB tip document:
https://secure1.paab.ca/Marketing_Benefit_Claims_-_June_22.pdf
Sources like authoritative consensus guidelines or medical textbooks can be used to support pharmacologic classification. Additionally, they may be considered to elaborate on the existing mechanisms in the TMA where there is ample alignment among various medical texts and guidelines, but a detailed presentation of the MOA from those sources would conflict with a product monograph which states that the “the exact mechanism of action is unknown”. Thus in cases like Q&A 512, the TMA would generally require updating prior to consideration of a more elaborate MOA presentation. -
Re: [601 - I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B](with no additional information/limitations. It is known that Product-X also targets receptors D & E)
Hello, could you please provide clarity regarding a product's MOA presentation in an unbranded editorial piece. If Drug X targets receptor A along a pathway as mentioned in the TMA, and it is now well-established through clinical papers that it also targets receptor B and C (although not in the TMA), can this be discussed in an editorial if there is no emphasis on any one individual receptor/pathway, and all are discussed with equal balance? Would it make a difference if there was another competitor product in the same category which targets all receptors A,B and C?
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We’ve repositioned this question under 601 as it’s an add on question and therefore should be presented in that context.
Note that “product MOA” and “unbranded” do not go together as presenting the MOA of a product would make it branded. If you mean that you would like to create an unbranded piece about the MOA of a drug class of products (e.g. DPP-4i, PARPi, PD-1 receptor inhibitors etc.) the presentation is still required to be consistent with the product monographs. If the pathway exists in at least one of the TMAs in the drug class, it can be discussed in an unbranded class MOA presentation in a fair and balanced manner.
Additional support can be found in the resource Pre-NOC Corporate/Editorial Communications.
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@jennifer-carroll Thank you !
