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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.
Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).
Please note that in Q273 the copy “it may be exempt if all the treatments are balanced” speaks to the references being used to support the piece, not the content within the piece. If a drug manufacturer is generating a piece directed to healthcare professionals, which discusses drug products, PAAB preclearance is required regardless of the degree of balance.
We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?
The PAAB may consider correspondence between the manufacturer and Health Canada when those correspondence clearly indicate Health Canada approval. When this cannot be determined to be the case, PAAB may need to contact Health Canada directly on behalf of the sponsor in order to confirm approval of the referenced DOF. Note that submission as part of the NDS does not in and of itself confirm that the content has been approved by Health Canada.
A disease-state piece includes mention of treatments in a balanced manner. It is distributed to consumers as a Consumer Brochure and technically exempt. Can this same piece be distributed to HCPs, or would it have to be revised to meet Editorial APS requirements? Does the content and/or level of detail dictate this?
Distribution of a piece which discusses treatment options to healthcare professionals, would require review under the PAAB code. The copy would be reviewed to ensure that it meets editorial APS requirements (PAAB Code section 7.5). Please note that “Consumer Brochures” are not considered exempt from PAAB review as they do not fall under the PAAB code (they are outside of the scope of the PAAB code). The PAAB does offer an advisory opinion on consumer brochures based on Health Canada policy documents. The following link provides the roles of the various regulatory bodies within Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents/advertising-preclearance-agencies-health-product.html
Will PAAB approve MOA comparison around selectivity in an unbranded leave behind - content is not from individual TMAs but from recent post-NOC invitro peer reviewed paper?
The description of a product’s MOA must be consistent with and within the limitations of the current Terms of Market Authorization. See Ask PAAB responses to questions 512 and 309 for further details. We caution that unbranded advertising must contain objective, balanced and scientifically rigorous information with no emphasis on information specifically about the sponsor’s product. Selectively choosing a comparison/topic which favours the sponsors drug is not acceptable in unbranded advertising. For more specific information about the reference in question, we suggest submitting this information for an opinion (see the fee schedule on our website).
For non-prescription marketed health products, is it a requirement to include a product's DIN or NPN on an advertisement/promotional piece directed at a healthcare professional?
No, the DIN or NPN are not generally required.
We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.
For place in therapy and treatment goals we look first to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. (s3.2) In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health professional organization representing this therapeutic area.
In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice. A letter from the recognized Canadian health professional organization for the particular therapeutic area is required to clearly support that the international guidelines are endorsed and more widely used by Canadian HCPs than the recent American guidelines (i.e. An official statement from the organization (not a personal letter from a KOL) on official letterhead demonstrating that it has been vetted by the entire group).
With respect to off-label content, guidelines cannot be used to support advertising content which extend beyond a product’s monograph, even in unbranded advertising. Off-label uses should not be mentioned.
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