Level of fair balance required for guidelines claims
We are interested in making a branded HCP web banner ad that presents a guideline recommendations for our medication. We note that PAAB's resources for fair balance selection stipulate that place in therapy claims require high-level fair balance. Unfortunately, this requirement would make it practically impossible to make these web banner ads, due to the space required for high-level fair balance.
Recently, we came across a journal ad with only low-level fair balance that has the following callout: "Now available in Canada with an indication for us in the second-line setting in DiseaseXXX...". This journal ad cites both the PM and the treatment guidelines as references for this claim, but does not mention the name of guidelines in the body copy (only in the references), nor the word "recommended". However, we note that the mention of "second-line" is leveraged from the guidelines, and not the PM.
We are wondering if PAAB has amended the high-level fair balance requirement for place in therapy claims (or similar product claims from treatment guidelines). Do these requirements change if the name of the guidelines or the word "recommended" are mentioned in the body copy? For the purposes of a banner ad that would only be able to fit low-level fair balance, which product-specific guidelines claims can be used?
Thank you in advance!
Jennifer Carroll last edited by Jennifer Carroll
PAAB has not amended the requirements for highest fair balance for place in therapy claims when based on consensus guidelines. Our [guidance on base fair balance level selection](https://www.paab.ca/resources/guidance-on-base-fair-balance-level-selection-and-placement/italicised text) and placement remains in effect. While we do not know the complete details of the journal ad example noted, the provided callout “…with an indication for use in the second line setting…” appears to be for an indication-based clinical use setting claim as opposed to a guideline-based place in therapy status recommendation claim. It is possible to have an indication that provides its clinical use setting. E.g. “Drug X is indicated for treatment of condition Y after failure of drug Z. The indication places use of drug X in a second line setting in this case. Please note that clinical use settings differ from recommendation status claims from consensus guidelines, e.g. Guideline A recommends Drug X as second line therapy. The indication may be similar or concur with a consensus guideline recommendation. However, the clinical use claim can be substantiated by the product monograph indication itself. A guideline reference would be optional and would not be a determinant for acceptability of the claim or its fair balance. In the absence of any other claims beyond the indication, lowest level fair balance would only be required in those cases. For a small space ad, guideline status recommendation claims would continue to require highest level fair balance.
Depending on the dimensions of the banner and the number of warnings / precautions associated with the product, it might be feasible to use middle level fair balance to direct the HCP to highest level fair balance. Also consider whether the platform can accommodate an automatically rotating multi-frame banner ad or if more than one contiguous banner can be purchased such that they are concurrently visible.
As a courtesy, the following message structure may also be a consideration as it would qualify for lowest level fair balance: “Drug X is included within the Guideline ABC. Click here to learn more”.
@jennifer-carroll Thank you for your helpful response!