Use of guideline criteria in a promotional branded piece
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Hi, I needed some clarity on incorporating Canadian guideline criteria for a specific disease state and if that can be included in a branded piece. For example, if we are stating that the guideline definition or criteria for reaching optimal benefit from different treatments is X,Y,Z and then on another page we compare our drug study results against some of that criteria - why would this not be allowed? Our intent is not to imply that we can achieve ALL of the criteria by clearly stating that is from the guidelines, and then later presenting our specific drug results (based on acceptable gold standard RCTs) which is visually separated, etc. What if we added a disclaimer or some statement to emphasize that this does not have any product implications under the guideline criteria? Thanks in advance.
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Hi, I needed some clarity on incorporating Canadian guideline criteria for a specific disease state and if that can be included in a branded piece. For example, if we are stating that the guideline definition or criteria for reaching optimal benefit from different treatments is X,Y,Z and then on another page we compare our drug study results against some of that criteria - why would this not be allowed? Our intent is not to imply that we can achieve ALL of the criteria by clearly stating that is from the guidelines, and then later presenting our specific drug results (based on acceptable gold standard RCTs) which is visually separated, etc. What if we added a disclaimer or some statement to emphasize that this does not have any product implications under the guideline criteria? Thanks in advance.
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@mhe said in Use of guideline criteria in a promotional branded piece:
ed some clarity
And happy holidays
Hello @mhe
Good question. Basically, all copy in a branded piece has implications for the brand. When you present the definition/criteria for “optimal benefit” you are suggesting that the product gets patients to “optimal benefit”. This is likely not substantiated as the clinical endpoint in the study was probably not “optimal benefit”. Claims, both direct and implied, must be supported by statistically significant findings from a well designed, published study.
With respect to adding a disclaimer, it is not sufficient to state or imply claims and then use a disclaimer to off-set them. That which cannot be supported should not be stated or implied.
Happy Holidays!
