Unbranded APS on clinical study summary
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Hi Jennifer. I would like clarity on unbranded APS that serve to provide a balanced overview of a clinical study. If the clinical study involved the sponsored product, does this necessitate the piece to be branded with product name/logo - if it meets all other requirements of the PAAB code? I would understand that the piece would be reviewed in a promotional sense in light of the product, but as far as my understanding of the code, there is no requirement to 'brand' the piece. This also then triggers requirement for fair balance, etc. By that logic, for e.g. the study could be involving 3 of the sponsor's products, would the APS then need to be branded with all 3 brand names/logos?
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Hi Jennifer. I would like clarity on unbranded APS that serve to provide a balanced overview of a clinical study. If the clinical study involved the sponsored product, does this necessitate the piece to be branded with product name/logo - if it meets all other requirements of the PAAB code? I would understand that the piece would be reviewed in a promotional sense in light of the product, but as far as my understanding of the code, there is no requirement to 'brand' the piece. This also then triggers requirement for fair balance, etc. By that logic, for e.g. the study could be involving 3 of the sponsor's products, would the APS then need to be branded with all 3 brand names/logos?
Hello @mef
To answer the question we should be clear that “branded” and “branding elements” might be a point of confusion in the question. A clinical trial summary produced by the sponsor for a trial with their product is inherently branded. They have a vested interest as it is their product. This is different from “branding elements” such as the brand logo (or brand colours, images, etc.).
Code section 2.2 states: “In all APS for pharmaceutical products, the brand or trade name, the nonproprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible. For example, (Pr)ARBACE
(Arbasartin Sodium). The Federal drug schedule is not required to be disclosed for non-prescription products”. This does not require that the brand logo be presented on the piece. If the study included three of the sponsor's products, the piece would be required to meet the standards outlined in section 2.2.The fair balance requirements are a separate issue that requires that the indication and risk to benefit are presented in any piece with a product marketing claim. It seems highly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three products.
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Hello @mef
To answer the question we should be clear that “branded” and “branding elements” might be a point of confusion in the question. A clinical trial summary produced by the sponsor for a trial with their product is inherently branded. They have a vested interest as it is their product. This is different from “branding elements” such as the brand logo (or brand colours, images, etc.).
Code section 2.2 states: “In all APS for pharmaceutical products, the brand or trade name, the nonproprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible. For example, (Pr)ARBACE
(Arbasartin Sodium). The Federal drug schedule is not required to be disclosed for non-prescription products”. This does not require that the brand logo be presented on the piece. If the study included three of the sponsor's products, the piece would be required to meet the standards outlined in section 2.2.The fair balance requirements are a separate issue that requires that the indication and risk to benefit are presented in any piece with a product marketing claim. It seems highly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three products.
@jennifer-carroll said in Unbranded APS on clinical study summary:
ly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three
Thanks for the clarification!
