PAAB exemption requirements for Promotional Monograph
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Hello,
I have gone over the PAAB Guidance on Promotional Monographs and have a few questions:
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If the only changes made to the PM are applying brand colours to the headers, sub-headers, bullet points etc throughout (without using any callouts or emphasizing any sections) and wrapping it in a branded cover, would it still be PAAB exempt? If not, then-
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Could you please clarify this section-
The product monograph (PM) within the promotional monograph should be presented verbatim. It should not contain visual treatments that create emphasis not present in the PM (e.g. bolding, underlining, boxing, capitalizing, shading, colour treatments, etc.).
If we were to create a promotional monograph with colour treatments, icons etc, then are we required to have an unmodified PM included as an insert?
- Could you please clarify this section-
A promotional monograph is considered to be promotional because it contains embellishments that emphasize benefits and features of the product. Hence, indication and fair balance is required.
If the promotional monograph doesn't selectively emphasize any section, and applies the same visual treatments throughout, then does it still need fair balance included? Is it still considered a promotional monograph?
Appreciate your help in interpreting this guidance, thank you!
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Hello @supraja
It is important to consume the document in its entirety and assess the sections in which the copy is presented so as not to mix exemption criteria copy with copy for the appropriate application on acceptable modifications to a “Promotional Monograph”. A systematic approach to assess your piece should then start with the question “Is this a promotional monograph”. To answer that question, we look to the definition at the top of the document of what a promotional monograph is versus what would be considered exempt. The document states: “A promotional monograph is defined as a product monograph (PM) that has been modified by the addition of promotional elements.”. It goes on to state the common exceptions:
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A product monograph whose only modification is the insertion of blank note pages does not require PAAB review.
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A product monograph whose only modification is the non-selective addition of tabs for each heading throughout the product monograph would not require PAAB review.
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A product monograph wrapped in a simple cover (e.g. brand colours) does not require PAAB review. However, review is required if images are added (in which case the above restriction pertaining to document title would apply).
Note that the underlined part would include the brand logo and icons and would not meet exemption criteria. The PAAB review would entail ensuring the visual treatments do not create emphasis and the logo/icons are not promotional.
Now moving to part 2 of your question, the copy “The PM should be presented verbatim. It should not contain visual treatments that create emphasis not present in the PM (e.g. bolding, underlining, boxing, capitalizing, shading, colour treatments, etc.). For pages containing PM text, elements such as graphs, callouts, images can only appear in the page margins so as not to segment the PM text.” appears under the headline “The product monograph (PM) within the promotional monograph”. If we then look earlier in the document, we can see that a stipulation of being able to call the document a “promotional monograph” exists under the heading “Modifications” and states “Modifications may be based on the PM or other sources. They may be text boxes or images. Modifications should be presented in such a way as to be clearly distinguished from the PM itself. For example, callouts positioned in the margins may be used for text.”
In summary, if the PM does not meet the exemption criteria, it is subject to review to meet the standards of “Promotional Monograph”. When this is the case, coloured formatting throughout may be acceptable and callouts can occur but should be clearly separated from the PM copy itself. An unmodified PM as an insert is not required. When reviewing colour treatment, PAAB will be looking to ensure that the colour treatment does not create emphasis not present in the PM. These pieces will require the indication and fair balance. These requirements can be found in the PAAB documents “Guidance document for indication placement in advertising” and “Guidance on base fair balance level selection” mentioned in the guidance document.
Q&A Brand colours in the PM and Clinical Monographs may also help.
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Thanks for the thorough explanation, as well as for directing me to similar questions on the forum! I now understand that the modifications we have in mind would deem it a promotional monograph and require PAAB review.
You mention "The PAAB review would entail ensuring the visual treatments do not create emphasis and the logo/icons are not promotional", however, by nature, a promotional monograph is promotional, and colour treatments will certainly create emphasis not present in the original black-and-white PM. These aspects are a little unclear still (I assume the goal is to not create disproportionate emphasis), but we'll do our best to follow the guidelines and submit for review and feedback. Thank you!
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Good Morning @Supraja
The copy in quotes above refers to the “PM copy within the promotional monograph”. When we look for emphasis, we look for things like adding colour to select headings in a manner that creates emphasis that is inconsistent with the PM; selective addition of colour to copy in a manner that creates emphasis such as only colouring key words or portions of a paragraph or one clinical trial; selectively bolding copy, etc. While it’s a promotional monograph, the changes to the PM copy specifically in the promotional monograph, should not be done in a manner that creates emphasis which is not reflective of that within the actual PM. When that occurs, the piece is no longer meets the criteria outlined in the “Guidance Document for Promotional Monographs”.
In summary: Addition of colour renders the PM a “promotional monograph”. The PM copy can have colour treatment to it however it should be done in a manner that does not create emphasis (i.e. all headlines are in the brand colour pink). Selective treatment which creates emphasis would not be acceptable. If the sponsor wishes to use selective treatment, the piece would no longer meet the criteria outlined in the “Guidance Document for Promotional Monographs”.
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That answers any lingering questions I had, thank you so much for taking the time to explain!
