In addition to the prior posts noted by Lin, other resources include past FDA and industry presentations at conferences like the DIA Advertising and Promotion Regulatory Affairs conference. Yes, the same regulatory rules apply for promotional and scientific content, but exhibit halls do pose unique situations like booths with multiple sections (e.g., commercial, pipeline, medical affairs, and corporate/HR areas) all in the same footprint. These multi-purpose booths highlight the importance of the Regulatory role in not just review of the planned commercial materials, but in the entire booth planning effort to include review of ANY materials being displayed - no matter what section of the booth; plans for staffing of each area; and how to handle questions that might arise (e.g., if a question about an investigational product or unapproved indication is asked by a visitor in the commercial section of the booth - how do you train the booth staff to appropriately deal with it?).
Importantly, being physically present when the booth is set up is a best practice because review of content prior to a show never replaces the actual physical assessment. Things like sight-lines and physical barriers between commercial and pipeline sections never quite appear the same in person as you may have reviewed prior to the convention. Many regulatory staff in the promotional role also will check each display to confirm it was the version approved in your MLR process. You'll be amazed at how often an incorrect version of a banner or display is delivered for display and its important to fix these before the exhibit hall opens.
Another key function once the exhibits open is to check out your competition and how other industry booths display things. There is so much variability from company to company and it can be very educational to see the variety - trust me, your company's marketing folks will be looking and bringing those ideas back to you for future conference exhibits!
As for boxed warning products - I have seen such products on display with "reminder-like" banners despite the fact the reminders are not allowed by regulation. The work-around is often a line of content on the banner that directs the user to "See booth staff for Important Safety Information" or something similar. Personally, I think this isn't appropriate, but I've seen it done and FDA has not taken enforcement action (at least in recent memory) for such displays.
Lastly, talking with others in the promotional regulatory role in forums like this and in-person to share experiences and ask questions is a very important part of learning. That diversity in experiences and in perspectives really makes a difference!
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Glenn Byrd, MBA
Chair, RAPS Board of Directors
United States
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Original Message:
Sent: 03-Sep-2022 11:37
From: Anonymous Member
Subject: Trade show/conference booth review
This message was posted by a user wishing to remain anonymous
Hello.
As a regulatory reviewer of promotional materials, where can I find some resources on the best way to approach the review for compliance of a trade show/conference booth? I know that generally the same rules apply regarding on-label promotion, fair balance, etc. - but is there any information specific to this kind of promotion? More specifically, is there anything I can review regarding how companies are presenting material on products with a boxed warning at these kinds of events?
I appreciate any direction you may be able to provide.
Thank you!