@charlton
The proposed plan does not necessarily contravene the PAAB Code provided the messaging in those advertising materials are within the limitations of the product’s label. However, there is more than the PAAB Code to consider here. While the materials may be designed in a manner that meets the applicable standards of the PAAB Code, use of those materials in the proposed context may trigger activities/discussions that fall within the scope of federal regulations despite falling outside of the PAAB Code’s scope. Consequently, it may be prudent to pause and consider whether this proposed approach fits the company’s risk profile from the perspective of broader federal regulations. For example, it may be challenging to manage risks related to the conference context. As is always the case, sales reps operating the booth must not discuss off-label uses (even in response to requests for such information as this reactive discussion would be taking place in a promotional context that is subject to federal advertising regulations). The more challenging nuance, relating to this case specifically, may be that it would be difficult to direct attendees to the medical booth without appearing to have intended to trigger that off-label discussion all along. This would likely disqualify the off-label discussion from the federal advertising regulation exemption relating to “unsolicited” requests.
Additionally, please be reminded that in-person branded booths should not include or be linked in some manner, to unbranded editorial material, exempt material, press releases, learning sessions, etc. The same principles apply for digital conferences with digital linkages, targeting, etc. as well. Please see our Digital conferences document for other considerations.
