Off-Label Self Promotion - What to do

[deuce64]

Here's a good one:
i was recently speaking with a European marketing manager who was describing the wonderful outcome of his recent tradeshow, when he started describing a seminar that he held. He described a seminar in which he connected 2 training surgeons with other surgeons attending the congress, to learn about a technique that the trainers had published. Unfortunatly, in my opinion, this technique is not on-label. it may also not be entirely off-label either, but my gut tells me that our company should not have held such a seminar. As such, i'm now faced with the tricky decision of what to do. obviously some policy must be announced that forces regulatory review of all trade show materials. (we already look at brochures and marketing fliers etc, but this is a new one). should there be a CAPA? do i have to report? to whom? is there a FSCA notice to the attendees?
Keep in mind this is an EU only congress.
thanks for your thoughts.

 

[Ronen E]

A CAPA sounds like a good idea. You don't want it to ever happen again.

The subject use is now on-label IMO, unless you take all reasonable measures to "undo" the seminar's consequences.

 

[deuce64]

CAPA is a definite.
As for your second comment, can you elaborate?
thx

 

[Ronen E]

CAPA is a definite.
As for your second comment, can you elaborate?
thx

I can't really elaborate without being in the loop. Basically you have to make sure that this use will not be exercised as a result of the seminar given. Investigate who attended and what they took away from the seminar, understand whether they've already implemented anything and try to negate whatever you can, or at least clarify to all stakeholders that you don't endorse that use, that this was a slip, and that anyone practicing this use is taking full responsibility (as with any "usual" off-label use).

If the use already occurred, study the consequences and decide what can and needs to be done. You might not have a choice but to treat this use as intended, with all the consequences.

Sorry,
Ronen.

PS This is not legal advice, and perhaps you should seek one in parallel - especially if the use has significant consequences that can't be fully undone.