pre-NOC editorial advertising

[ALee]

A sponsor has an existing Product-A indicated for Severe Condition-X. They will eventually have a new Product-B indicated for Mild Condition-X.
Question 1: Can they produce a pre-NOC editorial campaign discussing current treatment options for Mild Condition-X without alluding to future entrants?
Question 2: Could this be seen as off-label promotion of Product-A?

[Jennifer Carroll]

Hey @andrewleeson

1. A properly executed pre-NOC editorial campaign discussing the current treatment options without alluding to future entrants and which does not suggest unmet need, could be done. In my experience, when manufacturers have submitted this sort of content in the past, it has generally been to show how the current treatment landscape falls short of needs or to showcase why a new option is required to close a gap of some sort. As neither of these are acceptable, it is generally better to exclude discussion of the current treatment landscape or at least keep in mind that substantial revision may be required. For additional information on execution see Pre-NOC Corporate/Editorial Communications and Q&A Disease awareness Pre-NOC. Keep in mind, that the editorial campaign should not contain branding elements of either Product A or future branding elements for Product B (including branding elements from other jurisdictions).

2. As this piece would fall within the scope of the PAAB Code, we will help ensure that there is no off-label promotions for Product-A when performing the review. Some things to look out for include, branding elements, and/or focusing on a particular therapeutic class or pathway that the sponsor has vested interest in.