If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination.
The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product. The company does not have any ability to alter content if there is a comment from PAAB. We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way). We are running into similar issues with a disease and treatment video for patients produced by the same group (sponsored by us) which the sales force would also like to distribute broadly healthcare professionals as a DVD and show on their i-pad. (Again, no ability to change content). The two scenarios (newsletter and video) have similar components. Thank you so much for your guidance on this.
Generally, materials discussing drug therapy which that exist due to manufacturer (including materials generated through unrestricted grants) require PAAB review if distributed through the sales force. For a more specific response, please submit the particulars as a written opinion (see the fee schedule on our website).