Unbranded Materials - Linking PAAB-approved and PAAB exempt materials together
-
When developing materials for an unbranded, disease-focused, HCP-directed campaign, is it acceptable to link PAAB-approved APS with PAAB-exempt materials, and vice versa?
For example, would we be able to have a PAAB-approved email direct to PAAB-exempt website? Would a PAAB-exempt website be able to host unbranded, PAAB-approved APS?
-
PAAB does not approve exempt materials. Our review service provides an opinion on whether submitted material is exempt from review. As such no proper review against the PAAB code and supporting evidence was undertaken with the exempt materials. When exempt material is linked to unbranded PAAB reviewed APS, the exempt file would be subject to PAAB review because of the linkage. The exempt material would be reviewable as unbranded, editorial APS per section 7.5 as well as applicable codes sections with respect to substantiation for the claims within.
In the example presented, the previously exempt website would no longer be exempt and should be submitted for full review. Similarly, the exempt website may not host PAAB approved unbranded APS as the linkage would render the exempt website reviewable.