APS discussing diagnostic test
-
Hello PAAB,
If a diagnostic test is required to determine eligibility for a drug, and we create a leave behind for HCPs explaining what the test is, how to order it, information on testing centres etc
- Either without mentioning the drug name at all, and not having any branding elements tying to the drug
- Or mentioning the drug name in a non-promotional, informational sense, also sans branding elements
Would such a piece be PAAB-exempt in one or both scenarios? Thanks for your guidance!
-
Good morning @supraja
An unbranded leave behind outlining a diagnostic test that is not exclusive to drug treatment and is part of the natural course of diagnosis and is being used as a standalone piece, may be considered exempt if it is limited to diagnosis (i.e. does not make mention of treatment or suggest treatment as a result of the test). Detailing/distributing this piece with branded content would render it subject to review (linkage principles). In the context of a branded piece and/or “mentioning a drug name in a non-promotional” context, the piece would not be exempt.
-
@jennifer-carroll Thanks very much, this is helpful!
