Unbranded HCP targeted disease information materials which meet all of the following criteria are exempt from PAAB preclearance:
- makes no mention of medication by name, class, or category
- does not discuss or allude to medication or to medication issues (e.g. adherence, societal cost burden of drug coverage…)
- does not linked to product/class/category advertising in any way (e.g. contextually, proximity, through hyperlinks, appearance…)
It’s easy for you to tell whether there is mention of a product. Where clients sometimes struggle is in determining whether the piece relates to a drug issue or whether the piece somehow links to drug advertising. Our written opinion service can help you determine that for any particular tool (see fee schedule on our website).
Please note that basing an HCP piece on DTC materials does not, in and of itself, render a piece exempt. Content which has no (or limited) meaning to consumers may take on more concrete meaning to a specialized audience such as HCPs.
Also note that utilizing the same creative concept across multiple pieces essentially creates a link between those pieces. Whenever linking separate materials/activities, always pause to examine whether the linkage would change the regulatory status of those materials. PAAB could also help you with that assessment through our opinion service.