We plan to send out a letter to pharmacists to inform them of a change in the product package (design of the blister pack). The announcement would not include any product claims. I have reviewed the Distinction document, PAAB Q&A and Forum but don't find any direction on this type of communication. The Guidance on which materials require PAAB review says "Is there discussion of drug therapy or content relating to drug therapy?" In this scenario, I think the answer is no and therefor exempt. If that's the case, for clarity, can the announcement include the product indication and still be exempt?
Jennifer Carroll last edited by
The inclusion of the indication would prompt, at minimum, lowest level fair balance and would not be considered exempt.
If exemption is the goal, we suggest submitting for an exemption opinion (see Exemption Request Policy and Procedure). This will allow the reviewer to assess the content and determine if the piece is exempt, or advise on changes to make the piece exempt. The exemption criteria require that there is no therapeutic mention or promotional marketing message about the product. It’s possible to still have promotional marketing messages even if they are not therapeutic messages (i.e. labeled blisters to help track dosage).