173 - Do personal (i.e. one to one, not mass generated) emails to HCPs announcing a product is "now available" need PAAB pre-clearance review? May such emails that mention a product also include brief mention of the general indication, disease state or therapeutic use? Thanks!

  • No, PAAB preclearance is not required for any piece containing only the drug name and the claim "now available". This is true whether the same piece is sent to one HCP or many HCPs. However, adding anything else (e.g. the indication, disease state or therapeutic use) renders it PAABable. Additional related notes: Situations where the piece is provided to an individual in response to a request for information that has not been solicited in any way is exempt from pre-clearance. It appears unlikely that an HCP requests a piece containing the message "Now available" and the product indication. Note that simply personalizing the greeting line (i.e. Dear Doctor John Doe) does not render the piece exempt for PAAB preclearance when the intent is to send the core message to multiple HCPs.