598 - Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).

  • Please note that in Q273 the copy “it may be exempt if all the treatments are balanced” speaks to the references being used to support the piece, not the content within the piece. If a drug manufacturer is generating a piece directed to healthcare professionals, which discusses drug products, PAAB preclearance is required regardless of the degree of balance.