We understand the guidelines regarding what can and can't be included in a PM comparison of several products. This question is limited to the products included in the comparison. Let's say the table is a comparison of a specific drug class with the same indication and that there are about 10 products on the market. What does PAAB require as support that some products do not need to be included in the table? What are the guidelines to determine what products need to be included in the comparison and what products can be excluded? Or is at the discretion of the manufacturer developing the table?
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Posts
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Product Monograph Comparisons -
NOCc and Guidance on Duration of Clinical Trials@jennifer-carroll Thank you.
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NOCc and Guidance on Duration of Clinical TrialsHello Jennifer. What are the implications of an NOCc on the use of extension studies in advertising? This refers to the "Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising."
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PAAB logo on DTCA@jennifer-carroll
Thank you for your quick reply! In the 'no objection' letter, there seems to be an expiry date. From what I understand of these types of opinion reviews, there is no expiry. Can you please clarify? Thank you. -
PAAB logo on DTCAHi. We've used both PAAB and ASC to provide an opinion service for DTC pieces. ASC does not require their logo on these pieces (although they recommend it). Does PAAB require their logo and if so, why? Thank you.
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Product Monograph situationWe would like to get your thoughts on a potential situation and how it could affect marketing communication tools.
Product A: no existing indication, completely new to the market. Product B: Has an NOC for indication X.
Scenario: Single-use of Product A combined with ongoing or longer use of Product B is granted NOC for indication Z (i.e. PM for Product A) ahead of Product B receiving an additional indication for Z (PM for product B). Note that both products are undergoing Health Canada review for indication Z with the exact same data/ studies. The timing, however, may not be simultaneous.
Questions: (1) Can the logos of Product A and B be used on promotional pieces? (2) Can we callout the dosing of Product B explicitly? (3) Can information on Product A and B have equal prominence within pieces? (4) Given that product B already has an indication, an HCP and patient website already exists, can we send HCP/patients to Product B’s website (in a specific location) to get information on indication Z? (5) What are key considerations with respect to promotion?
Thank you.
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PAAB Code 3.2.3@jennifer-carroll
Thanks Jennifer. Given that the product is not yet authorized for the indication being studied(pre-NOC) AND the studies are still ongoing, could we not create an APS that refers to these ongoing studies? Eg. Objective, Design, number of patients etc. The code seems to state this.