Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Formulary Claims
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According to the answer to Question 519 and other guidance PAAB has published, when an advertisement includes details relating to coverage (such as formulary codes or eligibility criteria), the presentation must be complete (e.g. inclusion criteria, exclusion criteria, definitions, notes, etc.) so as not be misleading. Can you advise how a company can meet this requirement for completeness when the coverage details for a drug may be viewed as broader than the terms of market authorization for that same drug?
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According to the answer to Question 519 and other guidance PAAB has published, when an advertisement includes details relating to coverage (such as formulary codes or eligibility criteria), the presentation must be complete (e.g. inclusion criteria, exclusion criteria, definitions, notes, etc.) so as not be misleading. Can you advise how a company can meet this requirement for completeness when the coverage details for a drug may be viewed as broader than the terms of market authorization for that same drug?
Hi @abyscat,
In general, if a specific coverage criteria is broader then the product’s indication or terms of market authorization, it is considered off-label and not acceptable in advertising. We suggest calling PAAB or submitting an opinion if there is specific formulary criteria that may require further clarification.
