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.
