383 - We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page containing product claims? 2) Can treatment guidelines be included on the other side of a page containing the main sections of the Product Monograph of product sited in the guidelines (Dosage, Indications, Warnings and Precautions, Contraindications and Adverse reactions)?
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The statement cannot necessarily appear ‘anywhere’. PAAB reviews meaning. Context is an important determinant of meaning . For example, it is important to ensure that additional meanings aren’t attributed by the context in which the statement is placed (e.g. the statement should not be used in a context suggesting that product features promoted in the piece are the cause for the stated ‘place in therapy’ recommendation, the statement should not be used in a context attributing clinical significance to non-clinically significant claims presented in the piece…etc).In response to your other questions: generally, messages that are presented in a manner which is separate and distinct from other messages in the piece are reviewed in their own context. With this in mind, acceptable guideline statements (based on acceptable guideline sources) could be considered on the other side of a page containing product claims or fair balance. Note that it is possible that copy-specific balance be required to appear in proximity to the statement (this depends on whether that specific statement triggers the need to disclose additional information with the claim).
