292 - Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!
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The core principle is that a claim should not rely on mice-type to save it from being misleading. The issue is potentially broader than the indication or dosage (hence the broadening in the new code). For example, just yesterday I saw the claim "Now covered as a general benefit" in an APS intended to be used across Canada. Nothing out of the ordinary here right? Well, the claim was cross-referenced to "Covered as a general benefit in Province X, covered with special authorization in Provinces A, B,C, and D". This has nothing to do with indication and dosing, but the principle in s3.1.6 should still apply.
