329 - Once a patient website for a medication is PAAB approved, do the footnotes and references need to appear in the copy of the live site?
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Let us know at the initial submission stage whether the reference list will appear within the patient information piece. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece. Either way, note that we require the reference list (and annotated references) for our review of the APS content. Footnotes which are approved as part of the copydeck must appear in the piece. In fact, all APS content must always appear exactly as approved.
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Hi @Jennifer-Carroll. Our agency recently recognized that while we understand a formal reference list is not required in patient-directed tools, we could not identify the specific section of the PAAB Code that supports this. Could you help clarify where this is addressed?
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Good Morning @palanski
There is not a part of the Code that states that it’s “not required”. Per the above response “. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece.” Code section 6 (Patient Information) states “Company controlled or prepared branded patient information is information that contains non-promotional material that is consistent with, and in addition to, the Health Canada approved patient information (e.g. the consumer information section of the product monograph, patient insert, approved product labelling)” and “All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims”. While other sources may support disease understanding, they do not act as sources of evidence for promotional claims which is the case in HCP advertising and therefore requires the source of evidence to be provided to the HCP for transparency. PAAB does not discourage inclusion of reference lists within patient pieces, it is simply not a requirement of the Code.
