331 - What are the rules/regulations of non-pharmacological aspects on branded pieces. For example are questions about symptoms acceptable?



  • I am unsure whether the question refers to HCP branded content or patient branded content. I am also unclear what type of symptom data is presented and in which context. For example, are we talking about which symptoms are addressed through certain non-pharm tips, are we talking about differential diagnosis, or are we talking about symptoms of the condition in general?

    I'll therefore respond in broad terms highlighting what, in my experience, clients tend to be most surprised about when dealing with disease information. This is not meant to be a comprehensive list of all potential pitfalls. The provisions discussed relate to PAAB code s3.1. All information in a branded APS is required to fall within the limitations of the TMA. Clients are sometimes surprised to learn that disease content is restricted by the featured product's authorized indication. Also, note that specific symptoms which are called out in APS should generally be identified in the TMA. For HCP adverting, clients are sometimes surprised to learn that some disease information presentations trigger the need for quantification of the drug's effect on the highlighted disease issue. For example, the message "72% of patients with allergic rhinitis say that their symptoms are affecting their quality of life" would require inclusion of clinical trial data (meeting all relevant PAAB code requirements) which communicates the extent to which the promoted brand improves QOL vs the active or inactive comparator.


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