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311 - If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?
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Disease info exceeding the indication may not appear in a product branded piece (even disease content is restricted by the authorized indication). In an unbranded piece, disease content in the context of discussion of product class/category should be within the TMA of at least one of the products within that particular class/category. Such outcomes must be discussed in a manner which is separate & distinct form drug therapy.
