356 - Could you please clarify the response to Question 232, as it seems to imply that there is no such thing as a true "unbranded" piece. The nature of the Rep-HCP interaction is such that unbranded and branded discussions frequently take place in the same call. It was our understanding that as long as there is a clear transition/distinguishing between unbranded and branded content, that pieces are reviewed separately without assuming linkage.

  • Question 232 asked whether product branded and non-product branded editorial materials should be discussed in the same sales call.

    The fact that the regulations for product branded pieces and editorials are very different lies at the core of the answer to question 232. All content in a branded piece is reviewed to ensure it is within the limitations of that specific product's TMA (per PAAB code 3.1), while an editorial is reviewed under the provisions in PAAB code section 7.5. It is possible that disease or product class statements in an editorial exceed the limitations of the sponsor product's TMA. As such, a link between that product and the editorial content might contravene section 3.1 of the PAAB code and section 9.1 of the Food and Drugs Act. The code also identifies the most common linkage factors: proximity, appearance, sequence, and context. Detailing editorial content which was not reviewed to ensure consistency specifically with drug X's TMA in the context of a sales call in which the rep details about drug X is not that different from placing the editorial content (containing off-label info) in a different section of the product's branded piece. You've created a link whether you have a clear transition or not.

    There is indeed such a thing as a true unbranded piece, provided we consider the linkage principles and ensure that we don't link branded and non - branded content.