NOC/c disclosure in HCP materials

  • Hi, I am requesting clarity on the NOC/c guidance document issued by PAAB. For a piece with multiple indications, some NOC and some NOC/c, the guidance is the include the boxed copy "at first mention of the therapeutic category for which the NOC/c indication exists."

    If we took the provided patient example (two distinct indications in multiple myeloma), and applied it to the cover of a detail aid, in most cases, the headline would disclose the condition and indication statements (for the NOC and the NOC/c indication) would be required on the cover.

    Would the box go in the top right, or with the NOC/c indication? Does "at the first mention of the therapeutic category" in the guidance document mean "the top right corner of the spread that first mentions the therapeutic category" or actual "at the first mention", as in, with the headline somehow?

    Further, the statement gives no leeway to differentiate which indication(s) has/have NOC/c, is that correct?

  • Good morning @Username, sorry for missing this question – let's see if we can still help you with this

    It's important to not confuse the directions for patient pieces and HCP detail aids. The situation you are describing in paragraph two appears to be mixing the directions for patient and HCP. Patient material should be non-promotional information. In the situation where there is a combination of multiple NOC and/or NOC/c’s which cross the same therapeutic category, the copy should be clearly limited to the NOC population. If the copy is broad and could encompass the NOC/c to some degree, the NOC/c would be required to be presented in the piece.

    For the question in paragraph three, “at first mention of the therapeutic category” refers to pieces where there may be NOC and NOC/c in different therapeutic categories. For example NOC for RA and NOC/c for UC. If the piece doesn’t mention UC until page 3, the NOC/c disclosure is not required until that page as that is first mention.

    In a situation where you have one NOC and one NOC/c within the same therapeutic area and presented together upfront, the first presented option within the document Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc should be followed. For example, the complete boxed NOC/c copy from the cover should be presented.

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