439 - Upon reading the PAAB guidance it appears that we are able to put general disease information and general symptoms into a Patient booklet that is distributed to patients after they have been prescribed the drug. Is this the case?

[Jennifer Carroll]

Non-promotional disease information can be considered in product-branded patient information provided the disease information falls within the limitations of the product’s indication per the Terms of Market Authorization (TMA). The disease information should be supported by authoritative sources (e.g. guidelines, medical textbooks) or Standard Setting Organizations. Additional caveats that come to mind include:

• not emphasizing a particular symptom or segment of symptoms unless this emphasis is supported by the TMA (i.e. it’s best to provide a list of all the key symptoms from the authoritative source as long as they fall within the approved indication).

• not presenting disease consequences relating to the treated disease (e.g. heart attacks, stroke, or death in a piece for an antihypertensive product) unless those consequences appear in part III of the TMA (in which case the information should be presented in the manner which reflects the context and level of emphasis in the TMA).

For example, patient information often includes discussion of disease triggers in the context of lifestyle tips about how to avoid those triggers. This can be considered provided the discussed disease is indeed the disease the product is indicated to manage. This is NOT a complete list of the types of disease information which can or cannot be considered in branded patient information. We’ve merely provided a list of the issues which appear to come up most frequently when reviewing disease information for branded pieces. We remind everyone that there is a “Guidance on Branded Patient Information” resource available on the PAAB website.