Discussing 'unmet needs' in a branded piece

[kshulist]

Hi there,
I gather from Question 99 (https://forum.paab.ca/topic/247/99-does-paab-have-specific-rules-regarding-pre-noc-communications?utm_source=chatgpt.com) that you may discuss unmet needs in a unbranded sense as long as you are not being disparaging to other treatments nor pointing to a specific treatment.

My first question is whether you can discuss unmet needs in a branded sense? My assumption would be (following the logic of Question 99) that you cannot discuss unmet needs in a branded sense because the branding would inherently point to a specific treatment (even if you are careful with the copy). Is that correct?

My next question is could you discuss unmet needs in a branded sense if the drug is the first ever (and only) treatment for a condition? In this case, there was a clear unmet need (there were no treatments), now there is a treatment option, and there are no other treatments to disparage or 'point away from'.

Thanks so much for your help!

[Jennifer Carroll]

Hey @kshulist

Correct. You cannot speak to unmet need in a branded context.
Even if the drug is the first treatment for a certain condition, discussing “unmet need” suggests that the product addresses that need in an absolute manner. There are still ways to convey treatments where no options were previously available without stating “ need”. PAAB may be able to assist with the direction of messaging. Please reach out for additional assistance in a forum that allows for more specifics to be shared.