According to new FDA draft guidance, promotional material can be misleading even if specific individual claims or presentations aren't misleading. For example, if music plays over a voice-over of fair balance/adequate provision – the agency feels that can be misleading. Similarly, "discordant" images of happy patients (i.e., running through a field of daisies for an allergy medicine) while the risk information is detailed could also be viewed as violative.
Pretty subjective proposition.
The draft guidance (which can be found here) also introduces a new term, "net impression." DDMAC will now consider the “net impression” of consumer ads and physician detailing materials to determine if a piece conveys accurate information about a particular product.
In other words, rather than creating brighter lines so that industry can be in compliance, the agency is opting for even greater regulatory ambiguity.
Not good.
Pretty subjective proposition.
The draft guidance (which can be found here) also introduces a new term, "net impression." DDMAC will now consider the “net impression” of consumer ads and physician detailing materials to determine if a piece conveys accurate information about a particular product.
In other words, rather than creating brighter lines so that industry can be in compliance, the agency is opting for even greater regulatory ambiguity.
Not good.
