FDA to Study ‘Overwarning’ in DTC Ads

FDA has proposed a new “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads” that is intended to research regulatory requirements for fair balance and the brief summary. Specifically, the agency wants to know if repeating warnings in the Important Safety Information (ISI) section of DTC ads and in the brief summary gives consumers warning fatigue, according to an agency notice. “Overwarning is the concept that individuals are exposed to so many warnings in the course of daily life that they are less likely to pay attention to any one particular warning,” it says. “In terms of presenting risk information, detailing too many risks may lead consumers to discount all risks, or miss the most important risk information. Similarly, habituation follows when readers see the same warning repeatedly. Upon seeing a particular warning repeatedly, consumers may cease to pay attention to it.