Testing Fair Balance
It is difficult to empirically test if a DTC ad meets the FDA’s definition of fair balance, because the agency does not state specific requirements. However, our study collected several pieces of data and developed a four-level classification scheme that sheds new light on how well DTC TV ads might or might not be meeting FDA guidelines.
1. Lawbreakers are those ads that do not meet the fair balance requirement. No side effects are listed if benefits were included.
2. Bare minimum will potentially not raise too many flags with FDA. Some side effects are listed, but less than 10% of ad time is given to risk information.
3. Main pack includes one or more features that increase the visibility of risk and more than 10% of ad time is risk information.
4. Proactive is the safety-oriented approach, first used by Johnson & Johnson in 2005, which presents risk and benefit information using similar creative executions. The proactive group was not expected nor explicitly coded because the issue developed after this study’s sample was selected and coded.
Rational appeals were used almost 60% of the time versus emotional appeals (40%). While critics have expressed concerns about the overuse of emotional appeals in DTC ads, it should be noted that most DTC-TV ads in the sample used a combination of rational and emotional appeals, rather than just one appeal to the exclusion of the other.
Regarding the presentation of risk information, the average 60-second DTC-TV spot contains less than eight seconds devoted to disclaimers (13% of the total ad time), and 30-second ads had 4.4 seconds of side effects disclaimers (15% of total ad time). Using our classification scheme, there were two lawbreakers (1.9%), 11 bare minimums (10.3%), 93 were in the DTC main pack (87.7%), and no ads in the proactive group.
Is DTC advertising a beneficial source of educational information for consumers or the evil drug-pushing force often portrayed by Congress and the media? As with most questions like this I would say the answer probably lies somewhere in the middle. I personally think that DTC ads could be more responsible and creative.
Pharmaceutical companies and their advertising agencies need to take the time to figure out how to convey information in a way that resonates with the consumer and what is important in his/her life.