FDA regulations for direct to consumer pharmaceutical advertising require fair balance. An advertisement is considered to provide fair balance when its presentation of drug risks and benefits is reasonably comparable. Given the regulation's explicit comparison of benefit and risk information presentation, content analysis is the most common means of determining whether this requirement has been met. Research was conducted to determine if content analysis is, in fact, sufficient for determining if fair balance exists. The research, keeping benefit information consistent, measured how the number of side effects associated with a particular drug, the perceived severity of side effects, and the order and mode in which side effects are presented impact consumer attitudes and subsequent evaluations of fair balance. Findings indicate that content analysis alone may be insufficient, and that content analysis combined with an assessment of consumer reactions and attitudes after viewing a DTC advertisement may be a better means for determining fair balance. Implications for DTC regulation and DTC advertisers are presented and discussed.
