The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.
In a notice
posted to today's Federal Register, the agency cited ads run by Bayer
in 2009 at FDA's behest to remedy false or misleading claims and omissions it had made in prior ads for its Yaz contraceptive. However, the agency said, “researchers and policymakers currently lack exhaustive empirical literature regarding the various impacts of corrective DTC advertisements on prescription drug consumers. The current project will examine how variations in corrective advertising may impact consumers' misleading product beliefs.”
Researchers will manipulate three independent variables: message exposure, similarity of original and corrective ands, and length of time between exposure to original and corrective ad in a “medium-prevalence” medical condition, or one affecting 5%-10% of the US adult population. The study will be conducted online and will have two phases, with Phase 1 varying exposure to messages in order to determine how exposure to a combination of original and corrective ads affects recall, comprehension, perceptions of risk and efficacy and intent to ask about the drug featured. Phase 2 will examine whether an ad's corrective ability relates to similarity to the original ad or time between seeing the original and corrective spots.
The agency will have to wait for a 60-day public comment period, which ends April 30, to close before getting started. Comments can be submitted electronically here