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FDA Preparing for DTC Study

August 22, 2007

The FDA is planning to examine whether visual images in direct-to-consumer (DTC) television advertisements alter viewers’ perceptions of risk information, according to an Aug. 22 Federal Register notice.

Positive and compelling visual images can influence the process of considering risk information by distracting consumers, the FDA said. “A consistently raised question is whether advertising visuals of benefits interfere with consumers’ understanding and processing of the risk information in the ad’s audio or text,” the FDA said.

The effort to study DTC broadcast advertising is an apparent response to critics of the practice. The agency stated in the notice that both healthcare providers and consumers have expressed concerns that the FDA cannot adequately regulate prescription drug advertising, especially as it relates to balancing the communication of risks and benefits.

The study, which will screen approximately 2,000 individuals to obtain a respondent sample of 1,020 viewers, will also assess how visual images affect perceptions of advertised brand drugs in relation to generic alternatives.

However, the study is not expected to commence for at least several months, as the FDA must process comments and obtain Office of Management and Budget approval. More information can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/07n-0321-n000001.pdf. Comments are due Oct. 21.