FDA Preparing for DTC Study

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.

“Under many circumstances, people rely much less on facts that they know, such as the number of risks associated with ibuprofen, and much more on general feelings they have, such as strong positivity toward Advil. Compelling visuals in DTC advertising have the potential to lead a consumer to form a positive opinion of a drug for no other reason than that it is presented in the same context as positive images,” the FDA said.

In addition, the use of textual information in TV ads will be evaluated to gauge its effect on processing risk information, the FDA said. The agency expressed concern that textual information can potentially distract viewers away from important auditory messages, the agency said.

The FDA said Synovate, a division of the Aegis Group, will conduct the study, and the Division of Drug Marketing, Advertising and Communications (DDMAC) will oversee the contract.

Ads for high blood pressure medications will be examined, as consumers are less familiar with promotion in that category because of their limited DTC marketing.

According to an annual survey sponsored by DDMAC, Prevention, Men’s Health and Women’s Health, DTC advertising inspires most consumers to seek out additional information for drug products, although few are prompted to request specific medications from their physicians.

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. — Christopher Hollis