FDA is turning its attention to the presentation of disease information in direct-to-consumer prescription drug advertising, with a new online study of more than 4,500 participants.

The forthcoming study will look at how the inclusion of disease information in a branded Rx drug advertisement affects consumer perception of the product. The details of the study are included in a Federal Register notice published June 20. Written comments on the proposed project, “Experimental Study: Disease Information in Branded Promotional Material,” are due by July 20.

“When broad disease information accompanies or is included in an ad for a specific drug, consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement,” the notice states.

For example, the agency says, the mention of diabetic retinopathy in an ad for a drug that lowers blood glucose may lead consumers to infer that the drug will prevent diabetic retinopathy even if the ad does not make a direct claim.

The study will involve a series of prescription drug print ads addressing chronic obstructive pulmonary disease, lymphoma and anemia. A total of 4,650 participants will be recruited from a general population sample and interviewed about their perceptions of the ads. FDA will recruit and conduct the study online.

FDA plans to examine two variables: the type of disease information (possible disease outcomes, versus non-outcome information, versus no information) and the format of the information (integrated with drug information versus separated). Some participants will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address. Others will see disease information that mentions the consequences of the disease that go beyond the advertised product’s indication. And a third group will see the drug product information alone.

Can Consumers Distinguish Disease Information From Product Claims?

The ads will also differ in the way the disease information is presented relative to the product claims. The agency is looking at different options of presenting them, such as alternating paragraphs of product and disease information, putting them on different pages and using different colors and fonts for each.

“If consumers are able to distinguish between the disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad,” the notice states. “If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences.”

FDA issued a notice for public comment on this proposed collection of information in August 2011. It received one public submission. Among other things, the respondent suggested that FDA delete questions related to behavioral intention.

“In an ideal situation, we would be able to measure actual behaviors that may result from exposure to a particular promotional campaign,” the agency says. “Because we cannot do that, we propose to measure participants’ intended behavior; that is, the likelihood that they would engage in specific outcome behaviors that may occur as a result of exposure to the product and disease information.”

The agency notes that its Risk Communication Advisory Committee suggested at its meeting in November that research studies on promotion should measure behavioral intention as an important variable Also see "Lies, Damn Lies, And DTC Ads?" - Pink Sheet, 15 November, 2011..

FDA routinely conducts studies to evaluate the impact of Rx drug advertisements on consumers and health care professionals. Earlier this year the agency announced a study to examine how corrective direct-to-consumer advertising impacts consumer misperceptions about prescription drug product safety and efficacy ([A#14120228008]). And in December it announced plans to conduct a study of comparative DTC advertising to determine how consumers interpret and react to such ads Also see "DTC Comparative Ads Will Likely Bloom; FDA Studies How To Evaluate New Species" - Pink Sheet, 12 December, 2011..

FDA To Study Impact Of Rx Drug Ads That Provide Disease Information

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