The FDA has submitted a request to the Office of Management and Budget to use the internet to survey 2,400 consumers on responses to fake pharmaceutical ads for fictional blood pressure pills, according to a notice posted Tuesday on the agency's website.
The agency said that they are undertaking the “experiment” because “both healthcare providers and consumers have expressed concerns to [the] FDA about the effectiveness of its regulation of manufacturers' direct-to-consumer (DTC) prescription drug advertising, especially as it relates to assuring balanced communication of risks compared with benefits.”
Those who oppose DTC advertisements have criticized the use of compelling visuals in television broadcast ads. “Many assert that the visuals present during the product risk presentation are virtually always positive in tone and often depict product benefits. A consistently raised question is if advertising visuals of benefits interferes with consumers' understanding and processing of the risk information in the ad's audio or text,” according to the FDA.
Drugmakers spend $30 billion a year marketing products in the U.S., triple what they did a decade ago, according to a 2007 study in the New England Journal of Medicine.
The FDA is "responding to criticism of many of us that the risk information is underplayed" in ads, Steve Findlay, a healthcare analyst for Consumers Union, the publisher of Consumer Reports, told Bloomberg News. "It's unfortunate that this has taken so long, but I think we'll probably learn some valuable things from this."
The agency said that the purpose of the proposed study is, in part, to determine whether the use of competing, compelling visual information about potential drug benefits interferes with viewers' comprehension of risk information about drugs in DTC advertising or with their cognitive representations of the drugs.
According to the FDA, a second purpose of the study is to examine the role of textual elements in the processing of risk information.
The final purpose of this study is to provide the FDA with information on defining the presentation of the major statement as ‘clear, conspicuous, and neutral,’ as required by Food and Drug Administration Amendments Act of 2007 (FDAAA).
The agency acknowledged that it has limited data about how consumers perceive risk and benefit from information in DTC broadcast ads, as a function of exposure to different content and presentations.
According to the FDA, eligible participants for the study (2,400, following pretesting) will be recruited from Synovate’s online internet panel. The participants will be 40 years of age or older to increase the likelihood of including members of the population most likely to have high blood pressure.