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Regulatory News | 12 September 2014 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product.
FDA announced the proposed study in May 2014, saying that while "previous research has shown that factors such as multiple scene changes and music in advertising can be distracting," that research was limited. "The effects of distraction during the major statement of risks on consumers' perceptions and risk recall have not been tested in the presence of risk-reinforcing superimposed text," FDA said in its Federal Register notice calling for comments on the proposed study.
FDA's proposed study would look at how "potentially distracting images and sounds" might affect risk recall, regulators said.
To assess this, FDA says it plans to conduct an eye-tracking study "to determine how superimposed risk information and the MedWatch statement are perceived in DTC ads and also the impact of distraction," allowing regulators to determine if a participant is actually paying attention to the intended information.
"We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information," FDA explained.
The two-phase study will involve a 30-participant pilot, followed by a 300-participant main study. Participants will be those who self-identify as wanting to lose more than 30 pounds who are at least 18 years of age. The study will focus on a fictitious prescription weight loss drug, and split patients into two groups: one with "low" levels of distractions, and another with "high" levels of distraction. FDA said these advertisements have already been developed and pre-tested.
Now FDA's proposed study has been given the final go-ahead by the Office of Management and Budget (OMB), the federal office in charge of approving all information collections. The approval, announced on 11 September 2014 by FDA in the Federal Register, will allow the agency to proceed with the study as proposed and without change.
The study questionnaires may be found here, while all other information about the study can be found here.
Tags: DTC Advertising, Direct-to-Consumer Drug Advertising, Pharmaceutical Advertising, Distractions in Drug Advertisements