Nov. 5, 2013 – The FDA announced last week that it plans to conduct research on how adolescents interpret direct-to-consumer (DTC) advertising that is directed at them, according to a notice published Oct. 31 in the Federal Register (2013-25963). The agency is proposing the study because “the need for understanding how adolescents weigh risks and benefits is particularly critical given the potential adverse events associated with use of the drug classes that are marketed directly to adolescents.”
The agency asserts in the notice that teens are a unique audience for DTC marketing “because their cognitive abilities are different than those of adults and they are usually dependent on adults for health insurance coverage, healthcare provider access and prescription drug payment.”
“This idea is fascinating and the study results promise to be interesting,” said Coalition for Healthcare Communication Executive Director John Kamp. “Good research on how teenagers interpret and process messages and data, and how these perceptions differ from older cohorts, would be very enlightening,” Kamp said. “However, if you think today’s DTC disclaimers are extensive, just wait until you see ads with new FDA disclaimers catering to teens.”
The FDA plans to conduct a randomized, controlled, Internet study of two different medical conditions – attention deficit hyperactivity disorder (ADHD) and acne – that assesses adolescents’ perceptions following exposure to different types of DTC ads for fictitious medicines designed to treat those conditions. The study, which will use three independent variables (timing of risk, severity of risk and timing of benefit), will enroll roughly 6,000 respondents in three specific age groups – 13-15, 16-19 and 25-30 – as well as parents of the two younger age groups.
“Research suggests that the frontal lobe, which controls self-regulatory functions, is not fully developed until the mid-20s … which may lead to difficulty in impulse control and planning,” the notice stated. The study results around the severity of risk variable “will be crucial in determining what types of prescription drugs may require additional care when advertising them to adolescents.”
Other than citing the differences between adolescents and adults and the potential risks presented by medicines that may be marketed to them, the agency does not state in the notice what evidence it may have that DTC advertising to teens needs to be addressed. “The first thing you ask when you see a call for a study like this is whether there is an underlying problem that it will correct, but I don’t see where the agency has made that case,” Jim Davidson, Executive Director, The Advertising Coalition, told CHC. “Is this really among the top issues to be considered right now when we’ve gone years without social media guidance?” he said. “I am at a loss as to why this has been identified as a priority.”Kamp pointed out that it will be important to consider the complete spectrum of information flow surrounding teenage decision making, which likely is skewed heavily by social media interactions, peer-to-peer communication and social context.
The FDA invited comments on the following topics:
(1) Whether the proposed collection of information is necessary for the proper performance of FDA functions, including whether the information will have practical utility;
(2) The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions used;
(3) Ways to enhance the quality, utility and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques, where appropriate, and other forms of information technology.
Although knowing more about how teens perceive DTC advertising is of interest, Kamp noted that “the whole effort raises other important questions, such as (1) Is it really possible to understand the decision-making process of teenagers, who are a heterogeneous group, influenced by so many soft and hard information sources? And (2) Can research on teens really help inform a whole new type of advertising regulation?”
Davidson added that because most adolescents are dependents, their parents play a significant role that must not be overlooked. Further, he noted that there is one additional – and significant – entity that is not mentioned in the notice. “Have we missed the doctor in all of this?” he said.
Comments on the notice are due to the FDA by Dec. 30.