How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising.
The study was first announced in October 2013. At the time, FDA noted that adolescents may understand drug advertisements differently than their adult counterparts, and postulated that they are likely less averse to risk, less able to process information presented to them and less able to understand the limits of a drug's efficacy.
"Different cognitive, social and emotional, and developmental processes in the adolescent brain mature simultaneously and at different rates, affecting decision-making by age," FDA wrote in a synopsis of the proposed study. "All of these factors can influence how adolescents perceive and process information as well as weigh risks and benefits."
Of particular concern to FDA are drugs aimed at teenagers, such as acne medications, which are associated with some serious risks like suicidal ideation. Regulators said they want to know if there are ways of presenting drug information to adolescents that might further mitigate risks, such as by presenting risk information "in ways [they] can understand."
The study proposed by FDA will look at two separate, fictional promotional campaigns: One for an attention deficit hyperactivity disorder (ADHD) medication, and another for an acne medication.
Three factors will be targeted by regulators. The first two will assess whether adolescents are more likely to discount long-term risks in favor of benefits that occur immediately. "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, and thus decisionmaking," FDA wrote.
FDA also wants to assess whether teenagers are less influenced by severe warnings relative to their adult counterparts.
Information obtained from the study "will be crucial in determining what types of prescription drugs may require additional care when advertising them to adolescents," FDA wrote.
The study—to be conducted over the Internet—is set to divide participants into four groups: Those aged 13-15, 16-19, 25-30, and a fourth group of "parents of the two younger age groups," meant to help FDA determine differences between the reactions of teenagers and their parents.
The proposed study has been submitted to the Office of Management and Budget (OMB) and is now awaiting government approval, FDA said.
Federal Register Notice