U.S. regulators want to know how teens perceive direct marketing aimed at them for treatments on conditions as simple as acne and as complex as attention deficit hyperactivity disorder.
The Food and Drug Administration will show adolescents fake websites the agency will create for fictitious prescription drugs that treat acne or ADHD and examine how the teens respond compared with parents and young adults. The study will help determine whether some drugs may require more care when advertising online, the FDA said.
Adolescent development of cognitive, social and emotional skills can influence how they weigh risks and benefits, the FDA said. Research has found the frontal lobe of the brain isn’t fully developed until the mid-20s and affects decision-making, the agency said.
“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 FDA wrote in a document posted online. “Suicide and suicidal ideation has been associated with some of these classes, including a commonly used class of acne medications.”
Isotretinoin, the main ingredient in the once-popular Accutane from Roche Holding AG (ROG) now made in generic versions from Teva Pharmaceutical Industries Ltd. (TEVA) and Mylan Inc. (MYL), among others, has been associated with depression and suicide as well as severe birth defects that require only certain doctors prescribe the drug. Ritalin, Novartis AG’s ADHD medicine, and generic versions, have been linked to hallucinations, delusional thinking and mania as well as aggression in teens.
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