On October 30, 2013, the U.S. Food and Drug Administration (FDA) announced that it is seeking public comments on research titled: “Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.” The pre-publication notice is available here, and final publication is expected in the October 31, 2013 Federal Register. According to the FDA, this study is “designed to examine how adolescents interpret DTC advertising directed at them”.
The notice describes a proposed randomized, controlled study intended to assess adolescents’ perceptions following exposure to different types of web-based DTC prescription drug advertising (promoting fictitious medications indicated for Attention Deficit Hyperactivity Disorder (ADHD) and acne). The FDA proposes to explore the role of three different factors that may influence adolescent understanding and perceptions of DTC: (1) the timing of the onset of benefits; (2) the timing of the onset of risks; and (3) whether the severity of the risk within each condition influences adolescent decision-making in relation to DTC advertising. Among other things, specific comments are sought regarding: “whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility”, “the validity of the methodology and assumptions used” and “ways to enhance the quality, utility, and clarity of the information to be collected.”
The notice does not further clarify how the FDA intends to use the information proposed to be collected. Over the past few years, the agency has shown significant interest in studying the marketing of prescription drug products. The FDA’s Office of Prescription Drug Promotion (OPDP) Research website describes the following ongoing research projects: “Communication of Effectiveness Information in DTC Print Ads”; “Communicating Composite Scores in DTC Advertising”; “Disease Information in Branded Promotional Material”; “Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits”; “Examination of Comparative Claims”; “Examination of Corrective DTC Television Advertising”; “Examination of Online DTC Drug Promotion”; “Experimental Study of Format Variations in the Brief Summary of DTC Print Advertisements”; “Healthcare Professional Survey of Prescription Drug Promotion”; “Patient Medication Information”; “Risk and Benefit Perception Scale Development.” According to the OPDP, such studies “will inform our understanding of important issues such as the impact of corrective advertising, promotional offers, disease awareness information, and more.” Accordingly prescription drug manufacturers (particularly those with products that may be indicated for use by adolescents) may wish to review and comment on the proposed research. Comments will be accepted until 60 days after the publication of the notice in the Federal Register – likely December 30, 2013.