FDA Policy/General

Issues Found in TV Ad ‘Major Statements’: Study

FDA direct-to-consumer ad researchers say their content analysis of 50 television direct-to-consumer (DTC) prescription drug ads airing between 7/2012 and 8/2014 suggests an unintended consequence of a focus on risk completeness without an accompanying focus on understandability. The study analysis is reported in the journal Health Communication (subscription or purchase required).

FDA regulations require drug manufacturers to disclose the major risks in their prescription drugs through what is known as a “major statement” in DTC television ads. “For the major statement to be useful to consumers,” the report says, “it should be presented in ways that make it easy for consumers to understand. This includes the language used to describe the risks, the visuals on the screen during the major statement, and the audio.”

The researchers say they used subjective and objective measures to code the major statements in the ads. They found that the major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks’ severity or prevalence. Major statements required a high school reading level, and many included long and complex sentences. The researchers found that the major statements were often accompanied by competing non-risk information images, presented with moderately fast-paced music, and read at a faster pace than benefit information.

The study found that more risks are being listed in ads than were given in ads from earlier years. “The increased regulatory and industry focus on the communication of risk information since 2007 might have led to an increase in the number of risks presented in DTC television ads, without a corresponding increase in the accessibility of this information,” the authors conclude. “Thus, our results suggest an unintended consequence of a focus on risk completeness without an accompanying focus on understandability. [Previous] recommendations for improving the communication of risk information have yet to be heeded. In particular, our research suggests a need to consider further the ordering of risks within the major statement (prevalence vs. severity), the health literacy levels of ads, lack of quantitative information in presenting risks, and the competing effects of multiple visuals when conveying critical information.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome