FDA Study of DTC Ads Reaches Critical Mass

Oct. 20, 2015 – The FDA’s announcement last week that it was accepting comments on two new studies of direct-to-consumer (DTC) television advertising for prescription drugs adds these studies to the growing pile of research the agency is accumulating to better understand consumers’ comprehension of what is being communicated through these ads. To help industry determine where all of these studies stand, the Coalition for Healthcare Communication has outlined their status below.

Descriptions of the most recent studies, which would examine whether consumers comprehend complex risk/benefit information in drug ads and how visual images in those ads interact with quantitative information, were published in the Federal Register Oct. 13 (2015-25958). “The objective of this project is to test consumers’ understanding of quantitative information about prescription drugs in DTC ads,” the notice states.

In study 1, the FDA will “examine experimentally the presence and complexity of quantitative benefit and risk information” in DTC TV ads; study 2 will “examine experimentally the presence of quantitative benefit information and how the ad visually represents efficacy (by having no images, images that accurately reflect the improvement in health that could be expected with treatment, or images that overstate the improvement in health that could be expected with treatment.”

The agency hypothesizes that “overstated images of improvement will lead consumers to overestimate the drug’s efficacy,” but that adding a quantitative claim “may moderate this effect.” These studies would build on a quantitative information study conducted in the past, and would focus on those 60 years of age and older.

As the FDA embarks on another study of the effect of DTC ads on consumers and their understanding of a drug ad’s specifics, the Coalition reached out to the FDA to check in on the status of multiple DTC-related studies the agency has announced during the past several years. The agency’s responses are listed below.

  • Study of viewers’ responses to DTC ad risk information (eye tracking study, proposed May 2014): FDA “is in the process of reviewing the results of this study.
  • Study of adolescents’ perception of DTC ads (proposed July 2014): According to the agency, this study is currently “in the field.”
  • Study of shorter major risk statements in DTC ads (Proposed February 2014 and then response to comments published in January 2015): The agency is “preparing to field the study upon approval.”
  • Study of market claims/efficacy info in DTC ads (proposed July 2015): “The 60-day comment period for this study closed Sept. 18, 2015,” according to the FDA. “We are currently reviewing public comments.”

The FDA is accepting comments on the most recent study until Dec. 14.