Direct-to-Consumer (DTC) Drug Advertisements, Part Two

FDA to Study How Superimposed Text in Direct-to-Consumer Drug Ads Impacts Consumer Comprehension

Over the past few weeks, the FDA announced plans to launch public surveys and conduct studies relating to the promotion of direct-to-consumer (DTC) advertisements for prescription drugs. As part of this “spring cleaning,” on March 9, 2016 the Agency proposed an additional study, which will examine how the size and presentation of superimposed text (supers) impacts consumer comprehension of DTC television ads for prescription drugs.

FDA would like to conduct this study in order “to extend previous research on the effects of supers in general print and television advertising to today’s modern DTC pharmaceutical promotion.” The Agency states that, although previous research suggests that altering text size can impact consumer comprehension, it is necessary to determine if these findings, which are more than 20 years old, are still applicable when viewing DTC ads for prescription drugs using today’s modern technologies. In addition, FDA also wants to look into whether or not text/background contrast may “influence both the understanding of the superimposed information and the effects of text size.”

This study is being proposed as a part of FDA’s public health mission, which seeks to ensure the safe use of prescription drugs. In doing so, FDA states that it is important that the information being presented in DTC advertisements is:

• Clear and understandable for consumer audiences.
• Avoids use of deceptive or misleading claims.
• Achieves ‘‘fair balance’’ in presentation of benefits and risks.

FDA’s study will address a number of unanswered questions regarding the use of superimposed text in the promotion of prescription drugs. The specific research questions that the Agency will be working to answer are:

1. Does the size of the superimposed text, the contrast behind the superimposed text, and/or the device type influence the noticeability, recall, and perceived importance of the super information?
2. Does the size of the superimposed text, the contrast behind the superimposed text, and/or the device type influence the recall of and attitudes toward the promoted drug?
3. Are there any interaction effects among any combination of independent variables?

To test these questions, FDA will conduct one randomized controlled study. In this study, FDA has stated that it “will examine reactions to supers in a fictitious DTC prescription drug promotional video on two types of viewing devices with a general population sample. The study design will be a 3 × 2 × 2 factorial design, where participants are randomly assigned to one of twelve experimental study arms differentiated by:

• Super text size (small, medium, large);
• Device type (television, tablet); and
• Super text contrast (high, low).”

FDA is seeking feedback and is asking interested parties to submit comments by Monday, May 9th.

For more details on FDA’s proposed study, view the recent Federal Register notice.

For additional information on FDA’s recent activity related to DTC advertisements for prescription drugs, view our FDA News articles entitled:

• Direct-to-Consumer (DTC) Drug Advertisements, Part 1

• Effectiveness of DTC Drug Advertisements – FDA to Survey Patients About Impact of Ads

The Weinberg Group has significant expertise in working through advertising compliance issues. To discuss this or any other FDA-related matter, contact us today.