FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, the agency announced that it is seeking additional comments on its experimental study of risk information in DTC print ads until Sept. 13.

Overwarning, the agency explains in the Aug. 14 notice, is the concept that multiple warnings may cause consumers to pay less attention to any particular warning. “In terms of presenting risk information, detailing too many risks may lead consumers to discount all risks, or miss the most important risk information,” the notice states. The agency also will collect data on whether “habituation” – when readers see the same warning repeatedly and cease to pay attention – occurs with warnings in two places in drug ads.

Accordingly, FDA’s Office of Prescription Drug Promotion (OPDP) “plans to investigate, through empirical research, various combinations of the ISI and brief summary. We propose to test two levels of the ISI (short versus long) and the presence of a consumer brief summary (absent versus present) in two different medical conditions (overactive bladder and rheumatoid arthritis).”

The study will employ eye-tracking technology to measure “the extent to which consumers attend to risk information presented in DTC print ads” in (1) the ISI; (2) the brief summary; and (3) the indication and benefit claims.

“To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance,” according to the agency. The full study will include a total of 400 main study voluntary participants and will exclude healthcare professionals and those who work for the Department of Health & Human Services or in pharmaceutical, advertising or marketing settings.

A comment submitted about the study when the agency first called for comments on it in June 2017 asked whether or not a consumer should be expected to make a risk/benefit assessment of a drug simply by reading an ad. “Such an assessment can occur only after a patient has had a discussion with his/her healthcare provider,” the comment states.

The FDA responds in the Aug. 14 notice that it “seeks to improve our understanding of what baseline judgements about product risks and benefits individuals make on the basis of advertising.” The FDA added that the FDA does not expect that “the advertisement will be the sole basis for individuals to assess benefit and risk or make ultimate healthcare decisions.”

The agency announced final details on a study of disclosure placement in drug ads on Aug. 13 (