For some time now, the FDA’s Office of Prescription Drug Promotion (OPDP) has been engaged in research to assess how risk information comprehension is perceived by audiences in DTC advertisements. Recent efforts have focused on evaluating the use of animation in these ads, but earlier the agency was collecting information on the impact of distractions during the viewing of such ads. The agency has also been looking at the impact of ad exposure frequency in processing risk and benefit information.
The letters this week would appear to be a by-product of that research. While some might think that it would be logical for the agency to issue a written guidance that reflected the results of such studies and thereby better inform industry as to regulatory guardrails. In 2009, a draft guidance did lay out principles for presenting risk information in DTC ads (read “FDA Draft Guidance on Risk Communication: Reading the Tea Leaves”: http://bit.ly/pmn8603p).
According to EyeOnFDA: It would appear that OPDP is using the letters to make a point, perhaps to reflect the study in which the agency has been engaged. Both of the letters involved the same communications vehicle – DTC ads – and both cited a single violation – characterized as false or misleading risk presentation.