Drugmakers spar with FDA over proposed DTC animation study

The FDA is planning to conduct a pair or studies evaluating the use of animation and superimposed text used in DTC ads. Photo credit: King-of-Herrings/Creative Commons

Drugmakers took issue with the design of two planned FDA studies examining the use of animation in direct-to-consumer advertising, according to comment letters released this week.

The FDA had announced plans to study the use of superimposed text and animation in DTC advertising. The agency said it hopes the studies will answer two questions: Do consumers process ads with animation differently? And is consumer understanding affected when animation is used to personify a disease, a drug's benefit, or the patient? The FDA first posted a notice in March asking for public comment on how it will conduct this research. That comment period ended in May. The notice published earlier this week is to allow for comment on that proposed collection, which includes both industry comments and the agency's responses to their input. 

The FDA, in the proposed guidance, said it would look at how rotoscoping or live action animation is used in DTC ads, with plans to ask participants about the uncanny valley hypothesis or whether they felt that live action animation elicits a feeling of eeriness in viewers.

See also: The FDA wants to study DTC tactics

One recent example of this is Allergan and Ironwood Pharmaceuticals' ad for IBS-C treatment Linzess, which used live action animation to show the different ways the disease affects a patient's daily life.

Eli Lilly criticized that question in a comment letter, calling it “leading” and saying “it directs participants to respond only negatively about their perceptions of the character.” Citing the uncanny valley hypothesis, the FDA responded that it felt it was crucial to keep the question.

Merck also weighed, saying that results from this research “may not translate readily into FDA DTC policy/guidance” because the research largely addresses how the execution of certain kinds of animation affects perception. The FDA responded by saying that it needs to build a foundation of research on this subject “because there is no previous research of this kind. This will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to.”

See also: Industry criticizes FDA's proposed DTC studies

Another drugmaker, GlaxoSmithKline, said the research may be reductive because it “oversimplifies animation by not incorporating multiple types of animation or examining ads that are 100% versus partially animated” and because of that “is unlikely to yield any general conclusions about the use of animation.” The FDA said that it is using a “reasonable” number of variations including full animation and rotoscoping, saying it will “ensure that our conclusions are reasonable.”

The comment period highlights tension between the FDA and the pharma industry over the extent to which regulatory research should inform new policy and to what degree animation affects consumer perception. The industry levied criticism at the agency over its word choice for some survey questions, the extrapolation of this study's results into policy, and oversimplifying animation by not incorporating multiple types of the tactic.

The full comments from the industry and responses by the FDA can be read here.

Correction: An earlier version of this article misstated the drug advertised by Allergan and Ironwood Pharmaceuticals using live-action animation. It is Linzess, not Viberzi.