Regulatory Focus™ > News Articles > Drugmakers Criticize FDA’s Plan to Research Animation in DTC Drug Ads

Drugmakers Criticize FDA’s Plan to Research Animation in DTC Drug Ads

Posted 24 October 2016 | By Zachary Brennan 

Drugmakers Criticize FDA’s Plan to Research Animation in DTC Drug Ads

Do the mucous monsters or the little pink, intestine-like cartoon really help consumers learn more about new treatments? Or are these and other animated characters in direct-to-consumer (DTC) pharmaceutical ads just a ploy to grab your attention?

The US Food and Drug Administration (FDA) wants to find out with new research, but drug companies, according to comments unveiled on Monday, are hesitant to see how such limited research could actually lead to new policies or guidance.

The proposal to conduct such research comes as animation has been used in myriad ways in drug ads to symbolize the disease (e.g., Imitrex and Lamisil ads), the sufferer (e.g., Mybetriq and Zoloft), the benefit (e.g., Rozerem), the mode of administration (e.g., Fluzone) and the mechanism of action (e.g., Lunesta).


Back in March, FDA made clear the importance of figuring out whether these cartoons, in whatever form they may be portrayed, inflate consumers’ efficacy perceptions, minimize risk or otherwise hinder the comprehension of drug risks and benefits.

To do so, the agency has proposed a two-part experimental study to examine how: (1) The type of animation and (2) nonhuman personification in drug ads influence consumer comprehension, processing and the perception of risk and benefit information.

In both experiments, participants who have been diagnosed with either chronic dry eye or psoriasis will be recruited via an opt-in Internet panel to watch one ad for a prescription drug that treats their medical condition.

In the first experiment, participants will be randomly assigned to view either a live-action, rotoscoped (tracing live-action images frame-by-frame to create animated characters) or fully animated ad. All themes in this experiment will focus on the main character as the sufferer of the condition.

In the other experiment, participants will be randomly assigned to a personification condition: Sufferer, disease or benefit. All ads will be fully animated and participants will watch the ad once and then answer an online survey with questions addressing their recall of risks and benefits, perceptions of risks and benefits and attitudes and emotional responses to the ad, the brand, the product and the character.

Drugmaker Comments

Despite going to great lengths to try to ensure the research will help to inform FDA in its policies and guidance on DTC ads, a handful of drugmakers are questioning if this research is either a) necessary or b) enough to actually inform changes.

Merck, for instance, offered concerns that the “research may not translate readily into FDA DTC policy/guidance,” and that it “may not have practical utility for the general public and may be unnecessary for the proper performance of FDA’s functions.”

FDA, however, says it believes the study “has the potential to directly influence policy in an area that we have no prior research on… Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. 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.”

GlaxoSmithKline, meanwhile, said the proposed research may “oversimplify animation” by not incorporating multiple types or examining ads that are 100% versus partially animated, and thus be unlikely to yield general conclusions.

FDA, again, while acknowledging this is the first study of its kind, says it feels the animation manipulations proposed will provide information on a reasonable number of variations (i.e., full animation, rotoscoping and three different foci of animated characters).

“We will ensure that our conclusions are reasonable with regard to the issues we studied,” the agency said.

Regeneron Pharmaceuticals took its criticism a step further and encouraged FDA to acknowledge that this study is exploratory and that the results will not be generalizable beyond the two conditions studied. The biotech company also called for more robust and controlled studies to test specific hypotheses generated from the experiment.

FDA said in response to Regeneron: “We are always mindful of how far we can extrapolate our research…We chose to examine two different medical conditions because this will provide some assurance that our findings are not exclusive to one medical condition or execution, if that is what we find. We note that the strength of the study is in its experimental design...However, we agree that other medical situations may cause different reactions and we will acknowledge the limitations of our study, which include not examining all medical conditions and levels of risk, in any write-up we produce.”

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animation in Direct-to-Consumer Advertising

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.