Over the past few years, more drug makers have run TV ads featuring cartoon characters or other animation techniques to promote their medicines. But while some may be cute or visually striking, regulators wonder whether these ads interfere with consumer comprehension.

So the Food and Drug Administration plans to run a study to determine whether these visual tools may distort how consumers perceive the risks and benefits of a medicine, according to a notice posted this week in the Federal Register.

It is “possible that animated characters may lead to lower perceived risk by minimizing or camouflaging side effects,” the agency wrote, adding there is concern that “entertainment aspects can distract from learning key information.”

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The agency acknowledged that some may argue animated ads that are humorous and engaging can improve learning and memory. A 2009 study, for instance, found that drug ads featuring animated characters increased consumer recall of brand-name medicines. But the FDA also believes the study left some questions unanswered.

“I think we are seeing more of these animated ads,” said John Mack, who publishes Pharma Marketing News. “The companies believe the ads can make the products or message friendlier or more appealing. And animation can be used to counteract the unappealing nature of the medication or the side effects that are listed.”

A notable example is Jublia, a toenail fungus treatment sold by Valeant Pharmaceuticals, which promoted the medicine during the recent Super Bowl.

Overall, the pharmaceutical industry spent about $3.6 billion on direct-to-consumer advertising during the first half of last year, up from $3.2 billion during the comparable period in 2014, according to Kantar Media. However, spending figures on animated ads were not available.

In explaining its concerns, the agency pointed to the different ways that drug makers have used animation. Some ads, for instance, used animation to symbolize disease, such as the Lamisil ads from Novartis (NVS) that used “Digger the Dermatophyte” to explain toenail fungus.

Other uses included the mechanism of action seen in Lunesta sleeping pill ads that featured a butterfly.

The agency also pointed to rotoscoping, a technique in which animators trace over footage for use in live action and animated films. As an example, the FDA pointed to an ad for the Abilify antipsychotic in which this technique appeared to be used to attract attention.

But the agency believes that it is unclear whether an ad with a rotoscoped human results in greater comprehension of benefits and risks than an ad with a human actor. “The few studies that have examined this technique in drug ads have found that animated human characters either had no effect on perceived product risk or led to poorer recognition of drug side effects,” the FDA wrote in the notice.

The agency study, which plans to enroll 1,500 people, will involve creating two make-believe drugs — one for chronic dry eye and the other for psoriasis.

Why these illnesses? The FDA notes that, unlike medications for psoriasis, which have long and serious risks and side effects, chronic dry-eye medications have relatively few. The idea, of course, is to provide a strong contrast for consumers to consider as they watch the animated ads.

The FDA hopes the studies will answer two key questions: To what extent do consumers process ads that use animation differently than other ads, and does consumer comprehension differ depending on whether the animation depicts the disease, the benefit of the drug, or the patient.

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