FDA taking a closer look at DTC animation
- The Food and Drug Administration wants to know how animated characters affect consumers' understanding of drug ads, and has submitted a proposal to study that query to the Office of Management and Budget.
- But big pharma isn't sold on the idea. After the federal agency revealed in early March its plan to develop the proposal, Merck, Eli Lilly, GlaxoSmithKline, Regeneron and AstraZeneca shot back with issues they had concerning the study's design and purpose.
- In its proposal, the FDA cited a wide range of animation types that manufacturers use to market their drugs. They included visualizations of people, illnesses, drug functions and the types of relief a treatment can provide. The agency pointed to Novartis's Lamisil, Pfizer's Zoloft, Takeda's Rozerem, Sanofi's Fluzone and Sunovion's Lunesta as examples of those animations.
As part of the study, the FDA will conduct two studies that test how 1,500 participants retain and perceive information about a drug – particularly its benefits, risks, and brand – as well as animations used in pharmaceutical commercials. While cartoons and other visualizations may offer marketers a better mode to explain a drug, the agency argued that there's not enough available information about their other effects.
"It is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk, or otherwise hinders comprehension of drug risks and benefits," the FDA said in its proposal letter dated October 19 and released October 25.
The FDA will evaluate the results of the study based on participants' answers to questionnaires. A handful of biopharma giants, however, took aim at the structure of the prompts.
Lilly, for example, submitted at least 15 comments during a 60-day window for public feedback that followed the proposal's announcement. The Indianapolis-based company requested the addition of several questions to the surveys, as well as changes to the wording or arrangement of 18 of the existing questions.
Another common theme among pharmaceutical company responses was confusion over the point of the study. Merck suggested that the general public didn't have any practical use for the study, while GlaxoSmithKline and Regeneron wanted the FDA to agree not to generalize the findings.
"We acknowledge that this is the first study to directly examine animation in [direct to consumer] advertising. We are always mindful of how far we can extrapolate our research," the FDA wrote in response to a GlaxoSmithKline comment. "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 writeup we produce."
- Department of Health and Human Services Proposal
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