Direct-to-Consumer (DTC) Drug Advertisements, Part One

March 11, 2016

FDA is planning to do some major housekeeping when it comes to direct-to-consumer (DTC) drug advertisements. Based on a number of recent announcements, the Agency is planning to study various aspects of television commercials for prescription drugs, including the impact of superimposed text and the inclusion of animated characters.

Additionally, FDA recently announced plans to launch a public survey to ask patients about their experiences with and attitudes toward DTC drug advertisements. Details on the proposed survey are available in our FDA News article entitled “Effectiveness of DTC Drug Advertisements – FDA to Survey Patients About Impact of Ads.”

FDA to Study Effects of Animation in DTC Drug Commercials

From the recent Xifaxan® (rifaximin) commercial featuring an enlarged and personified intestine, to the Zoloft® (sertraline) commercial involving a depressed egg from a few years back, animated advertising has been welcomed by pharmaceutical companies with open arms. Although these ads are becoming increasingly more popular, the effects of animation on consumer comprehension remains unknown; however, this is all about to change.

On March 2nd, the FDA announced plans to conduct a study to find out whether or not animated drug ads are distracting to viewers, taking away from the important safety information being communicated. In a Federal Register notice on the topic, the FDA provided an overview of how it plans to gather the data needed to come to a conclusion. In addition, the notice also stated that, to the Agency’s knowledge, “no studies have comprehensively examined how animation affects consumers’ benefit and risk perceptions in drug ads.”

Use of Animation in Drug Ads

According to the FDA, animation can be used in prescription drug ads in a number of ways. FDA lists rotoscoped animation as the simplest form of animation, which “involves tracing live-action images frame-by-frame to create animated characters.” An example of this is the Abilify® (aripiprazole) television commercial, where the animated character is more of a visual technique used to attract attention, rather than actually relevant to the informational content presented in the ad.

“Animation has also been used 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), or the mechanism of action (e.g., Lunesta).” In these ads, animation personifies a non-human character, providing a memorable illustration of the medical condition or drug attributes. This is the technique used in the controversial Xifaxan commercial that made its debut during Super Bowl 50.

The inclusion of animated characters in advertisements has been studied in the past, but a majority of this research has focused on the outcomes associated with the animated ads, including:

  • Product evaluations
  • Emotional responses
  • Brand attitudes
  • Perceived product value

Furthermore, FDA stated that emotional responses are extremely relevant to their study, as a positive response associated with the animated ads could be transferred to the brand being advertised. “It is also possible that animated characters may lead to lower perceived risk by minimizing or camouflaging side effects.”

Animation’s Effect on Message Communication

The personification of animated characters in TV commercials could interfere with the message being communicated by the sponsoring company. In addition, although personification could increase consumer involvement with the characters in the ad (such as likeability), FDA is afraid that it may not increase consumer involvement with the message itself, such as the risk and benefit information being conveyed.

It is critical for FDA to determine whether or not personified characters reduce the amount of risk and benefit information being comprehended by consumers. Based on the information currently available, there are a number of conflicting opinions, making the answer to that question unclear. Based on a theory called limited capacity model of mediated message processing, some researchers feel that “advertising content that is engaging, relevant, and maximizes audio/visual redundancy should improve learning and memory. However, others argue that the entertainment aspects can distract from learning key information and may lead to message complexity that interferes with message communication.”

FDA’s Two-Part Study

Due to the extraordinary amount of uncertainty regarding the effect of animation in drug ads, FDA is proposing a two-part experimental study, where it will examine how consumer comprehension, processing, and perception of risk and benefit information is influenced by:

  1. Type of animation
  2. Non-human personification

The goal of the proposed study is to determine which of the theories mentioned above is correct as it applies to animated drug ads. In addition, FDA states that “these strategies will be examined across two different medical conditions to see if the findings are consistent across patient populations and medications with different levels of risk.”

The research questions that the Agency will be working to answer are:

  1. “How does consumer process of a DTC prescription drug ad differ depending on whether the ad is live-action, rotoscoped, or animated?”
  2. “Does consumer processing differ depending on whether the sufferer, the disease, or the benefit is the focus of the animation?”

It will be very interesting to watch as the FDA comes to a conclusion and determines the answers to the questions above.

For additional information on FDA’s proposed study, including the design, view the recent Federal Register notice.

Part 2 is now available! Direct-to-Consumer (DTC) Drug Advertisements, Part Two

ProPharma has significant expertise in working through advertising compliance issues. To discuss this or any other FDA-related matter, contact us today.

Agency Alerts

March 11, 2016

Direct-to-Consumer (DTC) Drug Advertisements, Part Two

FDA to Study How Superimposed Text in Direct-to-Consumer Drug Ads Impacts Consumer Comprehension Over the past few weeks, the FDA announced plans to launch public surveys and conduct studies relating...

Read the Full Article
Agency Alerts General Regulatory

March 11, 2016

FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings

On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer.  PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...

Read the Full Article
Agency Alerts General Regulatory

March 11, 2016

FDA Warns Consumers of Numerous Products Containing Hidden Drug Ingredients

On August 9, 2016, the FDA issued five public notifications advising consumers not to purchase or use a number of products, including: Citrus’ Fit Adelgazantes R-II Boss-Rhino Gold X-tra Strength...

Read the Full Article