DTC Advertising

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Aug. 3, 2020 – The background music in direct-to-consumer (DTC) ads “is a distraction from the presentation of risks … and bombards the viewer with excess stimuli making it difficult for them to retain the information,” according to an Aug. 3 Citizen Petition sent to the Food and Drug Administration (FDA) by Knowledge Ecology International (KEI), the Center for Digital Democracy (CDD) and three individuals.

The KEI/CDD petition covers ads delivered over broadcast television or radio, streamed on social media or Internet web pages, or disseminated through other means of reaching consumers directly; it argues that research on the presentation of risks and side effects demonstrates that music can be a distraction and asks the FDA to ban music from the sections of pharmaceutical DTC ads that address side effects and risks.

“Banning background music from DTC drug advertisements when side effects are discussed is the logical step for the FDA to take in order to achieve the goals that they have already presented and are currently attempting to enforce,” the petitioners state. “Banning music during discussions of side effects has the advantage also of being a clear bright line that is easy to enforce.”

The petition explains that the FDA already regulates the content of DTC ads, specifying that such ads cannot be false or misleading, and also requires that DTC advertisers give a “fair balance” of information about benefits and risks. The petition also asserts that “a significant and avoidable problem is the widespread employment of distraction techniques, such as the use of background music during the presentation of the risks in television and other broadcast or streamed advertisements that include multimedia content.”

Further “advertisers use background music in order to achieve an outcome that is more favorable to expanding sales than would be the case if the company honored the intent of the FDA’s current provisions, however, it comes at the expense and social cost of patients having a reduced comprehension of information on the side effects and risks of products,” according to the petitioners.

The FDA’s Office of Prescription Drug Promotion (OPDP) has cited companies in the past for using music in ways that it deems an impediment to consumer understanding of risk information.

In a 2016 Untitled Letter to Celgene Corp., OPDP stated that throughout a TV ad for OTEZLA®, including the major statement, an instrumental version of the song, “Walking on Sunshine” is played in the background. “However, during the major statement, a loud brass interjection is played over several audio risk disclosures. The presentation of these compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message, in addition to the frequent scene changes and the other competing modalities such as the musical interjections, compete for the consumers’ attention,” OPDP asserts.

“As a result, it is difficult for consumers to adequately process and comprehend the risk information. The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Otezla,” the OPDP enforcement letter states.

In a 2016 Untitled Letter to Sanofi-aventis US, OPDP cited the company’s ad for TOUJEO®, stating that “frequent scene changes and the other competing modalities such as the background music, compete for the consumers’ attention. As a result, it is difficult for consumers to adequately process and comprehend the risk information. The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo.”

“OPDP has in the past taken action against specific situations where it believed the tone or timing of music obscured important information, yet it has not proposed an outright ban on music during the risk statement,” noted Jon Bigelow, executive director of the Coalition for Healthcare Communication. “It is unlikely it would do so without conducting careful research on this issue.”

Although OPDP has conducted numerous research studies on various aspects of DTC ads and how they impact consumers, it has not yet studied the specific impact the music in a DTC ad may have on consumer understanding of risk information.