Knowledge Ecology International (KEI), the Center for Digital Democracy (CDD), and three individuals, Manon Ress, Professor Liza Vertinsky, from Emory Law School and Dr. Reshma Ramachandran, a fellow at Yale University School of Medicine, have filed a citizens petition with the U.S. Food and Drug Administration (FDA), asking that music be banned from the sections of direct to consumer advertisements for pharmaceuticals that address side effects and risks.
The petition is 22 pages long, and includes a discussion of existing research on the misleading and distracting nature of information on side effects and risks presented in direct to consumer advertisements for pharmaceuticals, and nine example of television commercials. A copy of the petition is available here in PDF format.
The petition cites studies that demonstrate that the use of music in pharmaceutical ads reduces the ability of consumers to understand and evaluate the portions of the ads which provide what are essentially negative aspects of pharmaceutical products. The following are excerpts from the the text of the petition.
The undersigned submits this Petition pursuant to Section 21 of the Federal Food, Drug, and Cosmetic Act (the “Act”) and 21 C.F.R. § 202.1 to request that the Commissioner of the Food and Drug A dministration (the “Commissioner”) ban the use of music during the presentation of side effects and risks of prescription drugs, in all forms of advertising with sounds (AWS) including but not limited to advertisements on television, radio, social media and Internet web pages.
This petition makes a narrow and important proposal, that the FDA limit the use of music in television, radio and internet streamed advertisements of drugs and vaccines. In particular, we ask the FDA to ban the use of music during the sections of advertisements that discuss the potential side effects and other risks associated with the products.
The FDA already regulates the content of Direct to Consumer (DTC) advertisements, specifying that such ads cannot be false or misleading. It also requires that DTC advertisers give a “fair balance” of information about benefits and risks. These risks may include side effects, allergic reactions, or contraindications.
A growing body of literature is largely critical of DTC advertisements, arguing that DTC ads are designed in ways that use visuals and sound to enhance the impression of health benefits, while using images and sounds to systematically distract attention from the side effects and contraindications of products, which, if following the FDA “fair balance” requirement, should in fact be “comparable in depth and detail with the claims for effectiveness or safety.” (21 C.F.R. § 202.1).
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.
This petition will refer to ads with sounds as AWS, to describe any ads that include sounds, whether the ad is delivered over broadcast television or radio, streamed on social media or Internet web pages, or disseminated through other means of reaching consumers directly.
AWS create special fair balance compliance challenges for marketers of prescription drugs and policymakers because of the interplay of two different sensory modalities (audio and visual) used to present risk and benefit information communicated in a relatively short period of time, and the incongruent nature of the two types of information presented (possible positive and negative outcomes of using the product). These characteristics of DTC AWS create opportunities for distraction of consumers from information in the message. The advertisers’ goal is to sell as much of their product as possible which means that they are incentivised to emphasize the benefits and minimize the risks.
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 the expense and social cost of patients having a reduced comprehension of information on the side effects and risks of products.
Broadcast prescription drug ads and other AWS are required to present major product risks in the audio portion of the ads. In a 2009 Guidance, FDA regulators recommend that risks should be “presented in clear, understandable language without distraction” (FDA, 2009, p.20). The draft guidelines do not offer a definition of distraction per se, but suggest that message elements such as background music, visuals and on-screen text can interfere with consumer comprehension by distracting attention away from the information being presented. This petition will focus on the audio elements alone, specifically background music, and how it works as a distraction to the presentation of risks and therefore is in conflict with the FDA’s fair balance provision and should be banned.
Whether attention-gaining music enhances or distracts from processing may therefore depend on the consistency of meaning conveyed by the music and verbal message. This incongruence between music and message is highly prevalent in television drug commercials. According to the FDA, DTC drug commercials must present a balance of the benefit and risk; however, the background music chosen for most drug commercials often distracts from the risks by being incongruent with its messaging.
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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. Banning music during discussions of side effects has the advantage also of being a clear bright line that is easy to enforce.
VI. Comment on Visual Images in DTC Advertising
There are similar and serious concerns about the distracting and incongruent nature of the use of images in pharmaceutical ad discussions of side effects and risks. Regulating the use of images is important, but beyond the scope of this petition. The elimination of music in the sections of advertisements that present the side effects and risks can and should be implemented now, regardless of the FDA’s future consideration of the problem of inappropriate visual images.
The current state of direct to consumer advertising for prescription drugs is not about patient empowerment. It is not about providing clarity, and it often does not enhance the physician-patient relationship. The FDA should acknowledge that music is used in AWS in order to undermine appreciation and reduce understanding of information regarding side effects and risks of drugs.
Banning music from the risks section of AWS will lead to a more clear and concise presentation of material facts that should be important to the patient. A more informed patient will lead to more accurate diagnosis and better health care for the American people overall.