In 2020, KEI filed a citizens petition with the FDA, asking for a rule banning the use of background music during the presentation of the risks in direct to consumer drug advertising.
The 2020 KEI petition is here:
The docket for the petition is here:
In 2020, Public Citizen made a 10 page submission, telling the FDA it “strongly endorses” the petition. https://www.regulations.gov/docket/FDA-2020-P-1725/comments
Today 3 organizations, U.S. PIRG, the Center for Science in the Public Interest, and Generation Patient, and 7 individuals, wrote to the FDA in support of the petition. Among the 7 individuals are five academic experts and one former pharma CEO.
The letter follows:
Joint Comments in Support of August 3, 2020 Citizen Petition from Knowledge Ecology International requesting the Food and Drug Administration (FDA) to issue a rule banning the use of background music during the presentation of the risks in direct to consumer drug advertising.
Submitted to Regulations.Gov
May 10, 2023
We, the undersigned, ask that the FDA take action on the August 3, 2020 Citizen Petition by Knowledge Ecology International (KEI), requesting the Food and Drug Administration (FDA) to issue a rule banning the use of background music during the presentation of the risks in direct to consumer drug advertising.
While the FDA provided an interim response on January 29, 2021 indicating the petition was under review, the inaction by the FDA on this petition in the two years since is concerning, and we ask that the FDA respond and grant the remedy proposed.
The August 3, 2020 KEI petition addresses a narrow issue. Should drug companies be permitted to use music in audiovisual advertisements during the presentation of the risks of using a product? There is ample evidence that in practice, the music used in such ads is designed to undermine the warnings mandated by the FDA.
As noted in the petition, there is a growing body of scientific literature critical of direct-to-consumer pharmaceutical advertisements, which argue 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.” This means that when drug advertisers use music during an ad’s presentation of a drug’s side effects and risks the companies have the opportunity to lessen the viewers’ comprehension of the product’s risks. This ultimately leads to more consumers believing they should take a drug that their physician might not otherwise prescribe them, which has negative ramifications for patient-physician relationships.
The FDA already regulates the content of DTC advertisements, prohibiting ads from being false or misleading, while also requiring that advertisers give a “fair balance” of information about benefits and risks. The music played during the presentation of risks and side effects can serve as a distraction technique for consumers, tipping the balance away from “fair”.
The petitioner’s charge that profit-driven drug manufacturers and advertisers are deliberately choosing incongruent music to distract from a product’s risks is well documented in the petition and is obvious to anyone who pays attention to the countless audiovisual ads in programming for news, entertainment and sports. As it is beyond the scope and means of the FDA to monitor and screen each advertisement and weigh the level of distraction presented by different types and volumes of music, we therefore ask that the FDA grant the petition and ban the use of music during any audiovisual ads when the risks of the product are discussed.
On behalf of organizations:
Patricia Kelmar, U.S. PIRG
Peter Lurie, MD, MPH, Center for Science in the Public Interest
Sneha Dave, Generation Patient
Signing as individuals:
Ancel·la Santos, Pharmaceutical policy expert
Benjamin N. Rome, MD, MPH, Program On Regulation, Therapeutics, And Law (PORTAL) Brigham and Women’s Hospital, Boston, MA
Hemant Kakkar, Assistant Professor, Duke University, The Fuqua School of Business
Liza Vertinsky, Professor, University of Maryland Francis King Carey School of Law
Melissa Barber, PhD, Harvard University
Michael S. Sinha, MD, JD, MPH, Saint Louis University School of Law