WASHINGTON — Drug advertisements on television, frequently depicting individuals enjoying outdoor activities like hiking and biking, may soon adopt a more straightforward and informative approach. New regulations mandate that pharmaceutical companies provide clearer explanations regarding the risks and side effects associated with their medications.
The U.S. Food and Drug Administration (FDA) has spent over 15 years developing these guidelines aimed at eliminating industry tendencies to minimize or obscure crucial risk information. Though several companies have begun following the new rules, which are set to take effect on November 20, 2023, a notable trend has emerged during the regulatory drafting process: Thousands of pharmaceutical influencers are actively promoting drugs online, often with minimal oversight. Consequently, a bill introduced in Congress would require the FDA to monitor these advertisements on social media more closely.
“Many individuals tend to trust social media influencers more than they should,” mentioned Tony Cox, a professor emeritus of marketing at Indiana University. Despite the rise of digital platforms, traditional television advertising remains the leading method for pharmaceutical promotion, with more than $4 billion spent in the last year alone, focusing particularly on successful drugs like the weight-loss medication Wegovy, according to data tracking service ispot.tv.
Under the new regulations, applicable to both television and radio ads, pharmaceutical companies are instructed to use straightforward language accessible to consumers. These guidelines discourage the use of medical jargon, as well as distracting imagery or audio effects.
The FDA has historically mandated that advertisements provide a balanced overview of both the advantages and risks of medications, which often resulted in lengthy and fast-paced lists of side effects that have become something of a cultural punchline on comedic shows like “Saturday Night Live.” However, research from the early 2000s demonstrated how companies could manipulate visual and audio elements to downplay safety information. For instance, a study from Duke University revealed that ads for the allergy medication Nasonex utilized distracting animations, leading audiences to overlook critical side effect details.
While some of these overt strategies have largely vanished from drug ads, improvements in transparency and completeness have been noted. Ruth Day, director of Duke University’s medical cognition lab and author of the aforementioned Nasonex study, emphasized that the new regulations represent meaningful strides forward but could also unintentionally enable fresh methods for underrepresenting risks.
One specific requirement compels companies to display on-screen text regarding side effects while an audio summary plays concurrently. A 2011 study by the FDA indicated that combining visual and audio information enhanced viewer recall and comprehension. However, the FDA permits companies to choose whether to feature just a few keywords or a complete transcript on-screen. “If businesses aim to obscure or lessen the likelihood of viewers remembering risk information, they could manipulate the text accordingly,” Day noted. “Long warnings often lead viewers to mentally disengage.” However, experts familiar with the industry do not anticipate the elimination of these lengthy disclaimers anytime soon. While guidelines delineate presentation methods, the ultimate decision on content rests with the manufacturers.
“If a company is concerned about potential FDA enforcement or legal actions, their best course of action is to include more information rather than less,” stated Torrey Cope, a legal expert specializing in food and drug law. Despite the new regulations, experts argue the overall tone and visual appeal of advertisements are unlikely to change significantly. As Cox pointed out, “The most striking aspects of these ads are the positive visuals. Even when the risk perspective involves severe conditions, like sudden heart failure, advertisements typically depict people engaging in joyful activities.”
The timing of these new rules coincides with discussions about the FDA and the pharmaceutical sector among advisers to former President Donald Trump. Robert F. Kennedy Jr., known for his anti-vaccine stance and serving as an adviser to the president-elect, advocates for the prohibition of televised pharmaceutical advertisements. He, along with other advocates, highlights that the U.S. and New Zealand are the only nations that permit direct-to-consumer advertising of prescription medications.
In light of this, many pharmaceutical businesses are increasingly utilizing platforms beyond traditional television, often collaborating with patient influencers. These influencers share their experiences managing health conditions, exploring new treatments, and navigating the healthcare system. “They offer insights on leading fulfilling lives despite health challenges, yet some also engage in paid promotions,” said Erin Willis, who investigates advertising and media at the University of Colorado Boulder.
Advertising professionals recognize the appeal of social media formats as they usually incur lower costs than television advertising, with consumers tending to view influencers as more credible than corporate entities. Although the FDA mandates that drug companies provide truthful and balanced risk and benefit information in their advertisements, there is a regulatory gap concerning influencers and telehealth companies, which might not always maintain direct financial ties to the drug manufacturers they represent.
This situation has garnered attention from various congressional members. Senators Dick Durbin of Illinois and Mike Braun of Indiana highlighted concerns in a letter to the FDA regarding the prevalence of misleading advertisements targeting young audiences through social media channels. A bill recently introduced by them seeks to establish clear FDA authority over influencers and telehealth companies, ensuring that they also disclose risk and side effect information while requiring drug manufacturers to publicly reveal any payments made to these influencers.
“The legislation calls for the FDA to adopt a more stringent approach toward this form of marketing,” Willis explained. “While they are aware of these trends, more can be done, particularly since their regulations have not been updated in nearly a decade.”
