New FDA rules for TV drug ads: Simpler language and no distractions

The ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: new rules require drugmakers to be clearer and more direct when explaining their medications’ risks and side effects. The U.S. Food and Drug Administration (FDA) spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information. Many companies have already adopted the rules, which became binding November 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms. “Some people become very attached to social media influencers and ascribe to them credibility that, in some cases, they don’t deserve,” said Tony Cox, professor emeritus of marketing at Indiana University. The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when describing their drugs, without medical jargon, distracting visuals or audio effects. A 2007 law directed the FDA to ensure that drug risk information appears “in a clear, conspicuous and neutral manner.” The FDA has always required that ads give a balanced picture of both benefits and risks. But in the early 2000s, researchers began showing how companies could manipulate images and audio to de-emphasize safety information. In one example, a Duke University professor found that ads for the allergy drug Nasonex, which featured a buzzing bee voiced by Antonio Banderas, distracted viewers from listening to side effect information, making it harder to remember. The new rules are “significant steps forward,” said Ruth Day, director of the medical cognition lab at Duke University and author of the Nasonex study, but certain requirements could also open the door to new ways of downplaying risks. One requirement instructs companies to show on-screen text about side effects while the audio information plays. A 2011 FDA study found that combining text with audio increased recall and understanding. But the agency leaves it to companies to decide whether to display a few keywords or a full transcript. This article was provided by The Associated Press.