Drugmakers are required to be clearer about explaining risks and side effects.
WASHINGTON — Those 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 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 become binding Nov. 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.
Still, TV remains the industry's primary advertising format, with over $4 billion spent in the past year, led by blockbuster drugs like weight-loss treatment Wegovy, according to ispot.tv, which tracks ads.
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.”
FDA has always required that ads give a balanced picture of both benefits and risks, a requirement that gave rise to those long, rapid-fire lists of
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