New FDA Rules Require Simpler Language for TV Drug Ads
Simpler Language and No Distractions
The U.S. Food and Drug Administration spent more than 15 years crafting new guidelines that require drugmakers to be clearer and more direct when explaining their medications’ risks and side effects. The rules, which become binding on November 20, aim to do away with industry practices that downplay or distract viewers from risk information.
The new rules 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.”
Information Overload?
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. However, the agency leaves it to companies to decide whether to display a few keywords or a full transcript.
Viewers tend to tune out long lists of warnings and other information. Experts who work with drug companies don’t expect those lists to disappear. While the guidelines describe how the information should be presented, companies still decide the content.
Patient Influencers
The new rules come as Donald Trump’s advisers begin floating plans for the FDA and the pharmaceutical industry. Robert F. Kennedy Jr., an anti-vaccine activist who has advised the president-elect, wants to eliminate TV drug ads.
Many companies are looking beyond TV and expanding into social media. They often partner with patient influencers who post about managing their conditions, new treatments, or navigating the health system. Advertising executives say companies like the format because it’s cheaper than TV and consumers generally feel influencers are more trustworthy than companies.
What’s Changing?
* Drugmakers must use simple, consumer-friendly language when describing their drugs
* No medical jargon, distracting visuals, or audio effects
* On-screen text about side effects while audio information plays
* Companies decide whether to display a few keywords or a full transcript
What’s Not Changing?
* The overall tone and appearance of ads
* The requirement for truthful, balanced risk and benefit information applies to drugmakers, leaving a loophole for influencers and telehealth companies
What’s Next?
* A recently introduced bill from Senators Dick Durbin and Mike Braun would bring influencers and telehealth companies clearly under FDA’s jurisdiction, requiring them to disclose risk and side effect information
* The bill also would require drugmakers to publicly disclose payments to influencers
Conclusion
The new FDA rules aim to improve transparency and clarity in TV drug ads. While some experts are concerned about the potential for companies to downplay risks, the rules are a significant step forward in ensuring that consumers have access to accurate and balanced information about prescription medications.
FAQs
Q: What are the new FDA rules for TV drug ads?
A: The rules require drugmakers to use simple, consumer-friendly language when describing their drugs, without medical jargon, distracting visuals, or audio effects.
Q: What is the goal of the new rules?
A: The goal is to improve transparency and clarity in TV drug ads, ensuring that consumers have access to accurate and balanced information about prescription medications.
Q: What is the concern about patient influencers?
A: The concern is that patient influencers may be promoting drugs without disclosing risk and side effect information, and that they may be more trustworthy than companies.
Q: What is the proposed bill from Senators Durbin and Braun?
A: The bill would bring influencers and telehealth companies clearly under FDA’s jurisdiction, requiring them to disclose risk and side effect information, and would require drugmakers to publicly disclose payments to influencers.
