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New FDA Rules for TV Drug Ads: Simpler Language and No Distractions

WASHINGTON (AP) — The ever-present TV ads for drugs showing patients walking, biking or enjoying a day at the beach may soon look different: New rules require drugmakers to be clearer and more direct in explaining the risks and side effects of their medications.

The U.S. Food and Drug Administration spent more than 15 years developing the guidelinesdesigned to end industry practices that downplay or distract viewers from risk information.

Many companies have already adopted the rules, which will become binding from November 20. But as regulators were drafting them, a new trend emerged: thousands of pharmaceutical influencers pushing drugs online with little oversight. A new bill in Congress would force the FDA to more aggressively police such promotions on social media platforms.

“Some people become very attached to social media influencers and attribute credibility to them that, in some cases, they don’t deserve,” says Tony Cox, professor emeritus of marketing at Indiana University.

Yet television remains the industry’s leading advertising format, spending more than $4 billion last year, led by blockbusters like weight loss treatment Wegovyaccording to ispot.tv, which tracks advertisements.

Simpler language and no distractions

The new rules, which apply to both television and radio, instruct drug makers to use simple, consumer-friendly language when describing their drugs, without medical jargon, distracting images or audio effects. A 2007 law directed the FDA to ensure that information about drug risks appears “in a clear, conspicuous and neutral manner.”

The FDA has always required that advertising be a balanced picture of both benefits and risks, a requirement that gave rise to those long, rapid-fire lists of side effects parodied on shows like ” Saturday evening live.”

But in the early 2000s, researchers began showing how companies could manipulate images and audio to emphasize safety information. In one example, a professor at Duke University found that ads for the allergy drug Nasonex, featuring a buzzing bee narrated by Antonio Banderas, distracted viewers from listening to information about side effects, making it harder to remember.

Such overt tactics have largely disappeared from drug advertisements.

“Overall, I would say the ads have become more complete and transparent,” said Ruth Day, director of the medical cognition laboratory at Duke University and author of the Nasonex study.

The new rules are “important steps forward,” Day said, but certain requirements could also open the door to new ways to downplay risk.

Information overload?

One requirement instructs companies to display text about side effects on the screen while the audio information is playing. A 2011 FDA study found that combining text with audio increases recall and comprehension.

But the agency leaves it up to companies to decide whether to display a few keywords or a full transcript.

“You often can’t put all that on the screen and expect people to read it and understand it,” Day said. “If you want to hide the chance or reduce the chance of people remembering risk information, that could be the way to do it.”

Viewers tend to ignore long lists of warnings and other information. But experts who work with pharmaceutical companies don’t expect those lists to disappear. Although the guidelines describe how the information should be presented, companies still determine the content.

“If you’re a company and you’re concerned about potential FDA enforcement, product liability and other lawsuits, all your incentives are to say more, not less,” says Torrey Cope, a food and drug attorney who advises companies.

Experts also say the new rules will have little effect on the overall tone and appearance of ads.

“The most striking element of these ads are the images, and they are without exception positive,” says Cox. “Even if the risk message is about sudden heart failure, for example, they still show someone diving into a pool.”

Patient influencers

The new rules come as Donald Trump’s advisers begin making 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. He and other industry critics point out that the US and New Zealand are the only countries where prescription drugs can be promoted on television.

Yet many companies are looking beyond TV and expanding into social media. They often work with patient influencers who post about managing their conditions, new treatments, or navigating the healthcare system.

“They teach people how to live well with their disease, but some of them are also paid to advertise and persuade,” said Erin Willis, who studies advertising and media at the University of Colorado Boulder.

Advertising executives say companies like the format because it’s cheaper than TV and because consumers generally feel influencers are more trustworthy than companies.

The FDA’s requirement for truthful, balanced information about risks and benefits applies to drug makers, leaving a loophole for both influencers and telehealth companies such as Hims, Ro and Teledoc, who may not have direct financial ties to the makers of the drugs they promote.

The issue has caught the attention of members of Congress.

“The power of social media and the deluge of misleading promotions have led to too many young people getting medical advice from influencers instead of their healthcare provider,” Senators Dick Durbin of Illinois and Mike Braun of Indiana wrote in a February letter to the FDA. .

A recently introduced one bill from the senators would clearly bring influencers and telehealth companies under the jurisdiction of the FDA, requiring them to disclose information about risks and side effects. The bill also requires drugmakers to disclose payments to influencers.

“It calls for the FDA to take a more serious stance regarding this type of marketing,” Willis said. “They know it’s happening, but they could do more.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.