By MATTHEW PERRONE, Associated Press health editor

WASHINGTON (AP) — Those ubiquitous TV commercials showing patients hiking, biking or enjoying a day at the beach may soon look different: New rules require drugmakers to be clearer and more direct when explaining the risks and side effects of their medications. .

The United States Food and Drug Administration spent more than 15 years developing the guidelineswhich aim to eliminate industry practices that downplay or distract viewers from risk information.

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

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

Still, television remains the industry’s leading advertising format, with more than $4 billion spent last year, led by blockbuster drugs like Wegovy weight loss treatmentaccording to ispot.tv, which tracks the ads.

Simpler language and no distractions

The new rules, which cover both television and radio, require drugmakers to use simple, user-friendly language when describing their drugs, without medical jargon or distracting visual 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 advertisements provide balanced image benefits and risks, a requirement that has given rise to those long, quick 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 sound to downplay security information. In one example, a Duke University professor found that commercials for the allergy drug Nasonex, which featured a buzzing bee voiced by Antonio Banderas, distracted viewers from information about side effects, making it more difficult to remember.

Such overt tactics have largely disappeared from drug advertisements.

“In general, I would say ads have become more comprehensive and transparent,” says Ruth Day, director of the Medical Cognition Lab at Duke University and author of the Nasonex study.

The new rules are “significant steps forward,” Day said, but some requirements could also open the door to new ways to minimize risk.

Information overload?

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

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

“A lot of times you can’t put all of this on the screen and expect people to read it and understand it,” Day said. “If you wanted to hide or reduce the likelihood that people would remember risk information, this might be the best way to go.”

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

“If you are a business and you are concerned about possible FDA enforcement or product liability and other litigation, your every incentive is to say more, not less.” , said Torrey Cope, a food and drug lawyer 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 visuals, and they are uniformly positive,” Cox said. “Even if the risk message is about, say, sudden heart failure, they still show someone diving into a swimming pool.”

Patient influencers

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

Even so, many businesses are looking beyond television and turning to social media. They often partner with patient influencers who post about managing their disease, new treatments, or navigating the healthcare system.

“They teach people to live a good life with their illness, but some of them also get paid to advertise and persuade,” said Erin Willis, who studies advertising and media at the University of Colorado in Boulder.

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

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

The issue attracted the attention of members of Congress.

“The power of social media and the deluge of misleading promotions mean that too many young people are receiving medical advice from influencers rather than their healthcare professional,” wrote Senators Dick Durbin of Illinois and Mike Braun of Indiana to the FDA in a February letter. .

A recently introduced senators bill would clearly place influencers and telehealth companies under FDA jurisdiction, requiring them to disclose information about risks and side effects. The bill would also require drugmakers to publicly disclose payments made to influencers.

“This calls for the FDA to take a more serious stance with this type of marketing,” Willis said. “They know it’s happening, but they could do more and their regulations haven’t been updated since 2014.”

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

Originally published: November 14, 2024 at 9:07 a.m. CST