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

WASHINGTON — Those ever-now TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: recent 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 uncertainty information.

Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a recent pattern emerged: thousands of pharma influencers pushing drugs online with little oversight. A recent invoice 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 history year, led by blockbuster drugs like weight-setback treatment Wegovy, according to ispot.tv, which tracks ads.

The recent rules, which cover both TV and radio, instruct drugmakers to use straightforward, buyer-amiable language when describing their drugs, without medical jargon, distracting visuals or audio effects. A 2007 law directed the FDA to ensure that drug uncertainty information appears “in a obvious, conspicuous and neutral manner.”

FDA has always required that ads provide 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 Night Live.”

But in the early 2000s, researchers began showing how companies could manipulate images and audio to de-highlight 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, unfocused viewers from listening to side result information, making it harder to recall.

Such overt tactics have largely disappeared from drug ads.

“In general, I would declare the ads have gotten more complete and transparent,” says Ruth Day, director of the medical cognition lab at Duke University and author of the Nasonex study.

The recent rules are “significant steps forward,” Day said, but sure requirements could also open the door to recent ways of downplaying risks.

One requirement instructs companies to display 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 packed transcript.

“You often cannot put all that on the screen and expect people to read and comprehend it,” Day said. “If you wanted to hide or reduce the likelihood of people remembering uncertainty information, that could be the way to do it.”

Viewers tend to tune out long lists of warnings and other information. But 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.

“If you’re a corporation and you’re worried about feasible FDA enforcement or product debt and other litigation, all your incentives are to declare more, not less,” said Torrey Cope, a food and drug lawyer who advises companies.

Experts also declare the recent rules will have little result on the overall tone and appearance of ads.

“The most salient element of these ads are the visuals, and they are uniformly positive,” said Cox. “Even if the uncertainty communication is about, for instance, sudden heart setback, they’re still showing someone diving into a swimming pool.”

The recent rules arrive as Donald Trump’s advisers commence 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 U.S. and recent Zealand are the only countries where prescription drugs can be promoted on TV.

Even so, many companies are looking beyond TV and expanding into social media. They often associate with patient influencers who post about managing their conditions, recent treatments or navigating the health structure.

“They’re teaching people to live a excellent life with their disease, but then some of them are also paid to advertise and convince,” said Erin Willis, who studies advertising and media at the University of Colorado Boulder.

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

FDA’s requirement for truthful, balanced uncertainty and advantage information applies to drugmakers, leaving a loophole for both influencers and telehealth companies like Hims, Ro and Teledoc, who may not have a direct financial connection to makers of the drugs they’re promoting.

The issue has attracted attention from members of Congress.

“The power of social media and the deluge of misleading promotions has meant too many youthful people are receiving medical advice from influencers instead of their health worry professional,” Sens. Dick Durbin of Illinois and Mike Braun of Indiana wrote the FDA in a February note.

A recently introduced invoice from the senators would bring influencers and telehealth companies clearly under FDA’s jurisdiction, requiring them to disclose uncertainty and side result information. The invoice also would require drugmakers to publicly disclose payments to influencers.

“It’s asking the FDA to receive a more solemn stance with this benevolent of marketing,” said Willis. “They recognize it’s happening, but they could be doing more.”

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