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

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

2024-11-15 04:59 Last Updated At：05:00

WASHINGTON (AP) — 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 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-emphasize 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, distracted viewers from listening to side effect information, making it harder to remember.

Such overt tactics have largely disappeared from drug ads.

“In general, I would say 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 new rules are “significant steps forward,” Day said, but certain requirements could also open the door to new ways of downplaying risks.

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.

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

“You often cannot put all that on the screen and expect people to read and understand it,” Day said. “If you wanted to hide or decrease the likelihood of people remembering risk 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 company and you’re worried about possible FDA enforcement or product liability and other litigation, all your incentives are 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 salient element of these ads are the visuals, and they are uniformly positive,” said Cox. “Even if the risk message is about, for instance, sudden heart failure, they’re still showing someone diving into a swimming pool.”

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. He and other industry critics point out that the U.S. and New 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 partner with patient influencers who post about managing their conditions, new treatments or navigating the health system.

“They’re teaching people to live a good life with their disease, but then 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 consumers generally feel influencers are more trustworthy than companies.

FDA’s requirement for truthful, balanced risk and benefit 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 young people are receiving medical advice from influencers instead of their health care professional,” Sens. Dick Durbin of Illinois and Mike Braun of Indiana wrote the FDA in a February letter.

A recently introduced bill from the senators 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.

“It’s asking the FDA to take a more serious stance with this kind of marketing,” said Willis. “They know it’s happening, but they could be doing more.”

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.

Brief altercation between fans mars France-Israel soccer match

2024-11-15 04:51 Last Updated At：05:00

PARIS (AP) — There was a brief altercation between a small number of fans early into Thursday's Nations League soccer game between France and Israel despite heavy security inside the stadium, a week after violence erupted in Amsterdam in connection with an Israeli club team’s visit.

Around 10 minutes after the game kicked off as scheduled at 8:45 p.m. local time, there was scuffle in the top section of the stand behind one of the goals. It was not clear what caused the altercation and security intervened after around one minute.

French police chief Laurent Nuñez said 4,000 police officers and security staff were deployed in and around the Stade de France, with another 1,500 police on public transport.

Several buses carrying Israel fans arrived under police escort and some were waving flags inside the stadium. Less than 20,000 of 80,000 tickets were sold, with around 150 Israel supporters present.

Paris authorities have been on high alert following the violence in Amsterdam before and after a Europa League match between Ajax and Maccabi Tel Aviv. Dutch authorities said fans from both sides were involved in the unrest. The assaults on Maccabi fans sparked outrage and were widely condemned as antisemitic.

“What we learned from Amsterdam is that we need to be present in the public space including far away from the stadium," and in public transports before and after the match, Nuñez said Thursday on French news broadcaster France Info.

A couple of hours before the game, a pro-Palestinian demonstration attracted several hundred people to a square in Saint-Denis to protest against the match taking place. There were no reported incidents.

Israel's team bus arrived at the stadium shortly after 7 p.m. local time. Around one hour before kickoff, Nuñez visited the stadium’s video surveillance facilities along with French Interior Minister Bruno Retailleau.

Three months after hosting the Olympic closing ceremony, the atmosphere has gone from festive to fearful. French President Emmanuel Macron and Retailleau were present. Former presidents Francois Hollande and Nicolas Sarkozy are also to attend.

“We will not give in to antisemitism, anywhere. And violence, including in the French Republic, will never prevail, nor will intimidation,” Macron told BFM TV channel.

The low number of visiting fans on Thursday comes after Israel’s National Security Council warned citizens abroad to avoid sports and cultural events, specifically the match in Paris.

Retailleau told French news channel TF1 on Tuesday exceptional measures were justified, despite no official threat being received.

The elite tactical unit of the French National Police, known as RAID, was in the stadium and some police in plain clothes mingled with fans. There was also heavy surveillance within Paris, including at Jewish places of worship and schools.

“It is out of the question that we take the risk of seeing a repeat of the dramatic events, of the manhunt, that we saw in Amsterdam,” Retailleau said, adding that postponing or moving the game elsewhere was ruled out.

In Amsterdam, a number of Maccabi fans attacked a cab and chanted anti-Arab slogans while some men carried out “hit and run” attacks on people they thought were Jews, according to city Mayor Femke Halsema.

After the match, parts of a large group of Maccabi supporters armed with sticks ran around “destroying things,” a 12-page report on the violence issued by Amsterdam authorities said.

There were also “rioters, moving in small groups, by foot, scooter or car, quickly attacking Maccabi fans before disappearing,” it said.

Protests erupted in Paris on Wednesday night against a controversial gala organized by far-right figures in support of Israel.

Nine years ago, Stade de France was one of several locations during the Nov. 13 terror attacks in which 130 people died. France was playing Germany that night when two explosions happened outside the stadium.

AP soccer: https://apnews.com/hub/soccer