WASHINGTON (AP) – Traditionally televised drug ads showing patients hiking, biking or enjoying a day at the beach could soon look different. The new rules will require drug companies to be more clear and direct when explaining the risks and side effects of their medicines.
The U.S. Food and Drug Administration has spent more than 15 years guidelinesdesigned to eliminate industry practices that downplay risk information or distract viewers.
Many companies have already adopted the rules, which will become binding on November 20th. But while regulators were drafting the rules, a new trend emerged. It says thousands of pharmaceutical industry influencers are promoting 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 so attached to social media influencers that they sometimes give them credibility that they don’t deserve,” said Tony Cox, professor emeritus of marketing at Indiana University.
Still, television remains the industry’s primary advertising format, with more than $4 billion spent in the past year, driven by blockbuster drugs such as: Weight Loss Treatment WegovyAccording to ispot.tv, which tracks ads.
Simple language and no distractions
The new rules, which cover both television and radio, require pharmaceutical companies to explain their medicines in a simple, consumable format, without medical jargon or distracting visual and sound effects. It instructs people to use kind words. The 2007 law directed the FDA to ensure that drug risk information is displayed “in a clear, conspicuous, and neutral manner.”
The FDA always requires advertisements to provide the following information: balanced picture Both benefits and risks need to be considered, and this requirement saturday night live”
But in the early 2000s, researchers began showing how companies could manipulate images and audio to de-emphasize safety information. As an example, a Duke University professor found that an ad for the allergy drug Nasonex that featured the sound of a bee’s buzzing, voiced by Antonio Banderas, distracted viewers from hearing information about side effects and was memorable. I discovered that it was difficult.
Such overt tactics have largely disappeared from drug advertising.
“In general, I would say advertising has become more complete and transparent,” says Ruth Day, director of Duke University’s Medical Cognition Lab and author of the Nasonex study.
Mr Day said the new rules were a “significant step forward”, but certain requirements could open the door to new ways to downplay risks.
Information overload?
One of the requirements instructs companies to display text about side effects on screen while the audio information plays. A 2011 FDA study found that combining text and audio improves memory and comprehension.
But the agency is leaving it up to companies to decide whether to display a few keywords or the full transcript.
“Often you can’t put everything on a screen and expect people to read and understand it,” Day says. “If you want to hide risk information or make it less likely that people will remember it, you might be able to do that.”
Viewers tend to ignore long lists of warnings and other information. But experts working with drug companies don’t expect these lists to disappear. Although the guidelines describe how the information should be presented, the content is still determined by the company.
“If you’re a company and you’re worried about FDA enforcement or product liability or other potential litigation, all the incentive is to say more, not less.” Tory Cope, a food and drug lawyer who advises, says:
Experts also say the new rules will have little effect on the overall tone or look of advertising.
“The most striking elements of these ads are the visuals, and they are uniformly positive,” Cox says. “Even if the risk message is about sudden heart failure, for example, it still depicts someone jumping into a pool.”
patient influencer
The new rules come as President Donald Trump’s advisers begin considering a plan for the FDA and the pharmaceutical industry.
Robert F. Kennedy Jr.an anti-vaccine activist who advised the president-elect, wants to eliminate drug advertising on television. He and other industry commentators point out that only the United States and New Zealand allow prescription drugs to be advertised on television.
Still, many companies are looking to move beyond television and into social media. They often partner with patient influencers who post about managing their conditions, new treatments, and how the health care system operates.
“They’re teaching people to live a good life with their illness, but some are getting paid to advertise and persuade,” said Erin Willis, an advertising and media researcher at the University of Colorado Boulder.
Advertising executives say companies prefer this format because it’s cheaper than TV and consumers generally find influencers more trustworthy than companies.
The FDA’s requirements for truthful and balanced risk and benefit information also apply to pharmaceutical companies, leaving loopholes for both influencers and pharmaceutical companies. telemedicine company Like Hims, Roe, and Teledoc, they may not have direct financial ties to the manufacturers of the drugs they promote.
The issue has attracted the attention of members of Congress.
“With the power of social media and the flood of misleading advertising, too many young people are receiving medical advice from influencers rather than medical professionals,” said Sens. Dick Durbin of Illinois and Mike of Indiana.・Senator Brown wrote to the FDA in a February letter. .
Recently introduced Bill from senator This would clearly put influencers and telemedicine companies under FDA jurisdiction and require them to disclose information about risks and side effects. The bill would also require drug companies to disclose payments to influencers.
“We’re asking the FDA to take a more serious stance on this type of marketing,” Willis said. “They know it’s happening, but they could do more.”
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Education Media Group. AP is solely responsible for all content.
