By Joseph Walker and Suzanne Vranica

The surreal world of TV pharmaceutical ads, where people with terrible diseases tend to be young, beautiful and living life to the fullest -- sometimes with animated monsters -- has been parodied on late night sketch comedy shows.

But the drug industry's biggest critic may turn out to be government regulators inside the Food and Drug Administration.

The FDA is cracking down on direct-to-consumer ads on the directive of President Trump. The agency issued letters to drugmakers last week, citing misleading storytelling with embellished scenes of picture-perfect health. Companies should cease and desist airing misleading ads, which violate federal law around the marketing of prescription drugs, the agency said.

In a letter to Bausch Health, regulators took issue with an ad for the toenail-fungus treatment Jublia. The ad shows a young, muscular man embarrassed when his yoga instructor notices his fungal infection, which is depicted as a large, hairy "Bigfoot foot." Another woman in the class moves away from him while rolling her eyes.

But his smiling yoga instructor comforts him: "I had it too. My doctor prescribed a topical treatment." The man looks up Jublia on his laptop; a Bigfoot figurine is visible on his desk. He is shown applying the treatment and is soon back in yoga class, his skin is clear and his hideous Bigfoot foot is gone.

The commercial "creates a misleading impression that all patients, once treated with Jublia, can expect a complete cure, when this has not been demonstrated" in studies, the FDA wrote. Clinical studies showed a complete-cure rate of less than 20%.

"The claim, 'don't fear the fungus' minimizes the condition," the FDA writes, "creating an implication that it is easily treated and cured with Jublia and the condition should not be feared by patients."

A Bausch spokeswoman declined to comment.

The FDA crackdown represents the most significant increase in the agency's scrutiny of drug ads in years. The FDA sent 100 letters notifying companies that their ads were out of bounds, compared with just a handful of letters in the past two years.

A Department of Health and Human Services spokesperson said the FDA's "vigorous enforcement against false, misleading, and deceptive advertisements" is a correction to the decline in agency attention to DTC marketing in recent years.

Many letters dove deep into the narrative arcs and aesthetics of the television ads. In a Pfizer ad, a young man is sitting on the couch next to a blue-skinned, five-eyed creature who runs to the camera and starts licking the screen like a puppy. The man explains that "this thing" is what's happening inside of him, an inflammatory bowel disease called ulcerative colitis.

"It wasn't always this calm," he says. A flashback scene shows the creature, now blood-red, tearing through his home like a wild animal.

"But then I found out about Velsipity, a new once-daily pill," the man says, back on the couch in the present day with the more docile blue creature. The frames that follow show the relatively well-behaved creature following him around as he enjoys a barbecue with friends.

"The main character is now not bothered at all by the creature's disruptive actions," the FDA noted in a letter to Pfizer. "The magnitude of change depicted in the visuals implies a greater improvement in clinical remission than had been demonstrated" in studies.

A Pfizer spokesman said the company will respond to the FDA's letter but stands by its commitment to responsible communication and regulatory compliance. The company submitted the ad's imagery for review before airing it, the spokesman said.

The FDA's message to companies is that it wants consumers to get an accurate depiction of a drug's risks and benefits, said Edgar J. Asebey, a life sciences regulatory attorney at Frier Levitt.

"If [the ad] is overly sort of cutesy and charming and then there's just a little blurb at the end [about side effects], then probably it isn't a balanced disclosure," said Asebey.

Another departure from past practice is the agency's attention to companies overhyping their drugs' effectiveness and not just the omission of potential side effects. Informing patients of harms is only half the problem, said Dr. Steven Woloshin at the Dartmouth Institute for Health Policy and Clinical Practice who has advocated for improving the quality of information that consumers receive about medicines.

"I was pleasantly surprised to see that they were actually looking at the claims in these broadcast ads and trying to correlate them with what the evidence actually showed," said Woloshin. "People have been aware for a long time that the ads seem to overpromise."

In an ad for AstraZeneca's asthma drug Fasenra, a tablet computer shows a video of a young woman lying on the couch alone at home, laid low by her asthma. On-screen text says "Losing my groove. Thanks, asthma." To the right, a separate video shows a lively outdoor bar. A man from the bar reaches into the other screen and pulls the woman into the bar and soon they are salsa dancing. It ends with her and her partner taking a selfie that is posted on social media, as likes pop up from friends.

"The totality of these claims and presentations misleadingly suggests that Fasenra provides greater benefits to patients" than was shown in studies, the FDA wrote in its letter. "The compelling before-and-after presentations imply an improvement in social and emotional functioning" that clinical studies didn't prove, the agency wrote.

AstraZeneca declined to comment.

People are almost as likely to say they learn about new medications from an ad on TV as from their doctor, according to a recent survey. Pharmaceutical ads, which are typically longer in length because they have to include a drug's side effects, accounted for approximately 1.58 million minutes of ad time last year, second to health-and-beauty advertising, according to TV measurement firm iSpot.

The pharmaceutical industry spent nearly $11 billion in 2024 for U.S. ads, according to estimates from ad-tracking firm MediaRadar.

Pharmaceutical companies will likely tone down the creative approach of drug ads amid the crackdown, if history is any lesson, according to pharmaceutical marketing experts. Back in the mid-2000s, when there was a push to limit or eliminate DTC ads, pharmaceutical companies and ad agencies that specialized in drug advertisements started playing it safe by running TV commercials that featured talking-head doctors.

Several drug companies have already requested a full audit of their advertisements to ensure they are in compliance with FDA regulations under the agency's more aggressive policy, said one ad executive.

Some ad-industry executives were taken aback by the detailed nature of the letters, especially given the significant staff reduction at the FDA following extensive layoffs implemented under Trump's Department of Government Efficiency initiative.

The agency has made clear that drug ads are a priority of the administration, and the FDA is likely to shift resources from other areas to follow through on its commitment, said Asebey, the Frier Levitt attorney. "It's caught everybody's attention," he said.

Write to Joseph Walker at joseph.walker@wsj.com and Suzanne Vranica at Suzanne.Vranica@wsj.com

(END) Dow Jones Newswires

September 21, 2025 05:30 ET (09:30 GMT)

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