If you live in the United States, you’ve likely seen drug commercials like this one:
“If you’re living with moderate to severe plaque psoriasis or active psoriatic arthritis, symptoms can sometimes hold you back,” a cheery voice says as a woman sips a hot drink in her car while looking out toward the ocean. “Now there’s Skyrizi, so you can be all in with clear skin,” the voice declares in an even more upbeat tone. The woman throws off her white cardigan, revealing a blue bathing suit and unblemished limbs, before running into the ocean.
The commercial then lists some of the medication’s side effects, such as serious allergic reactions and an increased likelihood of infection. Other risks are described online: liver problems, headaches, stomach pain, low red blood cell count, and fungal skin infections. The list goes on.
But there’s another downside that’s unlisted, one that’s not associated with the medication but the TV commercial itself: Critics say such direct-to-consumer drug ads — which are prohibited in all but one other country — misinform patients and underemphasize treatment risks.
As Robert F. Kennedy, Jr. — Donald Trump’s pick for secretary of the Department of Human and Health Services — threatens to ban such ads on his first day in office, the pharmaceutical industry is sounding the alarm. A recent report by the health care technology company Intron Health found that pharmaceutical interests named the potential ban as their number-one concern with the incoming administration, saying that doing so would lead to a drop in drug sales.
“We see this as the biggest imminent threat from RFK and the new Trump administration,” Intron’s authors wrote.
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While the likelihood of Kennedy successfully banning these ads is slim, Big Pharma’s reaction to the threat highlights just how dependent pharmaceutical interests — as well as media conglomerates — have become on advertising drugs directly to consumers.
In fact, the report by Intron found that the return on investment from direct-to-consumer drug ads is incredibly high, ranging from 100 to 500 percent. For example, as of last September, AbbVie, the manufacturer of Skyrizi, brought in more than $3.2 billion dollars globally from the drug — making Skyrizi the company’s top-selling product. AbbVie is also the largest drug ad spender across the pharmaceutical industry, shelling out almost $580 million on Skyrizi alone in 2023.
Such profits come with unnecessary drug prescriptions, raising health care costs and other concerns for consumers and taxpayers alike.
“The thing that I worry about is when you have advertising of drugs, you’re not really able to provide all of the information that an informed consumer or patient would need to know if this is appropriate for them,” said Amy McGuire, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, Texas.
A Multibillion-Dollar Income Stream
During the nascent years of the Food and Drug Administration (FDA) in the early 20th century, prescription drug information wasn’t intended for the public. According to 1938 regulations, “it was expected that information in drug labels would ‘appear only in such medical terms as are not likely to be understood by the ordinary individual,’” noted a 2013 paper by researchers at the Dartmouth Institute for Health Policy and Clinical Practice.
The first direct-to-consumer drug ad appeared in print in 1981, but at the time, such advertisements didn’t really take off. That’s because the FDA required drugmakers to list every potential side effect in their advertisements — a major challenge for those aiming to make short and sweet television ads.
But in 1997, when Bill Clinton was starting his second term in office, the FDA softened its disclosure requirements for drug ads. After that, such ads only had to include “major risks” — a boon to drugmakers hoping to market their drugs on TV. Spending on ads skyrocketed by 330 percent from 1996 to 2005, reaching $4.2 billion.
This spending continued to increase over the years. Drug manufacturers shelled out $17.8 billion on advertising for more than 550 drugs between 2016 and 2018, most of which treat chronic medical conditions like arthritis, diabetes, and depression, according to a 2021 report by the congressional watchdog Government Accountability Office. These ads pay off in spades: Medicare and its beneficiaries spent $560 billion on drugs over that same time period, nearly 60 percent of which went toward advertised drugs.
In every other country save New Zealand, direct-to-consumer drug ads are prohibited in order to protect patient health. A 2023 analysis of why most countries outlaw the marketing practice found that these ads can lead to overdiagnosis and unnecessary treatments.
Direct-to-consumer ads have some upsides. The advertising has been shown to educate consumers somewhat, keep patients compliant with their drug therapy, and expand drug care to previously undertreated patients.
But there are also significant downsides. A 2020 paper by McGuire and a colleague from Baylor College of Medicine found that these advertisements increase the number of requests by patients for newly marketed medications, along with the likelihood of both appropriate and unnecessary prescribing by health care providers.
“You want to have informed consumers,” McGuire said. However, “there is this increased demand [for medications] based on direct-to-consumer advertising… and consumers either don’t have all of the information, or the physician doesn’t have the time or motivation to say, ‘Well you could go on that medication, but there is a cheaper one you could go on,’ or, ‘You might not need this medication.’”
Drug ads, which typically promote glittery new treatments, have also been associated with the use of higher-cost drugs as opposed to more affordable generics or older drugs — even though many of these new, expensive drugs are no better therapeutically than the ones that are already on the market.
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In a study published in 2023, researchers assessed the therapeutic value of 73 of the most heavily advertised drugs in the U.S. from 2015 to 2021. A high therapeutic value rating indicated that the drug provided at least a moderate improvement in clinical outcomes compared to previously available treatments.
They found that only about one in four of these advertised drugs had a high therapeutic value. That meant drugmakers spent almost $16 billion over the six-year period to advertise products that didn’t provide at least moderate health benefits compared with existing therapeutic options.
“Many consumers might assume that the drugs they see all the time on TV are for cutting-edge therapies that are groundbreaking advances over the other treatment options on the market,” Neeraj Patel, the lead author on the study and medical student at Yale School of Medicine, wrote in an email. “Our study suggests that assumption is usually wrong: Heavily advertised drugs often do not necessarily provide meaningful therapeutic benefits as opposed to other therapeutic options.”
Direct-to-consumer drug ads are not the only type of pharmaceutical marketing influencing drug promotion: Last year, health care providers received nearly $31 billion worth of free samples from pharmaceutical representatives, a strategy that some researchers say is an even larger and less regulated business than direct-to-consumer advertising.
An Uphill Battle
Regardless of Robert F. Kennedy, Jr.’s dislike for direct-to-consumer drug ads, it is relatively unlikely he will be able to follow through with his vow to fully ban them.
“Mr. Kennedy has called for an executive order,” The New York Times wrote, noting that, “Efforts to modestly restrict drug ads have repeatedly been defeated in the courts, often on First Amendment grounds.”
During the first Trump administration, a federal judge blocked a government ruling requiring drugmakers to include prices in their drug commercials, claiming it exceeded the agency’s authority. Kennedy could continue to push for cost transparency or require FDA review of all drug ads, but any such reform attempts would likely be slow-going and challenged by the industry.
Another obstacle would be overcoming Big Pharma’s lobbying army, which spent a total of $294 million lobbying last year on matters like drug ads. Most of this money came from the Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry’s main trade group. The group has spoken out in favor of direct-to-consumer drug ads and publishes advertising guidelines for drugmakers to follow.
TV and radio broadcasters would also likely fight a drug ad ban, since Big Pharma is one of the top spenders on advertising. “Pharmaceutical advertising skews toward national television, and the loss of this key vertical could hurt television,” according to a December report by the financial analytics company S&P Global.
Last year, the National Association of Broadcasters, the trade group for television and radio broadcasters, spent $8.8 million lobbying on issues including direct-to-consumer advertising, according to lobbying records.
But there are steps that can be taken to mitigate the negative impacts of direct-to-consumer advertising, said Patel, such as requiring pharmaceutical companies to include disclaimers regarding the effectiveness of the advertised drug versus already available treatments.
Additionally, experts have proposed a “Drug Facts Box” for products. Such labels would include easy-to-understand, one-page summaries of the benefits and risks of newly approved drugs.
“A series of studies — including national randomized trials — demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making,” according to the 2013 paper by Dartmouth researchers.
In 2023, the FDA required prescription drug ads on TV and radio to lay out potential side effects using “consumer-friendly language and terminology that is readily understandable.” While a step forward, these standards only apply to prescription drugs, not over-the-counter medicines, dietary supplements, or other products, each of which is the focus of hundreds of millions in advertising funding each year.
Even if all of those drug ads filling the TV and computer screens aren’t likely to go away soon, advocates hold out hope that regulators could at least require them to be more informative and comprehensible.
“I would hope that if there was heightened regulation [around direct-to-consumer drug ads], it would be really focused around making sure that there was accurate and complete information available to consumers,” said McGuire.
