The pharmaceutical industry has spent over $1 billion a month on ads in recent years, with three of the top five spenders on TV advertising being drug companies. The FDA has tried to ensure that prescription-drug advertising gives a more accurate and easily understood picture of benefits and harms, but the results have been disappointing.
In 1997, the FDA reluctantly allowed pharmaceutical ads on TV, as long as they gave an accurate accounting of a medicine’s true benefits and risks, including a list of potential side effects. However, the FDA underestimated the wiliness of the pharmaceutical industry, which invented a new art form: finding ways to make their wares seem like joyous must-have treatments, while often minimizing lackluster efficacy and risks.
A 2023 study found that, among top-selling drugs, those with the lowest levels of added benefit tended to spend more on advertising to patients than doctors. "I worry that direct-to-consumer advertising can be used to drive demand for marginally effective drugs or for drugs with more affordable or more cost-effective alternatives," the study’s author, Michael DiStefano, a professor of clinical pharmacology at the University of Colorado, said in an email.
Indeed, more than 50% of what Medicare spent on drugs from 2016 through 2018 was for drugs that were advertised. Half of the 10 drugs that the Joe Biden-Kamala Harris administration targeted for drug price negotiation this year are among the drugs with the largest direct-to-consumer ad spend.
The US government has tried to ensure that prescription-drug advertising gives a more accurate and easily understood picture of benefits and harms. However, the results have been disappointing. When President Donald Trump’s administration tried to get drugmakers to list the price of any treatments costing over $35 on TV ads, for example, the industry took it to federal court, saying the mandate violated drugmakers’ First Amendment rights. Big Pharma won.
Last November, the FDA issued requirements that ads give consumers a "non-misleading net impression about the advertised drug." The agency stated that information had to be presented in a "clear, conspicuous, and neutral manner." Ads must avoid "audio or visual elements that might interfere with the consumer’s understanding" and "text information is presented in a way that is easy to read."
However, the language is disappointingly vague: What do "neutral" and "non-misleading" mean? Do the proscribed audio-visual elements include people hiking, or dancing to upbeat music? How quickly or slowly can the chyrons listing adverse reactions scurry across your screen? There is no FDA police force to decide how the language should be interpreted.
Common sense and the sort of truth-in-advertising standard we apply in other sectors could be a suitable first step. Take ads that promise patients with advanced cancers "a chance to live longer." A more truthful ad might say that studies are equivocal or, as the widower of one patient drawn in by an ad wrote in an op-ed article: "an outside chance for people with advanced lung cancer to live just a few months longer." And they’re not likely to be hiking or hitting the beach during that time.
With a bit of commonsense, truth-in-advertising enforcement, many of the ads would disappear. The FDA email informed me that it is working with the Duke-Margolis Institute for Health Policy and others to help "further develop" its policy and guidance documents.
Gerard Anderson, a professor of health policy at Johns Hopkins University’s Bloomberg School of Public Health, proposes that, at the very least, drug ads should be required to feature prominent warnings about risks, like those on cigarette packs. "If you see it on TV or on social media, it’s probably not as good as something else," he added. Or at least more expensive.
Conclusion
The pharmaceutical industry’s reliance on direct-to-consumer advertising has created a situation where patients are being bombarded with misinformation and manipulated into demanding unnecessary treatments. It is essential that the FDA takes concrete steps to ensure that pharmaceutical ads are truthful and accurate, and that patients are not being misled into using ineffective or harmful treatments.
FAQs
- What is direct-to-consumer advertising?
Direct-to-consumer advertising is the practice of pharmaceutical companies advertising their products directly to consumers, often through television, social media, and other forms of media. - Why is direct-to-consumer advertising a problem?
Direct-to-consumer advertising can be misleading and manipulate patients into demanding unnecessary treatments, which can lead to overuse of medications, increased healthcare costs, and harm to patients. - What can be done to regulate direct-to-consumer advertising?
The FDA can take concrete steps to ensure that pharmaceutical ads are truthful and accurate, such as requiring prominent warnings about risks and ensuring that ads are vetted before airing.
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