Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. Dr. Robert Thompson observed that the effect of direct-to-consumer advertising (DTCA) was to consume precious time at an office visit by prompting patients to request expensive new “me too” therapies that often were not on their drug formularies. He argued that "the pharmaceutical industry should concentrate its efforts on educating physicians about its new products, not coercing patients to put pressure on physicians to make decisions that may not be necessary, beneficial or cost-effective."

A quarter of a century later, the United States remains the only country besides New Zealand where DTCA for prescription drugs is completely legal. In November 2024, a new U.S. Food and Drug Administration (FDA) rule went into effect requiring television and radio advertisements for drugs to communicate risk and contraindications in a “clear, conspicuous, and neutral manner.” On the surface, this rule aligns with the American Academy of Family Physicians’ policy that information provided in DTCA "should be accurate, balanced, objective, and complete, not false or misleading, and should not promote unhealthy or unsafe practices."

But a recent perspective in the American Journal of Preventive Medicine pointed out that the rule is silent about advertisements on online and social media platforms. It also does not change the context that most patients overestimate drug safety and that the most heavily advertised drugs have lower added benefit compared with similar medications.

To take one example, a television ad for the moderate-to-severe plaque psoriasis drug risankizumab (Skyrizi) was ubiquitous during the just-concluded National Football League regular season and playoffs. On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Dr. Livingston explained that the ad misleads viewers about the indication and cost of risankizumab:

It shows a psoriatic lesion involving less than 1% of body surface area (BSA). Drugs like risankizumab are only indicated for moderate (3-10% BSA) or severe (>10% BSA) plaque psoriasis. Viewers of the ad might believe this drug can be used to treat small, isolated lesions. They will be influenced by the visuals and are not likely to understand that risankizumab should only be used for more severe disease than is shown in the ad.… The ad states that patients may pay as little as $5 per dose, 4 times per year.… The price on the website is even better: $0 per dose. Who could blame a patient for believing the drug doesn’t cost much. If it did, why give it for free? But it is not free. Rather it is one of the most expensive psoriasis treatments available. Who pays? All of us.

A 2023 commentary in BMJ Evidence-Based Medicine contended that DTCA may "encourage patients to self-diagnose or to misinterpret their symptoms, contributing to often unnecessary diagnostic testing and the twin risks of overdiagnosis and overtreatment."

Potential reforms short of making DTCA illegal in the United States include legislation requiring manufacturers to include drug prices in ads and Secretary of Health and Human Services Robert F. Kennedy, Jr.’s previously stated intention to ban DTCA from television. However, the DTCA bill has repeatedly died in every Congress since 2019, and executive action on DTCA would almost certainly prompt a First Amendment court challenge by pharmaceutical companies.

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This post first appeared on the AFP Community Blog.