The US Food and Drug Administration (FDA) commissioner Martin Makary has described the current state of direct-to-consumer pharmaceutical advertising as a “public health crisis” in the US, citing lax regulatory enforcement by the agency on pharmaceutical companies.
In a letter published in peer-reviewed medical journal JAMA, Makary said advertisements for prescription drugs must present a “fair balance” of risks and benefits, as per federal law.
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The viewpoint comes several days after the FDA announced it will clamp down on pharmaceutical companies and social media influencers who are responsible for misleading drug advertising or deceptive marketing.
The enforcement drive comes from the very top – US President Donald Trump said that a gradual weakening of FDA requirements for drug ads has meant the public can be misled about risks and benefits of certain drugs. He says this, in turn, can lead to the encouragement of medication over lifestyle changes and pushing expensive branded products over cheaper generics.
Makary declared that the FDA is “taking action to correct decades of regulatory failure.”
“The agency is now transitioning from reactive, complaint-driven oversight to proactive monitoring of pharmaceutical advertising across all media platforms,” he added.
The FDA chief pointed to the hundreds of enforcement letters sent annually by the agency to companies violating advertising regulations in the 1990s.
“By 2023, this number had plummeted to just one letter. In 2024, the FDA did not send a single enforcement letter,” Makary claimed.
The US is the only country besides New Zealand that allows direct advertising of prescription drugs to consumers. In the US, this has created a market worth billions of dollars for commercials via television, radio, and billboards, among others. The FDA is not able to outright ban prescription drug advertisements as this is prohibited under the First Amendment.
Makary states that “it is well established” that pharma companies spend more on advertising than research and development activities. A report by non-profit Public Citizen backs this claim, demonstrating that the manufacturers of the first 10 drugs selected for Medicare price negotiation, in aggregate, spent $10bn more on “self-enriching activities” than on research and development in 2022.
The political spotlight turned on drug advertising in the wake of a controversial advert aired by telehealth company Hims & Hers during this year’s Super Bowl final. The advert advocated for its compounded weight loss drugs while attacking rival products from Big Pharma. The commercial drew criticism from senators, while regulators said that potential side effects were not properly explained during the commercials.
Makary asserted that the Hims & Hers ad was in “breach of FDA regulation”, as the telehealth company did not mention any side effects of disclaimers. This was an example of online pharmacies being “brazen” and contributing to a dependence on prescription drugs to correct health, Makary added.
Following the news last week of the FDA enforcement drive on ads, law firm Ropes and Gray said: “In the near term, pharmaceutical companies face significant uncertainty about how to respond to FDA’s new letters and directives. For companies with broad portfolios, this blanket approach creates practical challenges in determining how to structure compliance reviews and prioritise any remedial action that they determine may be appropriate.”
Sneha Dave, executive director for Generation Patient, a nonprofit that helps young patients with rare diseases, said: “[The clampdown] is a step in the right direction toward ensuring patients receive fair, balanced, and accurate information about prescription drugs.”
