Why the FDA is Calling DTC a Public Health Crisis

Imagine watching TV or scrolling through social media and seeing an ad for a prescription drug. The ad highlights how amazing it is, the relief, the benefits, the promise of a better life but the risks? Vague. Side effects? Maybe briefly mentioned, or maybe just referenced somewhere else. That’s the world right now, and Marty Makary thinks it’s dangerous.

In a JAMA editorial published in mid-September 2025, Makary lays out a case that our current approach to drug advertising has drifted so far from careful regulation that it’s quietly compromising public health. He argues that by giving drugmakers license to highlight all the upsides of medication, while giving only a nod to the risks through “adequate provisions” buried somewhere else, we have woven a system that inflates expectations and warps the doctor-patient conversation.

That “adequate provision” rule dates back to 1997, a rule which lets pharmaceutical companies put in the ad only so much information about risk or side effects as fits into the commercial, with the rest relegated to fine print in disclosures or external resources. At the time, it may have seemed like a reasonable compromise. But according to Makary, almost immediately after the rule took hold, spending on drug advertising exploded, nearly 800% in just ten years. As ads multiplied, so did their ability to shape how people think about medicine, sometimes more as a product to desire than as a treatment to weigh.

He also points out how weak the oversight has become. The FDA’s Office of Prescription Drug Promotion, once issuing hundreds of enforcement letters a year in the late 1990s, dropped to just one warning in 2023, and none in 2024. Under Makary’s leadership, the agency has put out a few more warning letters lately, but he makes clear: the change has come far too late.

Makary isn’t calling for a ban on prescription drug advertising wholesale, that would bump up against First Amendment rights. But he believes the “adequate provision” loophole must go, because allowing drug ads to roughly point to risks (rather than clearly state them in the advertisements themselves) means that most TV or digital spots end up being more promotional than informational. In particular, Makary is critical of ads on social media and by online pharmacies where disclosures are either missing, unclear, or treated as optional. He cites recent examples like the campaign by Hims & Hers during the Super Bowl, which spotlighted GLP-1 drug products without sufficient attention to possible side effects.

What Makary wants is for the regulatory regime to shift from waiting for complaints to proactively watching drug advertising everywhere. Rather than industry-led oversight, he’s pushing for a system where the FDA actively monitors ads, makes sure risks are clearly stated, and ensures consumers aren’t misled. The goal is to protect patients, reduce unnecessary prescriptions, and redirect health care dollars toward places that actually improve care and outcomes.

What strikes me most about Makary’s argument is how it highlights a tension in our modern health culture: on one hand, we demand innovation, better treatments, more choices; on the other, we expect transparency, safety, and honesty. When those two pull in different directions, patients are the ones who bear the cost — medically, financially, emotionally.

If we want drug advertising to do more good than harm, perhaps it’s time to rethink how much promotional content we accept, and how much regulatory pushback we tolerate. The question isn’t whether drug advertising can be informative, it’s whether our current system actually makes that possible.

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