American drug advertisements are filled with dancing patients, glowing smiles and catchy jingles that drown out the fine print. It’s not education — it’s distraction by design. This is not how the practice of medicine is supposed to be.
Earlier this week, President Trump and the Food and Drug Administration took action to rein in misleading pharmaceutical ads targeted at consumers. An existing F.D.A. regulation states that ads must not create a “misleading impression,” and that ads must offer a “fair balance” between a drug’s benefits and risks. But many ads today do not abide by these standards. In fact, the most common message seems to be that a drug will instantly transform you to be singing and dancing endlessly.
For far too long, these ads have distorted the physician-patient relationship and have created increased demand for medications regardless of whether they are appropriate for the patient.
It used to be that the F.D.A. properly enforced the regulations governing pharmaceutical ads and, as a result, pharmaceutical ads were rare. But over time, the F.D.A. has become too lax. In the past, the F.D.A. office charged with overseeing drug advertising sent more than 100 warning letters to pharmaceutical companies each year. But those numbers have dwindled. In 2023, the F.D.A. sent just one warning letter. And last year, it sent zero.
It’s not just ads on television that are creating a misleading impression. Increasingly, social media influencers are paid to promote pharmaceutical products, often with no mention of side effects. A 2024 review in the Journal of Pharmaceutical Health Services Research found that many pharmaceutical ads on social media concealed risk information.
Equally brazen, online pharmacies are advertising drugs with only upsides mentioned, which can contribute to America’s pill-popping culture. This breach of F.D.A. regulation was most overt earlier this year when Hims & Hers ran a Super Bowl ad parading the benefits of GLP-1 drugs without any mention of side effects.
The F.D.A. is taking action. Earlier this week, the agency sent approximately 100 cease-and-desist letters to pharmaceutical companies whose ads were found to violate the law. This includes several online pharmacies. The F.D.A. also sent thousands of letters to companies warning them to remove ads that violate the law and alerting them to our new diligent enforcement posture going forward.
The F.D.A. is also initiating rule-making to close a loophole that has allowed pharmaceutical ads to hide safety information. Until 1997, pharmaceutical ads were required to report full contraindications and common precautions in advertisements. During this time, pharmaceutical broadcast ads were relatively rare because of the time it would take to read safety information. Since 1997, pharmaceutical companies have used what is known as the adequate provision loophole to include safety information in a website link or phone number. In this period there was an explosion of broadcast ads without full patient disclosures, which has led to negative ramifications for Americans’ health.
As a physician, I’ve had patients walk into my office to ask about medicines they saw advertised. Rarely did the patient actually meet clinical criteria for the drug, but sometimes I would learn that they got it anyway from another source. The very existence of direct-to-consumer advertising speaks volumes about how little drug companies trust that doctors are presenting patients with all their options. The ads are also generally limited to expensive medications, not generic or biosimilar alternatives that are orders of magnitude less expensive. The United States leads the world in drug spending. A nonstop bombardment of ads encouraging medications over lifestyle changes is not a path to making America healthy again.
Pharmaceutical companies may spend up to 20 to 25 percent of their budgets on advertising and marketing, according to some estimates. A 2023 study in the Journal of Public Economics estimates that direct-to-consumer advertising drove about 31 percent of the rise in U.S. drug spending since 1997, when the F.D.A. relaxed ad restrictions.
When Senators Bernie Sanders and Angus King introduced the End Prescription Drug Ads Now Act this past June, they were part of a growing bipartisan chorus demanding action on direct-to-consumer pharmaceutical advertising. The concern transcends party lines — from Mr. Sanders’s progressive coalition to efforts backed by Republicans, such as Senator Roger Marshall’s push to target deceptive online drug ads, and Senator Josh Hawley’s proposal to eliminate tax deductions for prescription drug marketing to consumers.
Whether driven by patient protection concerns or fiscal responsibility principles, lawmakers across the political spectrum recognize that America’s unique position as one of only two countries allowing widespread prescription drug advertising demands serious reform. There have been many efforts to rein in pharmaceutical ads, but none have worked — ads are more prevalent today than ever.
Over the last several years, drug companies have increasingly gamed the system. Those days are over. We are taking drug marketing claims seriously and making our regulatory standards transparent. We are restoring honesty and accountability in drug advertising to protect patients and rebuild public trust. The billions of dollars drug companies spend on advertising would be better spent on lowering drug prices for American consumers.
Marty Makary is the commissioner of the Food and Drug Administration. Before joining the F.D.A., he was a surgeon at Johns Hopkins University School of Medicine.
Source photographs by Cyril Gosselin and dowell/Getty Images
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