Side Effects May Include

If Trump and RFK, Jr. have their way drug ads on TV may be DOA

I don’t write those obnoxious drug ads you see on TV with their litanies of side effects recited over images of smiling, active—and, above all, alive patients. The professional side of the business is where the real money is, and why people like me who can spin data into gold are paid big bucks. Pharmaceutical companies spend $30 billion a year pitching their drugs to doctors, three times more than the $10 billion they spend advertising to you, the ultimate drug consumer.

Not that $10 billion isn’t a shit load of money.

But that may be about to change. Seeing Crohn’s disease sufferers happily sailing the high seas miles from the nearest bathroom, or the proudly bare elbows and shoulders of women with psoriasis on the beach, or people out enjoying time with loved ones despite their cancer or COPD may be a thing of the past.

In early September, Trump signed a memorandum directing the FDA to crack down on direct-to-consumer (DTC) drug ads. The memo was applauded by the FDA Commissioner Marty Makary—whose name I can’t help but misread as “Marty Malarkey.” RFK, Jr. piled on, declaring: “Pharmaceutical ads hooked this country on prescription drugs. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

Our Secretary of Health and Human Services apparently thinks that medicines are to blame for rising rates of chronic disease.

Yet, setting aside the possibility that our nation’s leaders are trying to kill us off, I’ve been wondering whether we all might feel a little better if DTC drug ads were taken off the air.

Pharma CEOs say these ads educate the public about their health and the benefits of new medicines, but the real bottom-line goal of the ads is to grow the market for their drugs by recruiting prospective patients to take them and stay on them for as long as they live, however long or short that may be.

My first job in pharmaceutical advertising in the mid-1990s was working on Invirase, one of a new class of medicines called HIV protease inhibitors that became the cornerstone of the drug cocktails that transformed AIDS from a death sentence to a chronic disease. We did DTC print advertising for Invirase, but FDA regulations, then and now, require drug ads in magazines or newspapers to include a page or more of “fair balance,” describing in detail who should and who shouldn’t take the drug, how it should be taken, all its side effects, and any warnings and precautions pertaining to its use.

Now, RFK, Jr. and company are demanding that drugmakers provide the same kind of extensive fair balance on television, radio, and social media DTC ads. They’re not declaring an outright ban but requiring copious safety information on a 30-second TV spot or social-media post would be the death knell of DTC drug ads as we know them.

But are DTC ads, however annoying, really doing anyone any harm?

Until 1997, only print ads with full fair balance like those we did for Invirase were allowed. But that year the FDA issued a new “Guidance for Industry” that permitted television and radio ads to use a more concise “brief summary” of a drug’s risks.

Physicians and public health advocates fiercely opposed the decision, arguing that it would promote overprescribing on the part of doctors and overmedication on the part of patients who didn’t need the drugs. And there was no doubt that the ads boosted prescription drug sales. A few years after the FDA loosened the rules to permit DTC ads on TV, a survey conducted by Prevention Magazine concluded that over 62 million consumers had talked to their doctors about advertised medicines, 16 million of whom had asked for an advertised medicine by name. And often as not, doctors complied with their requests.

However, the FDA found no evidence that the ads led to an increase in inappropriate prescribing. What they found instead was that DTC advertising had a generally salubrious effect, increasing awareness about treatment options, enhancing patient-physician communication, and empowering us to be more involved in our healthcare decisions. If anything, the agency found that increasing disease awareness and encouraging people to see their doctor was important because many chronic illnesses, including heart disease, cancer, diabetes, and depression continue to be underdiagnosed and undertreated.

In 2001, Nancy Ostrove, the Director for Risk Communication at the FDA testified before a Senate committee: “At present, FDA is not aware of any evidence that the risks of DTC promotion outweigh the benefits.”

And so, it has remained. Until now.

Pharma marketers are frantically huddling with their lawyers trying to figure out how to respond to the new FDA demands, but it’s unclear what, if anything, will ultimately happen. If the ads are not deceptive—the only kind of ads FDA regulations permit—they’re protected by the first amendment, no matter how annoying they might be.

Meanwhile, the Pharma lobby is dumping tens of millions into the campaign coffers of every Republican running for reelection in 2026, on whom Trump’s hold on power depends. Stay tuned. But if you don’t see any drugs ads on TV tonight you’ve probably fallen asleep with your set on.