DTC Advertising Of Prescription Drugs In The U.S. Often Promotes Products With Comparatively Low Therapeutic Value
“Ask your doctor” is the catch phrase at the end of every direct-to-consumer advertisement for … [+] prescription drugs.
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Anyone who watches television in the U.S. must notice how saturated the airwaves are with prescription drug spots. In the late 1990s, when I returned from living in Europe for more than 15 years, I was quite surprised by all the commercials for prescription drugs.* And that was when there was comparatively little direct-to-consumer (DTC) advertising of pharmaceuticals.
From 1997 to 2016, DTC advertising increased nearly five-fold, with television accounting for roughly two-thirds of total expenditures. Almost all advertising is for brand-name drugs. And, practically every commercial ends by encouraging those watching to “ask your doctor” about the product being advertised.
DTC advertising of prescription drugs is ubiquitous in the U.S. Not just on television. It’s online, on the radio, on billboards, and in magazines and newspapers, promoting treatments for pain, arthritis, cancer, heartburn, flu, deteriorating memory, and dermatological disorders, among other things. Skin conditions, such as (plaque) psoriasis and eczema, seem to be favorites these days. The brand names Skyrizi, Cosentyx, Otezla, Rinvoq, and Dupixent feature prominently in television commercials nowadays.
It’s obvious that DTC promotion of prescription drugs is supposed to alert consumers to the existence of new drugs and the conditions they treat. In this way, it can be informative; perhaps even “empowering,” as drug companies suggest. But, many doctors believe that DTC advertisements confuse patients about the relative risks and benefits of prescription drugs. Moreover, DTC advertising isn’t merely about informing consumers. It’s ultimate aim is increasing demand and raising sales revenues.
Plaque psoriasis is just one example of how successful such advertising has been in generating sales in the U.S.. At $10.4 billion, the U.S. accounted for roughly 45% of worldwide psoriasis drug sales in 2021. The disproportionate usage of psoriasis drugs in the U.S. raises questions about the degree to which prescriptions of drugs for this indication are necessarily appropriate.
Critics of DTC advertising have long argued that the practice contributes to the (over)use of higher-cost drugs over generics and less expensive alternatives.
To test whether frequently advertised branded drugs represent significant advances over existing treatments, researchers from Yale, Harvard, and Dartmouth assessed the therapeutic value of drugs subject to the most direct-to-consumer television advertising from 2015 to 2021.
For each drug indication, researchers obtained therapeutic value ratings from health technology assessment agencies in Canada, France, and Germany. These entities determine ratings based on factors such as the drugs’ added therapeutic benefit (which incorporates multiple measurable dimensions), safety profile, and strength of evidence, as compared to existing therapies.
Fewer than one-third of the most commonly advertised drugs were rated as having “high therapeutic value,” defined as providing at least moderate improvement in clinical outcomes relative to existing treatment alternatives.
Conspicuously, drug manufacturers’ television advertising spending on products rated as having “low therapeutic value” was $15.9 billion from 2015 to 2021.
The Food and Drug Administration (FDA) regulates DTC advertising by ensuring that the information contained in advertisements is not “false or misleading” and presents a “fair balance” of drug risks and benefits, along with a summary of the risks – including contra-indications – as described in the drug’s labeling.
The FDA does not require that drug companies submit advertisements for approval. But, the FDA does conduct follow-up monitoring of all DTC advertisements once they’re broadcast or disseminated.
Over the years, the FDA has issued many warning letters to drug makers, particularly regarding imagery presented in commercials. Theoretically, if an advertisement is in breach of the law, the FDA can take enforcement action, which may include court-enforced bans or even criminal charges against a drug company. Yet, evidently DTC advertising hasn’t run afoul of the authorities nearly to the degree that off-label use promotion has. The Department of Justice has imposed massive fines on violators who misbranded products or promoted off-label use prescribing through physician detailing.
The American Medical Association has repeatedly called for more restrictions on DTC advertising. But, given the constitutional protections afforded such advertising it will be extraordinarily difficult to return to the pre-1997 era.
Even relatively minor changes to the current framework for DTC advertising of prescription drugs have been nullified on the grounds that forcing drug makers to include certain information would limit commercial freedom of speech. For instance, the Trump Administration attempted to require that drug makers disclose list prices in television spots. But, a court injunction followed.
Thus, any move now to limit DTC advertising is unlikely to get very far. So, legally there’s nothing that can be done about the intense promotion to patients of drugs with relatively low therapeutic value as long as companies comply with the FDA’s rules.
Nevertheless, it may be useful as an antidote of sorts for an academic group (or some independent entity) to systematically tabulate and publicly post findings on the list price, availability of treatment alternatives, and an ordinal ranking of the therapeutic value of drugs that are heavily advertised. It can’t hurt to have a better informed public.
