The Washington PostDemocracy Dies in Darkness

The problem with direct-to-consumer pharmaceutical advertising

FDA enforcement has lagged, and with the rise of internet ads, it could put consumers at risk

(Elise Amendola/AP)
7 min

If only medicines could do everything advertisers claim.

Consider an inspiring ad for an AIDS drug, featuring a former basketball star suggesting the drug can help most or all HIV patients. In reality, however, the drug was only effective for 37 percent of patients. A prescription medication for thicker eyelashes displayed a stunning fashion model on its website, while downplaying the risk that hair could grow outside the treatment area or that the person’s eye color could be permanently darkened.

Although supporters of direct-to-consumer advertising contend that the practice provides an important educational resource to patients, research shows that advertising medicine to consumers prompts inappropriate prescriptions, increases adverse patient outcomes and boosts drug prices. The problem may loom even larger as direct-to-consumer telehealth companies and pharmacies move into the online space. A recent investigation found a new danger with quick, online access to medicine: 25 percent of the websites investigated were leaking sensitive patient information to advertising platforms.

From snake oil to opioids, advertising medicine directly to consumers has a long and sordid history in the United States. Well before modern images of talking stomachs or couples in separate bathtubs, drugmakers aggressively marketed cures for a whole host of illnesses, real and invented.

With vibrant names like Hamlin’s Wizard Oil and Dr. Kilmer’s Swamp Root, such “medicines” tended to keep their actual ingredients — often alcohol or opium — a closely guarded secret. Ultimately, the marketing prowess of the “patent medicine” industry was its own undoing, as public outrage led to increased regulation in the first half of the 20th century. But now, changes in the media landscape have allowed the practice of appealing directly to patients to take off once again — with potential to harm vulnerable communities as in the past.

The United States occupies a lonely outpost in allowing unfettered advertising of medicine to consumers, with New Zealand as the only other country that permits product claims. Canada allows more limited advertising, but most countries completely forbid advertising medicine to patients.

Drug producers in the United States have been trying to influence public opinion for centuries. In the 1800s and early-1900s, “patent medications” (often not patented, but instead made with secret ingredients) were trumpeted with full-blown campaigns marketing them as popular “cures for the people.” Coca-Cola and tonic water were originally “patent medicines,” though the modern formulations omit key ingredients once used in them, including quinine and even cocaine, extracted from the coca leaf, which gave rise to the iconic brand’s name.

Drugmakers were not required to test the safety of their products, nor was the accuracy of their medical claims verified. These conditions enabled snake oil salesmen to thrive: Tablets made of cannabis and chloroform were advertised for “women’s ailments,” a mixture of opium and alcohol was marketed to treat rabies, tetanus and “nervous irritability,” while strychnine poison was peddled as an aphrodisiac.

These solutions were not just deceptive. They were dangerous.

Public outrage about the fraudulence of “patent medicine” claims led, in part, to the 1906 Pure Food and Drugs Act. The law focused on labeling, and it marked the emergence of the Food and Drug Administration (FDA) as a consumer protection agency.

But the act’s shortcomings were tragically exposed in the 1930s when dozens of children died after taking “Elixir Sulfanilamide,” a sweetened cough syrup that contained alcohol. Following these tragedies, it was clear that more than labeling was needed. Thus, in 1938, Congress passed the Food, Drug and Cosmetics Act, which mandated safety testing for new drugs, pre-marketing approval by the FDA and beefed-up labeling requirements.

Flexing its newfound muscles, the FDA designated drugs such as sulfanilamide and narcotics as prescription-only. Over the next two decades, the resulting regulatory regime redirected consumer spending from “patent medicines” to prescription drugs. The greater number of drugs requiring a prescription meant that physicians, not patients, effectively made most purchasing decisions, and pharmaceutical companies focused largely on appealing to physicians for much of the next 50 years.

Although the FDA and the Federal Trade Commission (FTC) had overlapping jurisdiction during this period regarding medical advertising, the agencies eventually agreed that the FDA should have sole oversight for prescription drug advertising, leaving advertising of all other products primarily in the hands of the FTC. This division of labor made sense, given the industry’s focus on doctor-centered advertising.

By the 1970s, however, patient-centered medicine became more commonplace as individuals wanted to be more involved in medical decisions. Advertising companies soon capitalized on this trend and the first drug advertisement appeared on television in 1981. After asking for a voluntary moratorium on advertising drugs to consumers, the FDA eventually stipulated that advertisements to consumers must meet the same standards as advertising to physicians.

In the late-1990s, however, the FDA eased requirements for televised product claims about medicine. Specifically, the FDA’s regulations (first promulgated in 1969) required a “fair balance” of clinically relevant risks and benefits, along with communication of risks, side-effects and contraindications. The 1997 guidelines allowed companies to satisfy part of the risk information obligation by including a phone number or website address. The result is what we see today, smiling faces, soaring music and rapidly-listed risk information at the end that can easily be ignored. A “fair balance” has been lost in the shuffle.

Once the FDA provided a workable method of satisfying the regulations, spending ballooned. Although the pharmaceutical industry spent roughly $2 billion marketing to consumers in 1997, that number approached $10 billion by 2016, and now increasingly includes internet ads.

The potential for abuse may increase as companies hone their ability to target specific groups of prospective patients, in particular elderly individuals who may be more susceptible to drug advertising. Indeed, the rise of online advertising enables much greater precision for advertisers to target marginalized or vulnerable communities. A predisposition or even a worry about certain medical conditions could be extrapolated from the patient’s internet footprint (e.g., internet searching or order history), prompting a drugmaker to bombard the patient with online advertisements for a drug.

This surge of contemporary television and internet advertising has coincided with a notable drop-off in FDA enforcement, perhaps from the sheer volume of work as the agency has been asked to shoulder safety and efficacy issues for medical devices, tobacco products and dietary supplements. The FDA may simply be overwhelmed. Meanwhile, its sister agency, the FTC — which has extensive day-to-day experience regulating all manner of consumer advertising — has been sidelined in the case of advertising medicine, with its jurisdiction primarily restricted to over-the-counter drugs and “self-help” messages.

But these two agencies have the institutional capacity to work together. They have coordinated with other agencies in areas outside of prescription medication and could do so here. For example, the FDA cooperates with the U.S. Department of Agriculture to ensure food safety, and the FTC shares responsibility for merger oversight with the Department of Justice. Clearly, the FTC has the experience and regulatory structure to lead the effort, with an assist from the FDA. The FTC could gauge whether prescription drug advertisements are appropriate from a consumer communication perspective, while directing questions about safety and efficacy to the FDA for evaluation.

Other tweaks to the laws governing drug advertising to consumers could help as well. While banning the practice is worth consideration, it probably won’t occur. But lawmakers could rescind the tax deduction that drug manufacturers currently receive for direct-to-consumer advertising expenditures. At a time when legislators scramble to find sources for funding initiatives, this tax benefit could provide an option. Furthermore, boosting regulatory resources through industry user fees could help support the necessary agency effort, irrespective of which agency is at the helm.

As was the case a century ago, more comprehensive oversight of pharmaceutical advertising is warranted. If the United States is going to lead the rest of the world in allowing advertising medicine directly to consumers, its regulatory system should keep pace.