Prescription drug ads are everywhere. Is the ‘ask your doctor’ era over?

It’s rare to make it through an episode of your favorite show without seeing a commercial for a prescription drug that includes a lengthy list of side effects and a prompt to speak with a doctor.

And while these familiar direct-to-consumer ads have been on TV since the 1980s, today’s drug marketing now extends farther than ever before, thanks to targeted social media, online pharmacies, and influencers paid for their endorsements. Moreover, the demand for weight loss drugs allowed for compounded versions of GLP-1s—those mixed and promoted by pharmacies, rather than pharmaceutical companies—and related ads to proliferate, even though compounded drugs aren’t FDA approved. Should these tactics be more closely regulated? What happens when patients can access prescriptions without ever actually speaking to a healthcare provider?

 A new legal analysis published in the health policy journal Milbank Quarterly examines whether the rules for direct-to-consumer pharmaceutical marketing have kept up with today’s information environment and prescribing practices. 

The researchers evaluated laws, regulations, and court cases related to the First Amendment’s protection of commercial speech; the imperfect oversight of the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and states; and the changing role of prescribers in the face of aggressive prescription drug marketing.

“Our analysis is especially timely given the evolving political landscape and bipartisan support for protecting patients from deceptive drug ads,” says Jennifer Pomeranz, an associate professor of public health policy and management at NYU School of Global Public Health who worked as a pharmaceutical defense lawyer early in her career.

NYU News spoke with Pomeranz—who led the analysis with colleagues at Harvard Law School and Tufts Friedman School of Nutrition Science and Policy—about the regulatory gaps and what can be done to close them.

How does the US differ from other countries when it comes to direct-to-consumer drug advertising?

New Zealand and the United States are the only high-income countries that don't ban direct-to-consumer marketing of pharmaceutical products. We’re an outlier for two main reasons.

One has to do with US support for industry. The United States is very supportive of big corporations and we historically—and increasingly—have put corporate profits over public health.

 The second is the First Amendment, which protects speech. In the 1970s, the Supreme Court determined that the First Amendment also protects commercial speech like advertising and labeling. The courts—and the Supreme Court, specifically—have moved away from the concept that the government can restrict truthful advertising. Restrictions that can pass scrutiny have to deal with false, deceptive, or misleading commercial speech. 

Because of this, it's difficult for the US government to ban speech, where in other countries, there is a long history of protecting the public from corporate practices and speech—for instance, not allowing fossil fuel companies to advertise to the same extent as other companies.

Who’s in charge of regulating drug ads, and have they kept up with the changing media landscape?

Congress gave the FDA the authority over prescription drug advertising in the 1960s, and direct-to-consumer ads began airing on TV in the 1980s. The FDA requires ads to present a balance between risks and benefits and to include statements about side effects and contraindications.

It’s important to note that the FDA sees ads at the same time we do. There's no requirement for companies to submit ads before they air. In fact, the FDA is not allowed to require a company to submit an ad in advance. I think that should change. The FDA should have the authority—and the resources, through user fees—to require companies to submit ads before they are shown to the public.

As things have evolved, the FTC also gained a role in regulating direct-to-consumer ads related to influencers and unsubstantiated claims. The FTC has guidance documents on how social media influencers can ethically and legally advertise, including clearly disclosing their material connections to companies.

The FDA also has draft guidance focusing on social media, but it’s outdated—it doesn't cover influencer communication or video content, only static messages.

The FDA is behind and needs to update and finalize its guidance documents. But here's the problem: many entities are engaged in direct-to-consumer marketing but don't fall under the FDA's authority. For instance, influencers who seek a financial relationship with companies or who are patients and tout products but don't have a relationship with the pharmaceutical company wouldn’t be under the FDA’s authority.

How do current regulations put the onus on doctors to communicate risks to patients?

In US law, a company that makes a product has the duty to warn consumers of risks and dangers of the product. But in the context of prescription drugs, under a legal principle called the “learned intermediary doctrine,” pharmaceutical companies are shielded from this liability as long as they adequately warn prescribers of the risks. The idea behind it is that, unlike lay people, healthcare providers have the education, skills, and knowledge to assess a drug’s risks. Yet, remember, the pharmaceutical companies are advertising to consumers who lack this very foundation. 

In other words, for prescription drugs, the responsibility is shifted from the company to the doctor: companies are responsible for warning healthcare providers, and the onus is on providers to advise their patients of the benefits and risks. As a result, consumers have little recourse if they’re misled by direct-to-consumer ads.

Some states have established exceptions to the learned intermediary doctrine. For instance, a Massachusetts court held that it doesn’t apply to birth control pills, given that patients almost always request them and are actively involved in the decision to use them. In cases in New Jersey and West Virginia, the courts determined that the learned intermediary couldn’t apply because of how heavily drugs were marketed to consumers, although the West Virginia legislature later enacted a law nullifying the court’s decision.

So has the learned intermediary doctrine outlived its usefulness?

In some ways, definitely yes. The learned intermediary doctrine provides perverse incentives to companies to aggressively market their drugs without consequence. The doctrine was created by a state court in the 1940s, decades before direct-to-consumer advertising and drug commercials filled our TV screens. Our work shows that the learned intermediary is based on outdated concepts and should be reconsidered by state legislatures and courts.

Say you go to the doctor with an infection. The role of the healthcare provider is to know which antibiotic goes with which infection. You might ask for an antibiotic, but you wouldn’t know which one you need, so it makes sense that there’s a learned intermediary in this case.

But today’s marketing landscape is so far removed from that scenario, with so many pharmaceutical companies engaging in robust direct-to-consumer marketing. The learned intermediary works in the case of antibiotics, but it doesn’t work when drugs, like GLP-1s, have been aggressively marketed to the public. 

This is a great time to end the concept of learned intermediary—at least for highly marketed drugs—and for states to consider passing legislation saying that drug companies informing prescribers does not shield them from liability. 

Have telehealth startups and online pharmacies shifted how we think about the dynamic between prescribers and patients?

The learned intermediary doctrine as well as court cases striking down government restrictions on direct-to-consumer advertising are all based on a traditional and antiquated notion that patients are seeing doctors and dialoging with them. Thanks to telehealth and online pharmacies, you don't actually have to meet with a doctor—in some states, you can just fill out an online questionnaire, without a physical examination, video, or telephone interaction with a provider.

Given the First Amendment, the government would need to regulate questionable online prescribing practices themselves rather than their advertisements, but compelling arguments can be made that state legislatures and courts should additionally evaluate the relevance of the learned intermediary doctrine in light of the changing role of provider-patient interactions.

Let’s talk about GLP-1s. How have these popular weight loss medications exposed gaps in drug marketing oversight?

Similar to birth control, most weight loss drugs are requested by patients. GLP-1s are a perfect example of where that exception to the learned intermediary doctrine should lie.

In recent years, when consumer demand for GLP-1s exceeded supply, resulting in shortages, compounders were allowed to make and sell compounded versions of these drugs. Compounding used to be a niche practice, but the rapid growth of GLP-1s seems to have brought it to the surface, and these companies are now engaged in extensive direct-to-consumer marketing. 

It’s important to note that compounded drugs are not regulated by the FDA—states regulate compounding because it is considered a pharmacy practice. Further, our research shows that FDA oversight of the marketing of compounded drugs is a “regulatory gray area.” There are so many holes in the regulation of compounding in general that the marketing is falling into this abyss—no one seems to really be overseeing it.

What regulatory changes would help to address the gaps with compounded drugs?

Congress should provide the FDA with equal authority over compounded drug safety, efficacy, quality, and promotion as it has for other prescription drugs and prescription drug promotion. But in the absence of that oversight, the FTC and the state attorneys general can play a larger role than they're playing.

The FTC has authority over deceptive, unfair consumer practices. States also have consumer protection statutes. State attorneys general could bring actions against compounders for failing to provide risk information and truthful statements about how well drugs work. 

Erika Hanson of Harvard Law School and Dariush Mozaffarian of the Food is Medicine Institute at Tufts co-authored the article with Pomeranz. Their research was supported by the National Institutes of Health (NHLBI 2R01 HL115189).