Aaron S. Kesselheim is a primary care physician, lawyer, and professor of medicine at Harvard with expertise in pharmacoepidemiology and pharmacoeconomics.
Pharmaceutical ads in the United States are annoying. Absurd. And almost uniquely American.
In fact, only one other high-income country in the entire world—New Zealand—allows prescription drug companies to advertise directly to consumers. Everyone else has decided the downsides aren’t worth it. So why hasn’t the U.S. stopped them?
From the get-go, RFK Jr. has named eliminating pharmaceutical ads as one of his goals. And believe it or not, I’m with him on this one. (Gasp!) But can the administration actually take action? They think they can. Yesterday, a new executive memo and an accompanying FDA press release claimed to step up enforcement against drug ads.
Here are answers to the top 9 questions.
- Why are prescription drug ads even allowed here?
The story goes back to 1938, when Congress passed the Food, Drug, and Cosmetic Act. For decades afterward, most assumed this law made it illegal to advertise prescription drugs directly to consumers. Why? Because no advertisement could possibly provide a full and complete description of a drug’s benefits and risks. Thus, ads would inevitably misbrand medicines.
But in the 1980s, the FDA decided that wasn’t exactly true. The agency concluded that drug ads were legal as long as they included a “brief summary” of the FDA-approved drug label. That’s when glossy magazine ads took off—big splashy photos on one page, with tiny print summarizing risks on the next.
In 1997, the FDA made another pivotal change: on TV and radio, drug makers no longer needed the entire summary. Instead, they could provide a “major statement” of key risks. That’s the moment the modern era of pharmaceutical commercials began.
- Do drug ads make medicines more expensive?
Not directly. Brand-name drugs are expensive in the U.S. because we allow manufacturers to set whatever price they want. Unlike in most other countries, the government does not negotiate those prices up front. Then, once a drug is on the market, companies can hike prices at will.
But ads do shape what drugs patients ask for, and those tend to be the most expensive ones.
Generic manufacturers rarely advertise because they face what economists call the “free rider” problem. Multiple companies make the same generic pill. If you ask your doctor for a generic, your pharmacy will give you whichever version is in stock, not a specific brand. That means an ad from one generic company might boost sales for its competitors, too. Why bother?
As a result, nearly all drug ads are for costly brand-name drugs. That means patients who respond to ads often end up paying for these expensive drugs, even when a cheaper, equally effective generic or even a non-drug treatment exists.
- Have the number of ads increased over time?
Yes, particularly to patients (or consumers) compared to physicians. One study found that between 1997 and 2016, direct-to-consumer ad spending jumped from $2.1 billion to $9.6 billion. Today, drug manufacturers pour roughly $6 billion a year into these ads, most of it concentrated on top-selling brand-name drugs—and not necessarily the best brand-name drugs, either. (continued on page 2 or here)
Figure from Medical Marketing in the United States, 1997-2016 in JAMA. Source here.
Another study found that fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high added value for patients.
- Why do ads spend half the time listing side effects?
It’s required. When the FDA opened the door to TV ads in the late 1990s, they did so with strings attached. Companies had to include a “major statement” of key risks.
On top of that, drug ads must provide “fair balance,” meaning the positives and negatives have to both be presented. In practice, this usually means the first half of the commercial shows people frolicking on beaches, while the second half is a dizzying recital of warnings.
- Are drug ads misleading?
The short answer: sometimes.
The FDA’s Office of Prescription Drug Promotion (OPDP) is supposed to make sure ads are accurate, not misleading, and fairly balanced. But here’s the catch: companies don’t have to submit ads for approval before airing them. When OPDP does find problematic ads, it’s often months after they’ve gone public.
And what counts as “misleading” isn’t always straightforward. Take an ad that promotes a new sleep medicine that helps people “fall asleep quickly.” That sounds impressive until you learn that in the trial leading to the drug’s FDA approval, patients taking the drug fell asleep within 30 minutes, while people taking placebo fell asleep within 45 minutes. Not a big difference. Is the ad technically misleading? Hard to say.
Psychology complicates things further. Studies show that when drug risks are read aloud while soothing images play in the background, viewers are distracted from the serious information. The ad meets the rules, but the impact on patients is another story.
- Do these ads actually help patients?
This is a complicated question.
On one hand, drug ads increase prescribing of the featured medicines. One can imagine a case in which that is good. Patients who might otherwise suffer in silence, for example with erectile dysfunction or depression, might be encouraged to start conversations with their doctors. In theory, ads can empower people to seek treatment for stigmatized conditions.
On the other hand, ads can drive “over-prescribing.” If a patient walks into the doctor’s office and asks for a drug by name, studies show they’re more likely to get it, even if a different approach might have been better. This has raised concerns about ads fueling unnecessary or inappropriate use, especially for conditions like adult ADHD, dry eyes, or adjustment disorder.
The truth is, drug ads are a mixed bag. They can open doors to care but likely, more often than not, encourage expensive and even unnecessary prescriptions.
- Could the U.S. ever ban these ads?
Banning drug ads would be hard to imagine in the U.S. for multiple reasons.
The biggest is the First Amendment. A ban on drug ads would have to be defended in court, since pharmaceutical companies would immediately sue to overturn the ban. But the Supreme Court has interpreted the First Amendment’s protection of freedom of speech to cover commercial entities, even though businesses are not people. Unfortunately, changing the courts’ current perspectives on commercial speech is hard to envision short of a Constitutional amendment that clarified that corporations are not people and do not deserve similar speech protections.
So, if not a ban—and in the absence of a voluntary agreement by the drug companies to stop advertising—the government could try to regulate drug ads more tightly. For example, the FDA could create rules about their content or where and when they can be shown. Online ads, in particular, may have features that make them prone to misinterpretation—for instance, how risk information is displayed or how distracting design elements (like autoplay videos or pop-ups) might affect understanding. The FDA could try to identify such situations and establish rules to address them. Congress could also provide more resources and authority to the FDA to spot problematic ads quickly and remove them from circulation.
- Why hasn’t this been accomplished before?
In one word: lobbying.
The pharmaceutical industry has the most powerful and well-resourced lobbying organization in Washington D.C. It has historically opposed any efforts that would restrict manufacturers’ ability to advertise broadly because, as noted above, drug ads help brand-name manufacturers make money. The industry has provided substantial funds over the years to many of the legislators and helped elect presidents who have defined the FDA’s agenda and funding.
- So does this FDA proposal have teeth?
The new directive sounds tough, but in practice it doesn’t have much bite. As with drug ads themselves, it is important to read the fine print!
Key steps included in the directive are:
Stricter enforcement: The FDA reportedly plans to issue about 100 cease-and-desist letters and “thousands” of warning letters about drug ads.
Closing a loophole: In their major statements of drug risks, TV and radio ads have long been allowed to list only the “most important” risks if they point viewers to a website or phone number for more details. The administration says this “adequate provision” rule isn’t sufficient and wants more risks spelled out directly in the ads, even if it makes them a little bit longer.
Expanding oversight: Regulators are being directed to pay closer attention to how drug ads appear on social media platforms.
The impact of these moves will likely be limited. Warning letters nearly always just result in the company withdrawing or adjusting the advertisement without any fines or additional penalties—oftentimes months after the ad has already been widely disseminated. With recent cuts to the personnel and budget at the FDA, consistent and aggressive oversight of social media will also be hard to sustain. The directive does not even try to provide details about the so-called expanded oversight, such as essential guidelines about what should and should not be permitted in social media advertising of drugs. Such details have been needed for many years (and still do)!
Bottom line
Drug ads are a limited and inherently problematic way to inform people about prescription drugs. We need to do a much better job of empowering patients to get the medical care they need and to educate patients about the true benefits and risks of prescription drugs in an unbiased way.
Whether this ever changes will depend not just on one administration, but on how we as a country decide to balance corporate power, commercial speech, and the health of our citizens.
Love, YLE and AK
