Ask your doctor about Zintruvpa! Side effects may include nausea, dry mouth, headache, and — oh yeah, sudden death.
If you’re in the U.S., chances are you’re familiar with commercials imploring you to consult with your medical provider about whether a particular medication is right for you. But these ads — which typically conclude with a quick recitation of the drug’s undesirable effects — may soon look different, owing to a new executive order by President Donald Trump.
On September 9, the administration announced plans to address direct-to-consumer prescription drug marketing, which includes advertising in print and on television, radio, and social media. In response, Robert F. Kennedy Jr., secretary of the Department of Health and Human Services, revealed that his office would crack down on misleading ads and more strictly enforce regulations about risk disclosures in drug marketing.
Before 1997, pharmaceutical companies were required to communicate the full list of a medication’s side effects in every advertisement, says Carmel Shachar J.D./M.P.H. ’10, faculty director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation at Harvard Law School.
But two decades ago, she says, the Food and Drug Administration relaxed this standard, in part out of concern for commercial speech rights. “In this loosened regulatory environment, spending soared on drug ads aimed at consumers.”
Notably, the U.S. is one of just two countries in the world that allows this type of marketing, Shachar says, which studies show is linked to the growing increase in prescriptions and prescription drug spending over the last 20 years. That’s why, despite disagreement over other aspects of Kennedy’s Make America Healthy Again agenda, Shachar believes the new policy is likely to find advocates on both sides of the political divide.
“This is an issue on which a lot of health advocates are aligning,” she says.
But that doesn’t mean that the executive order won’t encounter pushback, particularly from pharmaceutical companies, which may raise First Amendment concerns, Shachar says. In an interview with Harvard Law Today, she explains how the executive order could reshape the way drugs are marketed in the U.S. — and the thorny legal questions it might encounter.
Harvard Law Today: Have pharmaceutical companies always been able to advertise drugs directly to consumers in the United States? If not, when did this all begin?
Carmel Shachar: There are a couple important things to understand. First, every other country in the world — with the exception of New Zealand — does not allow for direct-to-consumer advertisements of pharmaceuticals. For many decades after the creation of the Food and Drug Administration, we didn’t really allow for drug advertisements either. Then, in 1981, you start seeing some advertising by manufacturers. One of these was a pneumonia vaccine that was advertised directly to consumers, and the FDA responded by stepping back and asking the industry for a yearlong hiatus so that they could study the issue.
After a year, it came back and said that the same rules that applied to advertising to physicians would apply to direct-to-consumer advertising. During this time period, you get some advertising, but because companies must explain all of the side effects of the drugs, they find it difficult to advertise on television. In print, there’s room at the bottom for the tiny writing required to describe everything, but it’s very hard in a 30-second TV commercial to cover all of that information. 1997 is a turning point, because that’s when the FDA issues new regulations saying that pharmaceutical companies don’t need to include all of that information — just a brief summary, and a way to refer people to a place where they can get the rest of the information. From then onwards, there’s a real explosion in advertising dollars spent on pharmaceuticals.
HLT: What was the status quo in this type of advertising leading up to last week’s executive order?
Shachar: It was a permissible regulatory scheme that took the approach that, presuming there is a way for patients to access the full information about the drug, advertisers don’t have to include it all in the main advertisement. And I think that this is an issue on which a lot of health advocates are aligning, because what they see is that pharmaceutical advertising does drive prescriptions. There are several studies suggesting that, in fact, the more you advertise a medication, the more likely a patient is to go to their physician and request it.
HLT: What does the administrative order purport to do?
Shachar: What we see with Robert F. Kennedy Jr. and the Make America Healthy Again movement is concern with the number of prescriptions Americans are receiving. It’s no secret that this camp has a strong distrust of the pharmaceutical industry in general, with reports coming out of RFK’s HHS pushing to solve some chronic illness and conditions with non-pharmaceutical interventions. He is promoting healthy eating and exercise to help manage some conditions that are currently being managed with medications.
This executive order is consistent with that messaging and RFK’s leadership on these issues. It is an executive order directing the FDA to close the loophole I mentioned, which would once again require advertisers to list all side effects. It essentially says that we need more transparent drug advertisements, if they’re going to be advertised at all. It also directs the FDA to be really aggressive with a crackdown on deceptive ads.
HLT: What could that look like in practice? Does that mean we’ll be seeing longer drug ads — or could they disappear from our televisions and social media feeds entirely?
Shachar: Well, RFK has been on the record as saying he would be happy to ban drug advertisements entirely, but I think that it is pretty clear that the FDA doesn’t have explicit permission to do so, nor would that necessarily be permissible for First Amendment and commercial speech reasons.
I feel like what this will do is make it more difficult to advertise. When you view pre-1997 commercials, they’re funny to modern viewers, because they last several minutes. People thought that was kind of strange even in 1993, when we had longer attention spans. I think having minutes-long ads today would be a nonstarter. This approach will likely cut down on the amount of ads without straightforwardly banning them.
HLT: You mentioned that the pharma companies will likely invoke First Amendment and commercial speech protections if they choose to challenge this executive order. What has the Supreme Court said on those issues that could be relevant here?
Shachar: For many years, commercial speech was thought to be out in the cold when it came to First Amendment protections, but then the Supreme Court really shifted, starting in the 1970s with Bigelow v. Virginia. That is a case in which somebody published information about how to access legal abortions in New York in a Virginia newspaper, and the Supreme Court said, “Yes, this is commercial speech, but it’s also a matter of interest, so it’s covered by the First Amendment.”
Then you start to get a series of cases where the Supreme Court is trying to articulate how the First Amendment protects commercial speech. Here, the classic case is Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, which gives us a four-part test to test the constitutionality of restrictions on commercial speech.
HLT: Could you explain what that four-step test is, and how a court might apply it to the executive order?
Shachar: The first step is whether the speech is lawful activity and not misleading. And if the answer is yes, then it is protected under the First Amendment. Then, you look to see if the government has a substantial interest in regulating the speech, and whether the regulation directly advances the government interest, and that it’s narrowly tailored enough to serve that interest.
In the situation we’re discussing, the information is certainly lawful, so the question is, what is the government’s interest in regulating it? Here, we could go in a lot of different directions. We might want to protect against the over-prescribing of low-value medications, or prevent excessive medical spending, especially with respect to Medicare, Medicaid, and Veterans Affairs. As to whether this restriction is directly enough related and narrowly tailored — meaning, is there any better way to get there — I think that’s a bit unclear.
The tricky thing about pharmaceuticals is there are actually three parties involved: the pharmaceutical company, which offers the medication, the patient, and the prescribing physician. It gets complicated because a pharmaceutical company might argue that all it’s doing is encouraging patients to have a conversation with a physician about whether a medication is appropriate for them, and it’s the physician who really should be making that prescribing decision. And then it gets even more complicated, of course, because most of us have insurers involved who are determining what we can access.
I think it will be interesting to watch these First Amendment challenges play out, because when it comes to commercial speech, pharmaceuticals are just a little bit more complex than a lot of other categories of commercial speech.
HLT: In your view, what impact could this executive order have, in the shorter and longer term?
Shachar: I think that this is an area where [President] Trump and RFK are aligned. A few weeks ago, there was some daylight between Trump and RFK, with Trump publicly coming out and praising vaccines and RFK indicating a lot of skepticism about vaccines. So, it may be that this is a good area for collaboration, because a lot of people are pushing in the same direction. I think we will probably see movement here again. It’s keeping with MAHA priorities and a concern about over-medicalization of our nation’s health. But I think we will also likely see challenges from the pharmaceutical industry, especially on First Amendment grounds.
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