Pharmacists’ Role in Translating FDA’s New Direct-to-Consumer Advertising Rules

In this Pharmacy Times interview, Edgar Asebey, Esq, discusses the FDA’s push to tighten standards around direct-to-consumer pharmaceutical advertising and the critical role pharmacists can play as communicators during this transition. He explains that while pharmaceutical companies have generally complied with existing rules, enforcement has been inconsistent, particularly around requirements for consumer-friendly language, dual audio and text, appropriate text visibility, and the absence of distracting elements. As new rules and enforcement efforts emerge, Asebey emphasizes that pharmacists are uniquely positioned to help patients interpret risks and benefits more clearly, moving beyond advertising-driven impressions toward evidence-based understanding that supports informed decision-making.

Pharmacy Times: Do you expect pharmaceutical manufacturers to push back legally against these tighter standards?

Edgar Asebey, Esq.: Yes, I think what I want to say about the tighter standards is that, just as an aside—but I think it's an important aside—the pharmaceutical companies are regulated by the FDA, and they always try to stay on the right side of the FDA. They try to comply and play by the rules.

Right now, this is all being characterized as a loophole that has been around and that they are going to close. That is a statement from the FDA. Pharmaceutical companies have done what the FDA permits them to do. Now, there has been, in my opinion, lax enforcement of the five criteria that became part of the final rule.

Those five criteria are:

1. The language has to be consumer-friendly, meaning it cannot be jargon. It has to be understandable. This is the language that talks about both the benefits and the risks associated with any drug.
2. There has to be understandable audio in the advertisement.
3. There has to be dual modality—both audio and text concurrently.
4. There must be appropriate text presentation, meaning it has to be sufficiently visible on the screen. This is where we start sliding a little bit. How many people actually read the fine print in the last five seconds in which it appears in an advertisement? That does not seem adequate, because the rule says that you have to give as much prominence to the adverse effects as to the benefits. The adequate provision rule reduced that in 1997, and I think that's what is being corrected now in this enforcement action.
5. No distracting elements. This is what will be course-corrected under the new rulemaking.

The requirement in the final 2023 rule for direct-to-consumer advertising of pharmaceuticals is that during the presentation of the major statement—the major statement of adverse effects—the advertisement must not include any audio or visual elements that interfere with the consumer's ability to comprehend that major statement. That major statement is the statement of risks.

If we look at advertisements, especially on TV or in social media, they show a very rosy and positive vibe. They don’t show the adverse events or the risks in equal balance. I think that is the course correction the FDA is trying to make, because they believe that patients and consumers are seeing too rosy a picture that is not balanced. The distracting elements are all the positive vibes and impressions you get from advertising, which all advertisers want. But this is a regulated industry, and the FDA wants advertisers to be responsible so that a patient or consumer walks away with a real impression of both the benefits and the risks. I think the risks have not been given enough prominence, even under the existing rules.

So the FDA is going to undertake new rulemaking, but even under the existing rules, I think enforcement has been a challenge for the FDA. Some course correction will take place in that respect.

To your question, I think pharmaceutical companies will exert some pushback because they have attempted to be compliant. I believe some will push back and say, “We are compliant with this.” But also, pharmaceutical companies—and anyone regulated by the FDA—want to have a good relationship with the agency. So I believe they are going to take these warning letters seriously. They will make the necessary adjustments, and when the new rules come out, they will seek to be compliant with those rules as well.

Right now, we are not seeing penalties issued. This is the warning letter stage, or the untitled letter stage, which gives companies an opportunity to come into compliance. I think most companies will take that route.

Pharmacy Times: Pharmacists are often on the front lines, fielding patient questions sparked by drug ads. How might these new rules change the kinds of conversations pharmacists will have with their patients?

Asebey: Pharmacists are going to be a key communicator in this transition, where the FDA seeks to pull back a little more toward the old days when consumers didn’t go to their doctors saying, “Hey, I saw this on TV. I think it’s good for me.” This is advertising-driven. As the FDA commissioner put it in his recent JAMA article, it’s “market-induced patient demand versus evidence-based prescribing protocols.” And I think there’s some truth to that. Advertising does influence us, and sometimes it influences us in ways that are not as informed as what a doctor or pharmacist would provide.

Now, when there are questions regarding certain drugs, I think pharmacists can play a key role in translating all that fine print that may not appear in advertisements but is important for patients to understand. It is, in some ways, like the old days when pharmacists counseled patients on the benefits and risks of certain drugs. Even though that is primarily the role of the physician, pharmacists are well suited to help communicate this information.

For example, a patient might say, “Yes, I want this GLP-1,” but the pharmacist can ask: Do you know the long-term effects? Is this something you’ve considered? Have you even heard about this risk? Pharmacists are in a learned intermediary position where they can help patients understand, in a more balanced way, the risks and benefits of a drug that may be very efficacious. That gives patients the opportunity to make decisions with better information.

I think pharmacists can step up to this challenge right now, when there is likely to be consumer and patient confusion. They are going to hear things that are not as rosy as before, or information that is different from the advertisements. That is where pharmacists have an important role in this moment, as the FDA pursues new rulemaking and enforcement initiatives to change the way direct-to-consumer advertising impacts patients.