TRANSKRIPTIO 🔗
Greg Levine: Hello, I'm Greg Levine, a partner in the life sciences regulatory and compliance practice group at Ropes & Gray. Welcome to Non-binding Guidance, a podcast series from Ropes & Gray focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
I'm here today with my fellow life sciences regulatory and compliance partners Kellie Combs, who chairs our practice group, and Josh Oyster. On today's podcast we will be discussing the Trump administration's recent announcements related to direct-to-consumer prescription drug advertising and what that means for the pharmaceutical industry.
These actions have received widespread media coverage and are the most important developments that have happened in the DTC drug advertising area in decades. We are recording this podcast late in the afternoon on September 26th, 2025. Let's jump in. Why don't we start by talking about the coordinated actions that HHS and FDA took, as well as the associated presidential memorandum. Kellie, could you give us an overview?
Kellie Combs: Sure. Thanks, Greg, and hello, everyone. On September 9th of this year, FDA and HHS announced what they are calling a “crackdown” on DTC prescription drug advertising. And these were highly coordinated announcements that followed a presidential memorandum from President Trump, and that also reflect the influence of HHS Secretary Robert F. Kennedy, Jr. and others in the Make America Healthy Again, or MAHA, movement.
On the same day that the crackdown was announced, the MAHA report was issued. In all of these publications that were issued on September 9th, we see references to what the current administration believes are negative effects of DTC promotion. Among other things, the administration complains that DTC promotion results in increased health care costs, results in over-prescribing and over-medicalization, and just generally the administration has expressed a lot of concern about consumers being misled by pharmaceutical advertisements.
Now, all of the announcements related to this crackdown apply on their face to DTC content. There are specific call-outs for TV and broadcast ads, as well as digital and social media channels. At the outset, FDA and HHS have announced three key actions that we'll discuss in more detail today.
The first is aggressive enforcement of promotional violations. We've already seen numerous letters issued to companies for alleged violations of FDA's promotional requirements. FDA has also promised increased oversight of digital and social media advertising, and has committed to initiating a rulemaking to alter the framework for DTC broadcast ads to ensure that more safety and risk information is provided to consumers.
Greg Levine: Thanks, Kellie, for that overview. Okay, let's dive into those different elements, and maybe we'll start with the last one on this proposed rulemaking because, Josh, the administration has characterized this rulemaking as intended to address a “loophole” in the law that FDA created in 1997. Can you give a little explanation of what we think of that? And perhaps we can point people to our client alert for more detailed discussion.
Joshua Oyster: Yeah, thanks, Greg. FDA focuses on this development in 1997, where FDA allegedly created a loophole that has allowed pharmaceutical companies to hide or withhold safety information when advertising their products. And what FDA is really referring to is the concept in a DTC broadcast ad that an advertiser can provide what's called the “major statement” of risks and accompany that with “adequate provision” for enabling consumers to get access to the drug's complete labeling as an alternative to providing a more detailed “brief summary” of all of a drug's risks.
Although the government frames this concept as having been created in 1997, its history is actually much more extensive than that. The concept of a broadcast ad disclosing the major side effects and contraindications of a drug and making adequate provision for dissemination of the approved labeling—that concept has been in the regulations that FDA has all the way back to 1969.
That was not a development that occurred in 1997. What happened in 1997 was FDA's issuance of a draft guidance that described an approach for how companies could fulfill the adequate provision requirement in DTC broadcast ads because there had been a lot of uncertainty among those in industry about how best to do that in a TV ad or another form of broadcast advertising. What FDA emphasized in the late 1990s when they issued this draft guidance and when they issued the final guidance is they didn't perceive that as a loosening of the restrictions on broadcast advertisements. They just viewed that as providing clarification to make those ads more feasible.
Fast forward to now, HHS is suggesting there is some significant legal change that occurred in 1997 that enabled this widespread proliferation of DTC TV ads. There wasn't actually a change in the underlying legal framework other than the issuance of this clarifying guidance. Now HHS is saying that FDA is going to initiate rulemaking to close the loophole. We don't know exactly what that rule making will look like. No proposed rule has been issued. If the administration does proceed with a proposed rule, they will likely face significant pushback from companies in industry that will undoubtedly raise legal arguments on a number of grounds, including potentially constitutional grounds, statutory grounds, and also administrative law grounds (for example, concerns under the Administrative Procedure Act). There are a whole plethora of issues that would be associated with FDA attempting reform to eliminate or “close” the adequate provision loophole that the administration perceives.
Greg Levine: Before that guidance in '97—I remember this quite well—companies did not generally advertise prescription drugs on TV because they did
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not see any way that they could comply with both major statement and adequate provision. That was the whole point of doing this guidance. There would be companies that would do more, like, infomercials that would take 30 minutes so that they could use the last five minutes of their time to just scroll the full package insert on the screen. But it really wasn't a practical way to do direct-to-consumer broadcast television advertising. So it seems like a consequence of what the agency is talking about would be to take us back to pre-'97. Do you believe that that's their intent?
Joshua Oyster: Yes, that certainly appears to be the objective that the administration has here. One of the announcements talks about FDA engaging in rulemaking to, “return to the pre-1997 status quo and to require full safety information in broadcast prescription drug ads.” So it seems like the outcome of any rulemaking would be to take away the adequate provision option for broadcast ads. But again, it remains to be seen exactly how FDA might achieve that in any proposed rule.
Greg Levine: But certainly that, I think, could raise some of the legal questions that you're raising as to whether what they're doing here would constitute effectively a ban in practice, right, on prescription drug advertising and DTC. So I would think that would be an important point there.
And for those who are interested, we have a client alert. It's titled, "The administration targets direct-to-consumer prescription drug advertising," available on our website where this is discussed in more detail. So thank you, Josh. Why don't we turn now to talk about the enforcement letters that FDA has issued already. Kellie, would you like to start that conversation?
Kellie Combs: Sure, thanks, Greg. On the 9th, FDA started by sending a form letter to every single sponsor of an approved drug or biologic, warning them that the agency was no longer asleep at the wheel. These were totally generic letters that didn't call out specific products or promotional material, but really, I think just intended to put sponsors on notice.
FDA subsequently has sent more than 100 cease and desist letters to companies that target specific advertisements. And of the batch that we've seen so far, 59 of those letters have gone to traditional biopharma companies while the rest have gone to telehealth companies and compounders. Most of the letters that we've seen to date have targeted DTC TV commercials, but many address other forms of DTC promotion, including videos that are available online, sponsored links, earned media, patient websites, and print materials.
The most recent tranche of letters that was posted on September 25th, though, all relate to HCP directed promotion, so I think it's important to keep in mind that even though HHS and FDA are so far framing this as a crackdown on DTC, there are much broader implications for all promotional content, regardless of the audience.
With the letters that have been issued to
date, we're certainly seeing some common themes in those letters. Many of them relate to some sort of overstatement of clinical benefit, where FDA is taking the position that the underlying study does not support the promotional representation that's included in the piece. There are also a number of letters that relate to implied quality of life claims based on actor portrayals where essentially FDA has taken the position that a patient might look too carefree or too happy, and that company does not have the clinical data to support those quality of life impacts.
Not surprisingly, there is a very significant focus in the letters on misleading presentation of risk information, and this comes in a couple of different forms. A lot of the letters that we've seen so far relate to communication of the major statement during a DTC broadcast ad. And FDA has taken the position and is complaining in those letters that there are too many attention-grabbing visuals or compelling scene changes—basically too much going on in the commercial in a way that interferes with the major statement.
Similarly, many letters call out companies for failure to adequately disclose serious risks associated with the product or completely omitting risk information altogether. So there are a number of letters that relate to boxed warning products or letters where companies are being called out for not conveying the limitations of use, including in DTC materials like sponsored links.
And then finally, as we often see in FDA letters, the agency is commonly taking the position that whatever disclaimers may appear in a promotional piece or whatever context is provided, the disclaimer is not sufficient to overcome the misleading impression of the ad.
Greg Levine: And in addition to the letters that have gone to traditional pharmaceutical companies, there have been a number of letters, I think the majority of letters actually of the 100, that went to other kinds of entities like online pharmacies, telehealth providers, those engaged in compounding. Josh, can you comment on what those letters look like and the themes that we've seen in those letters?
Joshua Oyster: Yeah, absolutely. We're talking about the letters that went to compounding pharmacies, telehealth providers, and others engaged in compounding. A lot of that compounding investing GLP-1 medications but not exclusively GLP-1 medications. And these letters to compounders are alleging, generally, that the compounders or the telehealth providers advertising on websites are false or misleading because there are certain claims that the FDA is alleging imply that the compounded products have FDA approval when, in fact, of course, the compounded products do not have FDA approval.
This is noteworthy for a few reasons. There has been a lot of attention to the widespread proliferation over the last couple of years of compounded GLP-1 medications, and there was a question that many of us had around to what extent is FDA going to police and really enforce requirements with respect to the compounding of GLP-1 medications subsequent to the resolution of shortages of some of the approved branded GLP-1 medications.
It seems now FDA certainly doesn't seem to be hesitating in issuing letters to compounders related to false or misleading advertising of compounded GLP-1 drugs or other drugs. One specific example that had been closely watched by industry and many others was whether FDA was going to pursue any action with respect to Hims and Hers. Hims and Hers had gotten some congressional scrutiny following a Super Bowl ad earlier this year regarding their compounded products. They actually ended up receiving two warning letters related to their compounded drug advertising, although, interestingly, neither of those warning letters actually cited the Super Bowl ad. They only cited the website.
Greg Levine: Josh, why do you think that would be the case? Why would they target a more recent ad but not that Super Bowl ad which they had emphasized so strongly?
Joshua Oyster: It really is curious and difficult to understand, particularly when FDA Commissioner Makary recently published an op-ed in the Journal of the American Medical Association discussing the FDA's various actions related to DTC advertising. And in that op-ed he specifically called out the allegedly misleading Super Bowl ad by Hims and Hers. Yet the warning letters that FDA sent didn't cite that ad. So there's a little bit of a disconnect there that you can't quite square.
Greg Levine: One thing about these letters, they seem in some respects to be a little bit different from typical letters that we've seen, at least in terms of form. They don't have some of the statutory citations. There are people who have speculated that perhaps there's AI involved. Just curious, either one of you, Kellie or Josh, your perspective on that.
Kellie Combs: I think it's safe to say that many of the letters that we have seen from FDA have been highly atypical as compared to standard correspondence from OPDP or from APLB. There are variety of reasons to think that these are not standard letters. The one that really sticks out to me is that in many cases the allegations are extremely high-level. A number of letters that have been issued are a page and a half long or are two pages long and contain virtually no information about the product background, the prescribing information, and, importantly, don't contain any citations to statutory or regulatory provisions that companies have allegedly violated beyond just a pretty generic reference to the Food, Drug, and Cosmetic Act. That's really different from what we've traditionally seen from FDA in this area where FDA often goes point by point and claim by claim to explain to companies why FDA believes that the promotion is false or misleading or otherwise violates the law.
Some other differences just to point out—as a general matter, although this is not true in every case, the new letters
that we're seeing are signed by the director of CDER or the director of CBER as opposed to OPDP staff or APLB staff. And at a high level in many cases we just don't see the type of rigor or nuance that we're used to seeing with traditional FDA letters based on promotional violations.
Greg Levine: And perhaps not surprising, right, because the numbers of people working in the OPDP office, for example, have been dramatically reduced. So if FDA's promising to increase enforcement and to not be asleep at the wheel, perhaps they need to rely on technology to try to help with that, right?
Kellie Combs: That's absolutely the case, right? And FDA I think has been transparent about this, as Commissioner Makary has said multiple times that they will be using AI and other tools to proactively surveil and enforce in the promotional arena. Your point about OPDP personnel I think is really well taken.
One question that many of our clients are raising is what do we think engagement with FDA is going to be like during this process? How many people might companies be able to work with to the extent they need to discuss remediation plans with FDA or to the extent they have other questions about promotional materials going forward? And these remain really big, open questions from our perspective.
Greg Levine: Right, so FDA has said that they intend to ramp up enforcement even further beyond this first release of approximately 100 letters. What do we think is coming next?
Joshua Oyster: Well, FDA telegraphed that if industry practices do not meaningfully change (although it's not entirely clear what that means), FDA will continue enforcement activity and will return to the 1990s paradigm of issuing hundreds of enforcement letters each year. Now, if FDA's enforcement approach is supported by AI, there's really no bandwidth limitation then on the number of letters that FDA can issue. Historically, the quantity of FDA's enforcement at some level was limited by the number of people that they have.
However, if FDA is going to be relying on AI tools to support enforcement and is comfortable issuing enforcement letters that are higher level in detail than maybe letters have been in the past, then the ability of FDA to issue a significant number of letters each year is there. FDA will have that capability and I think it's something that companies have to be concerned about. And one thing that we didn't talk about earlier is even just the way the FDA separated out these letters when it was issuing them where different ads by the same company or even the same product may have been the subject of multiple letters.
Perhaps you have a situation where in the future a company could receive multiple letters related to the same product and have to deal with responding to those letters at the same time. That can be a significant burden, obviously both for the process of responding to FDA and engaging with FDA relating to those letters, but of course then also remediating any non-compliant advertising. I think companies certainly need to be very aware of the shift in the enforcement posture and taking that into account as they think about compliance risk that they're willing to consider and take on with future advertising.
Kellie Combs: It's also worth noting that HHS and FDA have made clear that they're going to take a harder line on enforcement. We're not just going to see more letters but we're also going to see FDA potentially taking different positions. Because, in the announcement that came out a couple of weeks ago, the agency said that it was going to be taking a more expansive interpretation of its own authority and that was in contrast to the “overly cautious approach taken by previous administrations.” So I think it's possible we'll see changes in opinion coming from FDA. A lot more cases on the edge that would potentially impact materials that had been rigorously evaluated by promotional review committees at companies and that nevertheless get called out by FDA.
Greg Levine: Yeah, very interesting. I mean, we're speculating a little bit on the use of AI, whether it's being used. It certainly seems to raise the prospect of a lot more letters coming. It also raises questions about the quality of those letters, how thorough they will be, and how accurate they will be I suppose as well. So that would be interesting to watch going forward. Okay, let's turn now to talk as well about the aspect of the announcements that focused on digital and social media. Kellie, you want to start us off with that?
Kellie Combs: Sure. So as part of these coordinated announcements we saw on the 9th, FDA's pledged to close “digital loopholes in its oversight of DTC drug advertising.” And among other things, the agency contends that there's been kind of this increasing reliance on social media and on digital forms of promotion, and that there's been a blurring of the lines and that sometimes consumers may not necessarily understand when internet or social media content is pharmaceutical advertising as opposed to organic or user-generated content or advertorial content, and so on.
The focus areas that FDA has called out so far include things like influencer content and sponsored posts, algorithm-driven targeting and dark ads, as well as AI-generated content like chatbot interactions. And I think it really remains to be seen what FDA does in this arena. Keep in mind that there are no FDA regulations that expressly relate to digital or social media promotion. It's also important to remember that FDA's statutory authority to regulate these sort of communications are somewhat limited, so the agency only has authority over content that is appropriately considered labeling and advertising, and a lot of the stuff we see online and in social media may not fit within that category, either because it's unbranded or it might be a medical communication.
Similarly, the agency only has current statutory authority over material that's put out
by a company or someone acting on a company's behalf, so a lot of the independent content that you're seeing from social media influencers FDA does not have jurisdiction to regulate. We don't know what FDA's going to do in this area but I think as an initial matter we can expect to see more action on space-limited platforms or with video format where there's some sort of limitations and it might be more challenging for companies to convey safety and risk information.
Greg Levine: Lastly for today, why don't we talk about how companies should be thinking about the risks that are associated with direct-to-consumer advertising in this environment, in this landscape? DTC ads are permitted by law. FDA's guidance still exists as it has—its guidance is still there today. Yet the government is taking this aggressive enforcement posture and the messaging around DTC advertising is highly negative, very hostile. What do you think about if you're a company in this space?
Kellie Combs: Well, I think what you first acknowledged, Greg, is incredibly important to remember, which is neither the legal or regulatory requirements for DTC advertising have yet changed. All that said, I think it's very important to be mindful of enforcement risk and to really implement a risk-based approach when you're thinking about your DTC marketing materials.
For example, do an inventory so that you understand all the DTC and other collateral that may be out there across the company and for your brand. And think about ways to triage any review, reevaluation, or remediation of those materials to make sure that they're consistent with legal and regulatory requirements, but also mindful of what might be changing regulatory expectations.
For example, focusing on high-profile content--you know, your key DTC materials. Thinking about content that would have high exposure through social media influencers, through other campaigns, things that are going to be reaching a really large audience. As I mentioned earlier, a focus on video format or other space and time-limited formats I think is a good place to start because we know that FDA cares deeply about the communication of safety and risk information, and those formats just make it harder to present all the information.
When we talk about a risk-based approach, what do we mean here? We understand that even within a company you might not necessarily be able to implement a one-size-fits-all approach across your brand. So you need to be thinking about the company's risk tolerance. Would the company be willing to get a warning or untitled letter from FDA and how would the company defend against an action like that? Think about the extent to which FDA's provided prior feedback, whether it's on the clinical data supporting a claim, or perhaps you've submitted materials to FDA in the past for advisory comment. Maybe you've received an untitled letter in the past and that would certainly amp up your risk profile. And it's also important to consider this most recent round of letters, where we know that FDA is very focused on things like communication of safety and risk information, quality of life claims, and other materials that FDA would allege to be false of misleading.
Joshua Oyster: It's also worth taking into consideration the reality of the competitive landscape of your products, and the potential consequences of an overly conservative approach to advertising and promotion. If you don't make certain claims but your competitors do, you know, how does that affect your business? That's obviously a factor that naturally gets considered as part of these decisions.
I think we'll certainly see, even in the short-term, some targeted changes to DTC campaigns. You know, we're working with a number of companies on these issues, including companies who both have and have not received cease and desist letters from FDA. And they are all being very thoughtful about next steps, so really thinking about the areas of promotion including DTC where, for example, they're using social media influencers, where they're using patient ambassadors, where they've got partnerships where the company may not have complete control over those communications, and yet in this new environment they still present a great degree of risk for the company.
I think it's very important to keep in mind at this stage and as always, to the extent a company becomes aware of any material that's already been disseminated that may be false or misleading or inconsistent with FDA expectations, it's important to promptly remediate that content either by pulling it down from the web or from making some targeted revisions. This is something that I think lots of companies will need to think very carefully about going forward to ensure that their monitoring program is, you know, completely appropriate and sufficient to catch all of these issues and that you're taking thoughtful risks going forward.
Greg Levine: Thank you both very much, and as I said at the outset, this is really one of those issues where there's a lot happening under this administration, but this changes a nearly 30-year policy of the FDA that they are turning around essentially 180 degrees. So, this is a really important development and something we're going to be following closely for some time.
That's all the time we have for today. Thank you very much to everyone for tuning into this episode of Non-binding Guidance.
For more information about our practice or other topics of interest to life sciences companies, please visit our FDA regulatory and life science practice pages at https://www.ropesgray.com/. you can also subscribe to Non-binding Guidance and other RopesTalk podcasts at Ropes & Gray's podcast newsroom on our website or by searching for Ropes & Gray podcasts in iTunes or Spotify. Thank you again for listening.