On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray's life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA's revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA's prior draft guidance, potential challenges in implementing the FDA's recommendations, and how the new guidance fits within the FDA's overall framework for medical product manufacturer communications.
Transcript:
Kellie Combs: Hello, and 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 Kellie Combs—I'm a partner and chair of our global life sciences regulatory and compliance group and co-chair of the firm's cross-practice digital health initiative. I'm here today with Josh Oyster, another partner in our life sciences regulatory and compliance group. We've worked together over the years on a number of matters involving FDA's regulation of manufacturer communications. Relatedly, today, we'll be discussing a revised draft FDA guidance document entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers."
Josh, let's start with the basics: what's covered in the new guidance and why is FDA addressing misinformation?
Josh Oyster: Sure—thanks, Kellie. The new revised draft guidance describes an enforcement policy for how companies can issue certain kinds of internet-based communications to address internet-based misinformation which comes from an independent third party that is about or related to the company's approved or cleared medical products. FDA calls these types of communications "tailored responsive communications," and the guidance goes into the considerations that FDA expects these communications should adhere to in terms of being truthful and accurate, being scientifically sound, being directly relevant and responsive to the identified misinformation, and a series of other considerations that FDA describes in more detail in the guidance. The guidance also discusses—and in many respects tries to summarize—other avenues by which companies could communicate to address misinformation in a more general sense. FDA calls these "general medical product communications," and these are the typical promotional pathways and other pathways that FDA has described in prior guidance documents.
With respect to misinformation, FDA has long considered medical misinformation to be a significant problem and has observed that many false statements and conclusions shared online and the way that social media platforms are structured have meant that false, inaccurate, or otherwise misleading information about medical products can spread rapidly to a broad audience. Misinformation and the need to combat it became a significant focus during the COVID-19 pandemic as there was widespread misinformation about vaccines, COVID-19 tests, and other related products. In 2023, the Reagan-Udall Foundation completed a report on strategies for improving the public understanding of FDA-regulated products and gave FDA a number of recommendations, but there was little role in that report contemplated for medical product manufacturers themselves to combat the spread of misinformation. The new revised guidance is welcome in some respects because it recognizes the value that medical product manufacturers can have in combating misinformation. And indeed, FDA's press release announcing the revised guidance talked about how this is supposed to "further empower" medical products companies to combat misinformation about their products.
Kellie Combs: Thanks, Josh. You specifically mentioned efforts to combat misinformation during the pandemic. There was a time when many new products were coming to market through the Emergency Use Authorization (EUA) pathway. How does the revised draft guidance address these sorts of EUA products?
Josh Oyster: The short answer is that it doesn't—it actually excludes them. In a Federal Register notice accompanying the release of the draft guidance, FDA says that misinformation about EUA products is a public health concern and goes on to say that FDA's continuing to evaluate the unique considerations that apply to communications about these products, and therefore, the revised guidance doesn't address EUA products at all. So, in some sense, it's a little bit of a cop-out and disappointing that part of the impetus in recent years for addressing misinformation has specifically involved these kinds of emergency use products, and here, FDA declines to apply this new guidance to that very category of products.
I'm going to ask you a question, Kellie. This guidance is styled as an update to a 2014 draft guidance, and FDA says the new guidance replaces and supersedes that one—that was the Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices draft guidance. In the 10 years since the release of that one, what are the key changes here and what's evolved in FDA's thinking?
Kellie Combs: There are really a handful of changes that are worth talking about today. The first is the change in how independent content is described in the guidance. Under the guidance or the "enforcement policy," firms are only subject to the enforcement policy if they're addressing misinformation from an independent third party. In 2014, FDA advanced a really broad view of when firms were responsible for misinformation, meaning when a third-party communication was not truly independent from the firm. FDA stressed that a communication was not independent from the firm if the firm "owned, controlled, created or influenced, or affirmatively adopted or endorsed" the communication. That formulation, which is very broad and pretty squishy, was a key concern that was addressed in many sets of industry comments that were submitted to FDA about that draft guidance back in 2014. The new formulation in the updated guidance is just tied to whether a communication is by or on behalf of the firm. This more closely tracks the Food, Drug, and Cosmetic Act and implementing regulations and should be more straightforward for companies to think about.
In addition to that change, in terms of how independent content is defined, this new guidance document expressly contemplates that communications can be promotional, and it also contemplates that off-label information can be shared to address misinformation. Back in the 2014 version, the recommendations in the guidance provided that any efforts to address misinformation to fall under the guidance should be non-promotional in tone, nature, and presentation, and also that the information should be consistent with label. Here, at least, FDA acknowledges that off-label information can be shared when the misinformation relates to whether a product should be used for an unapproved use. FDA also goes on in the guidance to talk about various recommendations for content and presentation related to that communication to address the misinformation. FDA says, for example, that tailored responsive communications should be truthful and not misleading, scientifically sound, directly related and responsive to the misinformation, and contain various disclosures that are outlined in the guidance.
Josh Oyster: Some of the points you just covered about promotional versus non-promotional could segue into talking about how exactly FDA frames the enforcement policy in the revised guidance. FDA says that if a firm chooses to share a tailored responsive communication—again, these are voluntarily things—FDA "does not intend to enforce" applicable requirements "if any" related to promotional labeling and advertising or post-marketing submission of promotional communications on Form 2253. It's an interesting phrasing there—the "if any"—because it leaves open the door. Are these really labeling and advertising in FDA's mind and, if so, under what circumstances? Are only certain categories of tailored responsive communications labeling and advertising? It leaves a certain amount of ambiguity that perhaps will be unsatisfying to industry.
Then, similarly, when talking about tailored responsive communications that address misinformation that suggests that a firm's product might be used for an off-label use, FDA says they "don't intend to use such communication standing alone as evidence of a new intended use." That's phrasing that we've seen previously in the last couple of years, including in the intended use final rule from 2021 and the SIUU guidance that came out last year and that we've discussed on a prior podcast. That "standing alone" language leaves open the idea that if there's other evidence of a new intended use then FDA might consider this seemingly otherwise safe harbored communication as part of that broader set of evidence. In some ways, it then calls into question the entire value of the safe harbor. It'll be interesting to see how industry reacts to that and is something to continue to monitor as FDA's policies evolve in this area. Their language is getting increasingly more precise and caveated in a lot of respects, where those caveats are really, I think, intended to try and stake claim and preserve as much as possible the FDA's authority.
Switching gears a little bit, Kellie, what are some of the key challenges that companies might face in trying to implement the FDA's recommendations here? The first one that jumps out to me is dealing with the way the guidance talks about opinions and value statements.
Kellie Combs: Sure—thanks, Josh. The guidance or the so-called "enforcement policy" covers certain efforts to address misinformation. Misinformation is defined in the guidance as "implicit or explicit false, inaccurate, or misleading representations of fact about or related to a firm's approved or cleared medical products." But FDA goes on to say that misinformation does not include opinions or values statements, and it also doesn't include representations about an individual patient's experience. Now, you could see how there might be very close calls that manufacturers may have to make when they see information or misinformation that's proliferating online. For example, close calls related to when a patient is talking about her personal experience or when it becomes a misrepresentation of fact—she's saying that a product worked or didn't work. Obviously, if it's in the context of her own experience it seems like it would be outside the guidance, but depending on the language, I think there could be some ambiguity there. Now, of course, that's not to say that companies cannot address any sort of information online, even if it's not specifically covered by the guidance, but they wouldn't have the benefit of that enforcement policy if so.
There are also some nuances to consider with respect to off-label use, and this is a situation where the examples in the guidance are not very helpful—they're very straightforward. FDA clearly says that the enforcement policy would cover situations where the misinformation suggests that a product should be used for an unapproved use. But the guidance is silent on whether or how companies could address misinformation suggesting that a product should not be used for an unapproved use. For example, consider a scenario where an influencer is posting online about how an off-label use poses serious safety concerns when there's no information to suggest that serious safety concerns are associated with the off-label use. The guidance doesn't provide any detail on whether or how a firm should be acting under those circumstances.
I think the last thing—just as a practical matter that's worth considering—is that the Agency gives its perspective on how companies should be prioritizing misinformation and how they might be addressing it online. This is all, of course, with the very important understanding that companies are not responsible for correcting or addressing third-party misinformation. But FDA says that if you're going to address misinformation, here are some things to keep in mind, including how popular or how much exposure the false information is getting online. There might be situations where misinformation is just proliferating so quickly—it becomes so big; a post becomes viral—where it's just simply impossible for the company to keep up with the misinformation and to communicate quickly and effectively in order to nip it in the bud. That's something else that unfortunately is not covered in the guidance.
Josh Oyster: Thanks, Kellie. More generally, how does this guidance, which is addressing a particular type of manufacturer communication, fit into the Agency's overall framework for medical product manufacturer communications?
Kellie Combs: I think in many ways, the Agency's approach to policymaking is pretty consistent with what we've seen for quite some time. The Agency has this practice of picking these pretty discrete, one-off topics focused on a particular type of communication and then issuing a guidance document around that specific type of communication. By regulating or issuing these guidance documents in a piecemeal fashion, what we don't see from the Agency are broad, cohesive principles that manufacturers may be able to apply to any scenario that comes up. For example, we don't have cohesive principles for non-promotional communications. Whether it's related to misinformation or otherwise, we get these guidance documents that oftentimes tend to languish as technology advances or there may be other reasons for the guidance document to go out of date.
Joshua Oyster: This is another guidance that I find very interesting because of what FDA doesn't mention, and that's the concept of "scientific exchange." FDA, by regulation on the drug side at least, has long recognized that FDA does not restrict the full exchange of scientific information concerning a drug, including dissemination of scientific findings in scientific or lay media. But FDA has never established a clear, understandable, all-encompassing definition of what "scientific exchange" is and isn't and of how you distinguish scientific exchange from promotion. Notably, 37 years ago in a Federal Register preamble, FDA said that FDA's understanding of commercial promotion does not place limits on the free exchange of scientific information (e.g., publishing results of scientific studies, letters to the editor in defense of public challenges, and investigator conferences). Now, that "letters to the editor in defense of public challenges" item is interesting when you think of it in the context today of addressing misinformation. If FDA thought in 1987 that a letter to the editor defending a scientific challenge could be, and was, scientific exchange (which FDA wouldn't regulate), why wouldn't a tailored responsive communication on the internet—in some respects, the modern equivalent of such a letter to the editor—to address misinformation be considered scientific exchange today? It's a question that FDA doesn't grapple with in the guidance because they never bring up scientific exchange at all and they ignore its potential relevance to policymaking in this area. It leaves open more questions than I think industry likes in that regard.
Kellie Combs: Thanks, Josh. That's a great perspective on scientific exchange and certainly agree that it would be helpful if we had some cohesive principles to guide our communications rather than waiting for FDA to issue these guidance documents on a one-off basis. We certainly talked through a lot of interesting issues with respect to the guidance today, and, Josh, you've given me a lot of food for thought. Comments to the guidance are due on September 9. To the extent anyone listening has questions or would like to discuss the guidance in more detail, we'd be happy to have a conversation with you. For now, though, I think we're out of time.
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