FDA Draft Guidance for Misinformation – Part 2
In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (the "Draft Guidance"). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling of approved/cleared medical products ("firms") to respond to internet-based posts and comments in a manner consistent with existing product labeling and advertising laws.
While the Draft Guidance seeks to remove regulatory hurdles for firms seeking to take proactive steps to counter false, and potentially dangerous, claims about their products over social media and other internet platforms, questions remain over whether it sufficiently equips firms to address the realities of the so-called "epidemic of misinformation." During an open comment period that officially ran from July 8, 2024 to September 9, 2024, several firms and industry stakeholders submitted letters to the FDA with criticisms, suggestions and requests for clarifications. These letters invoked variety of questions that remain unanswered. This article highlights some of the notable comment themes mentioned in the letters.
Industry Comments
The various letters submitted to the FDA point out potential gaps and issues with the Draft Guidance and offer suggestions for improvement. Some of the key themes are discussed below with links to representative comments.
- Timely Finalization
Some commenters asserted that timely finalization of the Draft Guidance would be essential to its efficacy. As noted in our prior post on this topic, the July 2024 Draft guidance replaces a prior draft originally issued but never finalized more than ten years ago. Accordingly, allowing it to remain in draft form for a similarly extended period of time, particularly where the Draft Guidance purports to set out “enforcement policy,” may undermine the predictability it seeks to foster. As one commentator suggests, finalizing the new Draft Guidance more promptly would provide stakeholders with a greater degree of certainty and additional assurance in the FDA’s position regarding how firms may legally respond to social media misinformation. See Comment from Pharmaceutical Research and Manufacturers of America (PhRMA), posted September 9, 2024.
- Enforcement Policy
Some commentators have additionally voiced concern around the Draft Guidance’s theme of "enforcement policy" and its suggestion that responses to social media misinformation would otherwise potentially violate existing advertising and labeling laws or constitute evidence of a new intended use of a product. The PhRMA comment, for example, suggests that a better approach could be for the FDA to declare affirmatively that responses to social media in accordance with the Draft Guideline are not advertising, promotional labeling, or evidence of intended use under sections 502(a), (f), and (n) of the FDCA and sections 201.100(c) and (d) of Title 21 of the Code of Federal Regulations. The Advanced Medical Technology Association (AdvaMed, comment posted September 9, 2024) similarly seeks a definitive clarification on copyright law and the reproduction/re-posting of content containing the misleading information as part of corrective efforts. In other words, a safe-harbor presumption of non-violation, rather than requested reliance on administrative agency enforcement discretion, would arguably go further in fostering firm engagement.
- Independent Third Parties
Commentators have also sought further clarification on the FDA’s use and discussion of the term “independent third party.” According to the Draft Guidance, a manufacturer does not have an obligation to respond to persons or entities that are not acting on behalf of that firm and are therefore “independent.” However, critical questions remain. For example, would the term “independent third party” exclude an entity with a past or present financial relationship with the firm, even if that relationship is unrelated to the offending post in question? See Comment from Generation Patient, posted September 9, 2024. Another commentator suggests that the Draft Guidance’s discussion of independent third parties should explicitly acknowledge that the term may include “newer categories of market entrants,” such as compounding pharmacies and telehealth providers (who themselves may be subject to FDA regulation) and that misinformation created by such commercial entities may also be appropriately addressed. See PhRMA Comment.
- Social Media Platforms
The inherent restrictions and dynamic nature of social media platforms themselves may also present logistical and practicality issues that expose gaps in the Draft Guidance. AdvaMed and others suggest that the current recommendations are too rigid and may not be practical for all platforms, such as those with character limits. Commentators have also expressed concern over a lack of clarification surrounding the level of discretion a firm has to triage sources of misinformation, measure criticality among social media platforms and posts, and ultimately choose to engage some communications over others. For example, if a firm responds to an original media post, but other platform users respond to either the original or subsequent sub-posts, is the firm then obligated to respond to all those posts as well? Relatedly, if a firm sets up a program to monitor social media about its product, can it later discontinue the program whenever it chooses, or is it then expected to continue to monitor and respond to related social media misinformation indefinitely? In sum, additional clarification is requested on the scope of firm discretion with respect to social media and confirmation that a single targeted, tailored, responsive communication does not then unintentionally create broader or ongoing responsibilities. See Comment from LiveWorld Inc., posted August 11, 2024.
- Artificial Intelligence
Artificial Intelligence (AI) is another recurring and sensitive topic among commentators. As AI adoption and use expands in 2024 and beyond, AI-generated content is expected to increase. Identifying which content is AI-generated, and verifying AI sources of information and misinformation, is becoming increasingly difficult, if not impossible. See PhRMA Comment. There is some shared concern over the potential for the AI impersonation of companies or individuals, such as through deepfake technology, which could have serious consequences for public trust, safety and company reputations. AI systems can also innocently confuse objective information, such as products that have the same name but different uses, or companies that have the same name but operate in different industries, thereby leading to the conflation of product usages, side effects, company reputations, and more. See AdvaMed Comment. Firms are requesting the FDA to acknowledge the unique difficulties AI technology presents and offer practical guidance for foreseeable circumstances.
- Overall Scope
Finally, commentators have suggested that the Draft Guidance enforcement policy is overly narrow and should be expanded. In particular, the Draft Guidance does not address misinformation regarding products with an emergency use authorization (“EUA”). See Comments from Medical Information Working Group (MIWG), posted September 8, 2024, and PhRMA. Commentators have noted the dangers inherent in rampant misinformation regarding vaccines prevalent during the height of the COVID crisis as an example. See Comment from Alliance for mRNA Medicines, posted September 5, 2024. The Draft Guidance also currently excludes responses to “opinions,” “value judgments,” or “representations of individual experience” unless they contain broader false or misleading statements. If a social media influencer posts an opinion that a certain product is highly dangerous and no one should use it, commentators argue that a firm should be permitted to issue a tailored response citing evidence of the vaccine’s safety and efficacy. See PhRMA Comment. The Draft Guidance, as currently published, does not expressly provide for such activity.
Despite the criticisms and suggestions described above, it is worth noting that almost all the commentators have praised the FDA for updating and issuing the Draft Guidance, and have cited the benefits of enlisting firms to help counter misinformation regarding medical products. It is also noteworthy that the comments were largely constructive in nature, suggesting specific revisionary language for added clarity and industry certainty.
Duty to Monitor or Correct Misinformation
As some of the comments seem to suggest, there may be some uncertainty surrounding whether firms have an obligation to monitor and correct misinformation disseminated about their products, and whether the Draft Guidance could be viewed as creating or supporting any affirmative legal duty to do so. The Draft Guidance, however, is expressly directed to firms who “voluntarily address” product misinformation, and its guidelines are repeatedly couched in terms of choice. The closing paragraph of Section I. the Draft Guidance states that it “do[es] not establish legally enforceable responsibilities” and “should be viewed only as recommendations.” A footnote on one page further clarifies that “[b]ecause addressing misinformation is voluntary, firms are under no obligation to continue to monitor or address responses to the firm’s tailored responsive communication.” Thus, while the Draft Guidance provides a roadmap for firms to address misinformation in compliance with existing laws and regulations, it arguably does not attempt to impose, create, or highlight any legal or regulatory obligation on firms to actually do so. Nevertheless, it remains to be seen whether the Draft Guidance may be cited to impose such a duty on firms in the tort system. If any lawsuits are filed asserting such theories, they are certain to be closely monitored in the industry.
The Way Forward
As social media platforms continue to grow and expand in influence, misinformation about medical products similarly will proliferate at an unprecedented level. In the past, the FDA has attempted to educate the public about medical product misinformation by issuing public pronouncements and has introduced the “FDA Rumor Control web page,” but the FDA’s resources are increasingly limited. Through its recently updated Draft Guidance, the FDA is attempting to go a step further by enlisting firms to aid in countering false, and potentially dangerous, online posts and comments about medical devices and drugs. Firms are reportedly eager to join in this fight, as misinformation can result in serious injuries from misuse and nonuse of their products. It is unclear whether the FDA will incorporate any of the several suggestions for improvement into a final guidance document. Nevertheless, before choosing to engage with any misinformation, firms would be well advised to consult the Draft Guidance and to craft their response approaches carefully to minimize both regulatory and legal risk.
Authored by Phillip Skaggs, J.D., Berkley Life Sciences, Vice President & Chief Legal & Regulatory Affairs Officer
