FDA gives companies leeway to go after misinformation, but not free reign

Regulatory background: The FDA is responsible for overseeing information about regulated products.

• The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4 for medical devices as “the objective intent of the persons legally responsible for the labeling of” drugs of devices. In practice, the intended use of a product is the sponsor’s idea of how it will be used as outlined in approved labeling claims, marketing and advertising, and distribution of a product.
• A sponsor’s claims about the intended use of their product must align with the indications that the FDA has approved, cleared, granted, or otherwise authorized. Intended use includes such things as the condition or disease which the product is meant to treat, the population for whom it is intended, and the route, frequency of administration, and duration of use for the product.
• In addition to required labeling, the FDA also regulates certain advertising and promotional information made about the medical products by their sponsors. For drug products, the FDA regulates both product labeling (21 CFR 201) and promotional labeling (21 CFR 202). The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application and includes prescribing information (PI). Separately, “promotional labeling” includes any type of promotional material – including advertisements, informational brochures or other disseminated copy from the drug’s manufacturer, packer or distributor. Promotional labeling information must be submitted to the FDA “at the time of initial dissemination.” Notably, the FDA’s authority over advertising for medical devices is focused on “restricted” medical devices (i.e., those sold under authorization from a licensed provider or other regulatory-specific situations) and is submitted as part of the medical device’s listing (general controls), and the agency may request a copy of all advertising materials for good cause (See a Congressional Research Service explainer on this topic here).

Regulatory context: Not all information about drugs and devices is subject to FDA’s oversight, and the agency has struggled with the issue of “misinformation”

• FDA’s authority over claims made about medical products depends on the source of the claims. While life sciences firms are subject to the FDA’s regulations, the general public generally isn’t. As the FDA explained in a 2014 draft guidance document on correcting information from external sources, “the Internet and Internet-based technologies have made it easier for third parties who are independent of firms [i.e., sponsors, developers and manufacturers] to disseminate information about drugs and devices.” This information, which the agency called “user-generated content” (UGC) in that document, “might not always be accurate and may be dangerous or harmful to the public health.”
• That 2014 draft guidance was an initial step in the FDA looking to curb “misinformation,” which it defined in that document as “Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular.”
• Under the policy outlined in the 2014 draft guidance, firms would be able to “voluntarily correct” misinformation “in a truthful and non-misleading manner” without falling afoul of the labeling or advertising regulations cited above. FDA reasoned that it “may benefit the public health for firms to correct misinformation about their products.”
• At the time, the agency stated it wouldn’t consider certain methods (as described in that draft guidance) of correcting misinformation to be labeling or promotion: “FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any. If a firm chooses to respond to misinformation about its products using non-truthful or misleading information or in a manner other than that recommended in this draft guidance, however, FDA may object if the information provided by the firm does not comply with applicable regulatory requirements related to labeling or advertising, if any.” In general, the FDA stated that firms typically wouldn’t need to submit their “voluntary corrections” to the agency for review, but recommended they be kept in firm records.
• Industry’s reaction to the 2014 draft guidance was mixed. While industry concurred that online platforms could increase misinformation, they raised concerns with the FDA’s outlined approach, and in particular what would be expected of them. Medical device trade association AdvaMed noted that “the Internet universe is immense and no one entity can be expected to monitor the entire Internet,” highlighting industry’s limited ability to take on misinformation broadly. Further, both AdvaMed and trade association PhRMA mentioned complexities with misinformation that is “influenced” (in the FDA’s terms) by the firm’s available information, asking for clarity on the term. PhRMA also raised concerns that companies might be held responsible for misinformation that is out of their control. PhRMA went on to specifically question the regulatory categorization of these communications, noting that FDA “appears to recognize that some statements on social media correcting misinformation are neither “labeling” nor “advertising,” but fails to give guidance as to what kinds of statements would be regulated as such.”
• In effect: While the FDA said it would not be taking regulatory action against voluntary good faith efforts to “correct” misinformation, industry requested significantly more clarity about the applicability of FDA’s regulations, their responsibility to take action, and the scope of FDA’s authority and their requested activities.
• Notably, FDA never finalized its 2014 draft guidance. But since the guidance’s publication, battling misinformation has become a top priority for FDA Commissioner ROBERT CALIFF, who has referred to misinformation as a “leading cause of preventable death in America.” Notably, concerns about the societal and health impacts of misinformation have increased in recent years, with contributions from technology (artificial intelligence), communication (social media) and public health (the Covid-19 pandemic). For example, recent guidance from the National Institute of Standards and Technology (NIST) offered insights into how Generative AI could contribute to health care misinformation.
• FDA has been involved in several efforts related to misinformation in recent years, including attempts to better understand its causes and potential solutions. An October 2023 report from the Reagan-Udall Foundation – undertaken at Califf’s request – noted that “the spread of false information [has] accelerated in recent years, in part because more people than ever before are accessing information on the internet and via social media.” It also acknowledged industry’s concerns, and in particular that “efforts to “address” mis- and disinformation can, themselves, be misunderstood” and that reactive strategies (e.g., trying to correct misinformation as it comes) “is a terrible waste of time” (per public health experts). In the report, researchers recommended that FDA develop more resources internally for combatting misinformation – such as improving the process by which FDA responds to media inquiries and conducting message testing to identify better methods. FDA also launched a webpage called “ Rumor Control” intended to combat misinformation and rumors about FDA-regulated products.

FDA just published an updated version of its misinformation guidance. Let’s analyze what it says:

• The new version of the draft guidance (it’s a revised draft guidance, not a final guidance) was issued July 8, 2024. In addition to extensive revisions, the document has a new title; while the 2014 version was called “Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” the new version is simply called “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.”
• As the title implies, the guidance document is formatted in a Q&A style. The new document is about double the length (24 pages) as the 2014 document (12). Much of the document focuses on two general communication types: Tailored responsive communications, or “certain kinds of internet-based communications… that firms might choose to use to address internet-based misinformation” and general medical product communications, or the “already existing avenues for communications by firms under the FDA Authorities.” While the latter describes the current regulatory avenues for providing information about regulated products, the former offers a new enforcement discretion policy (i.e., the FDA will not enforce certain regulatory requirements, within the scope of the policy outlined in the revised draft document) for directly responding to misinformation, in certain circumstances.
• The revised draft document opens with a significantly expanded definition of “misinformation,” which it describes as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to the firm’s approved/cleared medical product” and then lists a bevy of examples of “false, inaccurate, or misleading” activities that would lead to those representations being “misinformation” – including information about approved or unapproved uses, instructions or directions, information “independent of any particular use,” scientific information or representations that “omit a fact or facts that are material in light of the representations made or implied about or related to” the regulated medical product.
• It also clarifies several different roles and entities under the policy: “Firms” are “persons or entities legally responsible for the labeling of approved/cleared medical products, which includes applicants, sponsors, manufacturers, packers, distributors, and any persons communicating on behalf of these entities.” An independent third party is “a person or entity that, in communicating about a firm’s approved/cleared medical product, is not acting on behalf of that firm.” The guidance focuses primarily on misinformation on the internet, with internet-based defined as “information available through the internet (regardless of whether that information originated on the internet). This includes, for example, information available via social media, podcasts, email (e.g., listserv), group messaging, and discussion forums.” The internet is considered a setting for the purposes of the guidance, with “setting” defined as “the location where content appears. Internet-based [as defined] settings include websites, internet-connected applications, platforms, or other internet-based media.” The up-front glossary in the new guidance also provides standard definitions related to a product’s approved use, an “unapproved use” (i.e., something not in the labeling), labeling and medical product.
• These are different from, but somewhat aligned with, the concepts presented in the 2014 version. The previous document had a slightly different (but far less detailed) definition of “misinformation” (“Positive or negative incorrect representations or implications about a firm’s product created or disseminated by independent third parties who are not under the firm’s control or influence and that is not produced by, or on behalf of, or prompted by the firm in any particular”). The 2024 version teases out the concept of the origin of information rather than including it in the definition of “misinformation,” instead separating out the definitions of “misinformation” and “independent third party.” Further, the 2014 version relies on the concept of “user generated content” or UGC, which is broadly defined as “information created by third parties.” This concept is not carried forward in the 2024 revised draft, with the FDA instead relying on its more-detailed definition of misinformation and establishing “settings” – “the location of where content appears” rather than its point of origin – with a unilateral focus on “internet-based” misinformation, and significantly expanded criteria for defining “misinformation” itself.

Tailored Responsive Communications: FDA’s thoughts on an enforcement policy for firms’ voluntary responses to misinformation

• The bulk of the new draft guidance is focused on the concept of “tailored responsive communications,” or a new enforcement discretion policy that would allow firms to directly respond to misinformation online. This content takes up most of the space in the new revised draft guidance (pages 11-21), including Questions 1-7 that define the concept of each key element of these communications, and what actions would be within or outside of the scope of the proposed enforcement discretion.
• What are “tailored responsive communications”? As defined in the revised draft guidance: “A tailored responsive communication is a firm’s voluntary, internet-based communication that identifies and addresses internet-based misinformation about or related to the firm’s approved/cleared medical product when that misinformation is created or disseminated by an independent third party.” In effect, they are the kinds of communications that a firm might make – on a voluntary basis – to directly address misinformation about their products. Aligning with the focus on “internet-based” misinformation, the FDA specifically notes that firms could only respond to misinformation via these communications in an “internet-based” way to be within the scope of the policy. As FDA explains, “the enforcement policy outlined in this guidance for firms’ tailored responsive communications does not include television (TV) and radio advertisements, even when disseminated by firms via the internet (such as during streamed TV shows)” (see footnote 8).
• The draft guidance offers an enforcement policy for these types of tailored, internet-based communications: The FDA “does not intend to enforce” (i.e., is proposing an enforcement discretion for) firms to respond to misinformation on the internet, via the internet, without running afoul of the labeling or promotional communication regulations as they’re typically enforced by the agency.
• There are three criteria for establishing whether misinformation can be responded to under the enforcement discretion. First, it should be “about or related to” a product from the firm. Second, it should be “in an internet-based communication.” And finally, it should finally be “created or disseminated by an independent third party” not related to the company. (All three criteria must be met.) Notably, the first criteria doesn’t require that a specific approved/cleared product be mentioned by name in the identified misinformation. “For example, the identified misinformation may include false information about an entire class of drugs or category of devices that includes a firm’s approved/cleared medical product (e.g., “statins cause earlobe enlargement”)” – or, perhaps more realistically, misinformation on the internet about vaccines.
• The FDA says it wants to err on the side of a narrow scope for this enforcement discretion: “it is important that this policy be drawn sufficiently narrowly so that it helps support firms’ voluntary efforts to address misinformation but does not undermine the purposes of those requirements” for labeling and promotion. As noted above, the policy in the guidance is focused on the internet, and does not extend to TV or radio advertisements; firms’ “tailored responsive communications” are solely an internet-based medium. Further, if a firm is responding to misinformation about an unapproved use, then their response must be focused on that unapproved use.
• Online information may or may not fit the definition of misinformation that can be responded to under this enforcement discretion.The key determining factor, and therefore scope of the policy, appears to focus on whether the information from third-parties aligns with the approved/cleared indications for the product. Third-party entities can have opinions or place value judgements about a product, but providing factually incorrect, inaccurate, or misleading information online would meet the definition of “misinformation.” The enforcement policy does not extend to statements about the value or opinions about their products – including “a firm’s responses to representations about an individual patient’s experience using a firm’s approved/cleared medical product (whether made by that patient or others).” The agency gives some examples of opinions or value statements in communications that are outside the scope of the policy (i.e., to which the firms cannot respond using tailored communications under the enforcement discretion), focused on “influencers” (including celebrities) that make content unsolicited by the firm about their experience with or opinions on specific medical products. These examples all relate to individual experiences or opinions within the scope of a product’s approval or clearance (e.g., personal anecdotal experience with a weight-loss or acne medication used as prescribed, or switching to a different version of a flea medication for dogs and opining that one is superior).
• However, there are also example of individual, third-party communications about experiences or opinions that would meet the definition of misinformation and therefore could be responded to via tailored responsive communications. The key differentiator of whether something is within or outside of the scope of the policy is whether the opinions presented are outside of the scope of the product’s labeling. The FDA provides nine examples of communications that are misinformation that would be able to be responded to via tailored responsive communication under the scope of the policy include (note: these are examples 4-13 in the guidance).
• The examples: 1) a health care provider posting on the internet about unsubstantiated claims that a class of cholesterol drugs causes Alzheimer’s; 2) a celebrity influencer recommending off-label use (i.e., uses not in the drug’s approved labeling) of a drug to prevent pregnancy as a post-exposure prophylactic; 3) a sports celebrity posting on the internet about a cold therapy device indicated for temporary relief of localized pain stating that the device is “cleared by FDA for use to accelerate healing and that anyone with an injury should use the device” beyond its indicated use, and against the safety recommendations in the labeling; 4) a blogger posting information that states that overdose reversal medications will cause the person administering the rescue measure to “overdose on opioids [them]self”; 5) a nurse posting online about a new drug approval that intimates that the drug is broadly approved when, in fact, the indication is specific and narrow; 6) an influencer posting in favor of a new drug but incorrectly stating that “there are no known side effects”; a doctor posting erroneously that “published studies” show serious injury associated with a medical device when no such studies exist; 7) a content creator making a video mischaracterizing evidence from early stages of drug development (i.e., in rats) to raise concerns about human effects; 8) a podcaster making an episode about an animal drug claiming it should be used for all animals with “any kind of allergy” when the drug is only approve for specific allergies in dogs; 9) an individual making a social media post that suggests a drug is made with cadaver tissue and is “a terrible choice for his dad.”
• Interestingly, in this last example, the assertion that a certain drug is a “terrible choice” is a value statement outside the definition of misinformation for the purposes of the guidance, but a misleading assertion about cadaver tissue being used in the drug’s manufacturing would make it subject to a response from the firm responsible for the drug under the enforcement discretion policy – so long as the response from the firm is within the bounds of a “tailored responsive communication” as defined.
• What goes into a “tailored responsive communication”? To comply with FDA’s policy, the firm’s response would need to “clearly identify” the specific communication to which it’s responding, as well as “the specific misinformation that the firm is addressing.” If “a firm identifies misinformation that is widespread,” then they should “clearly identify at least one internet-based, independent third-party communication that contains the misinformation the firm is addressing” – but can also note that the specific misinformation “appears on other social media platforms.” In effect: firms need to identify the source and the specific misinformation they’re addressing, including if they’re addressing “just one sentence of content posted by an independent third-party in a specific location within an internet-based setting.”
• The guidance goes on to lay out the specific elements of a “tailored responsive communication” – including the general information and approach (Q4) and “additional disclosures” (Q5). As a general approach, firm communications under this policy should be truthful and accurate, scientifically sound, directly relevant and responsive to the identified misinformation, and “limited to the information necessary to address the identified misinformation.” They should include any recommended disclosures (Q5) and can, if appropriate, include contact information for medical or scientific affairs staff for more information.
• The “additional disclosures” include a series of elements the agency recommends “to help ensure that audiences have the appropriate context to understand the communication.” These should include information on how to obtain the product’s labeling, dates of posting, disclosures about the firm itself (e.g., “this information is being shared by/on behalf of [Firm], maker of [Product]”), and information about the approval/clearance of the product – including statements identifying unapproved uses, if that is the subject of the misinformation. The tailored responsive communication should be shared via the internet, but the specific platform is not limited to the platform on which the specific misinformation is being shared. For example, if a firm identifies misinformation on a personal blog, they can issue their targeted responsive communication on “several social media platforms where the firm has accounts for its medical product.”
• Finally, Q7 is a bit of a catch-all, asking “are there any other operational and presentational considerations that FDA recommends” when considering or deploying tailored responsive communications. Unsurprisingly, the answer is “Yes, there are a number of observational and presentational considerations that FDA recommends a firm take into account.” These include recommendations on choosing which misinformation to respond to, such as prioritizing misinformation with “current relevance” and from sources with a long reach (e.g., large follower counts, higher degrees of influence). Sponsors are also asked to consider the platform(s) on which they might choose to share their communications, the layout and format of “platform controls” such as “engagement buttons” (for example, if the engagement buttons such as “share” or “like” will obscure one side of the communication when watched as a video, or a post caption that might be covering subtitles in a video), and how cross-posting across platforms will affect the communication.

General Medical Product Communications: Or, the currently-available methods under FDA’s authorities to provide information about regulated products

• This section takes up the final two pages of the guidance, and is only one question: Q8. “Can a firm address misinformation about or related to its approved/cleared medical product through existing avenues other than tailored responsive communications?”
• In this section, the agency generally recaps the existing policies related to promotional communications, which “often provide information about an approved/cleared medical product’s safety and effectiveness.” Per the guidance, promotional material can “address misinformation implicitly, without repeating or redirecting attention to that misinformation, or if preferred, the firm can call out the misinformation expressly, with the degree of specificity that it chooses.”
• Does that mean that “general medical product communications,” or currently available promotional material avenues, allow firms to directly address misinformation without the need to leverage the enforcement discretion detailed above? According to footnote 32, “While the enforcement policy outlined in this guidance includes recommendations for identifying the specific misinformation that a firm’s tailored responsive communication addresses, those recommendations do not restrict a firm from identifying misinformation with specificity in other types of communications that fall outside the scope of the enforcement policy outlined in this guidance,” including non-internet-based settings. This could allow for more “diverse strategies for addressing misinformation.”
• The agency points back to its existing resources on this topic, including 2018 guidance on medical product communications that are consistent with the FDA-required labeling, also known as the CFL guidance, and its 2023 guidance on presenting quantitative efficacy and risk information in direct-to-consumer promotional labeling and advertisements, or the Quant Info guidance. It also cites the (draft) October 2023 guidance on communications from firms to health care providers regarding scientific information on unapproved uses of approved/cleared medical products, or the SIUU guidance, which describes the FDA’s approach on “certain communications of scientific information on unapproved use(s) of approved/cleared medical products, which may be helpful in addressing misinformation” – particularly amongst health care providers. [Read AgencyIQ’s analysis here.] Finally, “it has long been FDA policy not to consider a firm’s presentation of truthful and non-misleading scientific information about unapproved uses at the planned sessions and presentations at medical or scientific conferences to be evidence of intended use when the presentation is made in non-promotional settings and is not accompanied by promotional communication” – per this FDA Memorandum from 2017.
• “Help-seeking” or institutional communications: These types of communications are generally separate from the promotional material regulations, and “are generally not subject to the FDA authorities” as they do not name specific products (or make suggestions about specific products). “Such communications are often used to provide information to raise awareness about diseases or general classes of available treatments,” the agency explains, and “may be helpful in addressing false, inaccurate, or misleading information about these topics.”

Analysis and what’s next

• The new enforcement discretion would provide a safe harbor for the life sciences industry to directly, and individually, respond to online misinformation. As is highlighted (albeit indirectly) in the guidance, “combatting misinformation” has been a key priority of FDA Commissioner ROBERT CALIFF throughout his current tenure – which may be drawing to a close, given the upcoming Presidential election. The guidance cites Califf’s remarks at five separate speaking engagements (footnote 20) as context for the agency’s approach here.
• A quick note: The concept of enforcement discretion means that FDA’s regulations are still in effect, but that firms operating within the specific scope of this guidance would not expect to be subject to enforcement action from the FDA if their activities would technically, legally fall afoul of the FDA’s labeling and promotional materials regulations. Any action outside of the scope of the policy detailed in the guidance would still be subject to enforcement – and enforcement discretion is, as the name implies, at the discretion of the FDA.
• The intent is similar to the 2014 guidance, but the mechanics are different. The new policy offered in the revised draft document is more detailed and specific, defining key terms and providing extensive examples and detailed language about the communications themselves (“tailored responsive communications”), the sources of potential misinformation (“independent third-parties”), the line between opinions/value judgements and misinformation, and how the setting where content appears matters to the type of action that a firm can take. Rather than addressing the more general, broad topic of misinformation on the internet, the new 2024 revised draft guidance seems to seek to carve out a specific umbrella under which the agency is, as the FDA’s email communications put it, “empower[ing] companies to address the spread of misinformation.”
• Does the new version address the concerns industry had with the 2014 version? Somewhat. As described above, trade association PhRMA sought significantly more clarity and granularity in definitions of key terms (including the types of statements and categorization of misinformation), which is certainly provided in the new 2024 revised draft. However, some other outstanding concerns – such as what responsibility the life sciences industry has to police online content from individuals in the endless-content-universe and respond individually, or whether the life sciences industry is the appropriate entity to combat public health misinformation from populations who may be skeptical of the industry writ large – remain unresolved. As noted above, public health experts have questioned whether one-off responses to misinformation in a reactive way (i.e., direct responses to misinformation posted by individual internet contributors) is a good use of time or resources, especially if the population targeted by the entity providing the scientifically factual information is pre-disposed to distrust of institutions like the FDA, public health, or “Big Pharma.”
• Who is misinformation from? The guidance focuses on the individual, but also directs firms to prioritize popularity. The guidance defines “independent third-party” as “a person or entity that, in communicating about a firm’s approved/cleared medical product, is not acting on behalf of that firm” (emphasis added). This raises questions about entities that are acting on behalf of another firm, or as part of a coordinated effort. The examples in the guidance all refer to individual actors, including personal social media accounts, personal blogs, individuals with podcasts, and celebrities (e.g., influencers, sports figures, “medical doctor[s] with a large social media following”). However, the guidance does not address any misinformation from organizations – other firms, political or advocacy groups, or any other coordinated effort; for example, there are no examples of misinformation from hypothetical anti-vaccine groups. The closest that the FDA gets to addressing this issue is that it asks firms to consider prioritizing responses to those “independent third-parties” with a broader reach. It’s not clear if this is because of the narrow scope of the guidance, or if the idea of “empowering” (in FDA’s words) the life sciences industry to more directly respond to coordinated public health risks at a broader level are beyond the intent of this policy.
• Will these policies support decreases in misinformation? Ultimately, the goal of addressing misinformation is to decrease its effects. However, the people who are most likely to be persuaded by misinformation are probably least likely to be receptive to information provided by the company that created the product that is subject to the misinformation. In fact, a “big pharma” company denying the accuracy of a claim may even serve to legitimize that claim in the eyes of some people. As a result, while FDA’s enforcement discretion policy does permit companies to address misinformation, it seems unlikely to many companies will choose to make use of this policy in the manner FDA intends. This is evidenced by the fact that relatively few companies have chosen to leverage FDA’s 2014 draft guidance document to respond to misleading claims about their products.
• Comments on the misinformation guidance are due October 29, 2024.

To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Alexander Gaffney ( agaffney@agencyiq.com)

Key Documents and Dates

• Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
• Comments due: October 29, 2024