FDA Issues Revised Draft Guidance On Addressing Misinformation About Medical Devices And Prescription Drugs

On July 8, 2024, the U.S. Food and Drug Administration (FDA) issued updated draft guidance titled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (hereinafter "Misinformation Draft Guidance" or "draft guidance"). The Misinformation Draft Guidance provides recommendations for how companies can compliantly and voluntarily address misinformation about their "approved/cleared medical products" (notably, the draft guidance's definition of this term, and accordingly how this term is used in this Advisory, includes 510(k)-exempt products, as well as certain other categories of medical devices)¹ that has been created or disseminated via the internet by independent third parties, such as celebrities, influencers, and health care providers who are not acting on behalf of the company. The draft guidance would also set forth an FDA enforcement policy under which FDA would not enforce certain FDA requirements against tailored responsive communications issued by companies to address such misinformation, if those responsive communications meet the criteria specified by the Misinformation Draft Guidance.

The Misinformation Draft Guidance revises and replaces the draft guidance for industry titled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," which FDA issued 10 years ago in June 2014. Although FDA never finalized the 2014 version of the draft guidance, the importance of addressing misinformation about medical products received new urgency during and in the wake of the COVID-19 pandemic. FDA Commissioner Robert Califf has also spoken at length about the importance of combating misinformation about medical products, citing the public health harm that such misinformation can cause.

Below we describe the types of misinformation and voluntary communications that would be covered by the enforcement policy for tailored responsive communications to misinformation, review the information the draft guidance recommends companies include in tailored responsive communications, provide an overview of the draft guidance's other recommendations for how companies can address misinformation, and discuss key takeaways.

What Misinformation and Responsive Communications Are Covered by the Enforcement Policy?

The Misinformation Draft Guidance sets out an enforcement policy for "tailored responsive communications," which would include certain kinds of voluntary, "internet-based" communications that companies might use to address internet-based misinformation about or related to the company's approved/cleared medical product, when that misinformation is created or disseminated by an independent third party.

The draft guidance defines "internet-based" as information available through the internet (regardless of whether the information originated on the internet), such as information available via social media, podcasts, email (e.g., listserv), group messaging, and discussion forums. The draft guidance further notes that, to fit within the enforcement policy, the responsive communication cannot be issued by the company via a television or radio advertisement, even if disseminated by the company via the internet (such as during streamed TV shows).

The Misinformation Draft Guidance defines misinformation as "implicit or explicit false, inaccurate, or misleading representations of fact about or related to the company's approved/cleared medical product." This would include, among other things, representations of fact about or related to approved or unapproved uses of the company's product, and representations about the company's product that omit material facts. The draft also includes several examples that illustrate the types of misinformation that a company might choose to address with a tailored responsive communication, with a focus on misinformation created or disseminated by a celebrity, influencer, or health care provider. These examples include false or misleading allegations that published studies show a medical product is associated with certain severe injuries, or false or misleading descriptions of the approved use of the product.

Under the enforcement policy, FDA would not enforce applicable requirements related to promotional labeling and advertising, nor applicable requirements related to post-marketing submission to FDA of promotional communications, against tailored responsive communications issued by companies to address misinformation about or related to their approved/cleared medical products, as long as those communications meet the criteria described by the guidance. FDA also states that compliant responses to misinformation would also not, standing alone, constitute evidence of a new intended use.

FDA further clarifies that the enforcement policy is not limited to situations in which the company's approved/cleared medical product is explicitly named in the identified misinformation. Rather, the enforcement policy could also apply to misinformation about the class of products that includes the company's product (e.g., misinformation about statins generally, if the company has an FDA-approved statin drug).

Additionally, the enforcement policy would not be applicable to the extent that the company's responsive communication addresses an opinion or value statement, or addresses representations about an individual patient's experience using the company's product. The Misinformation Draft Guidance provides the statement "[my wife] is happy with the results and there are no known side effects of the drug" as an example of a representation that includes an opinion, value statement, and/or patient experience representation, and, as such, may qualify as misinformation under the enforcement policy. In that example, the company's response to the representation of "there are no known side effects of the drug" could fall under the enforcement policy, but any response by the company to the representation of "[my wife] is happy with the results" would not.

What Information Should Companies Include in Tailored Responsive Communications?

As described by the Misinformation Draft Guidance, for the enforcement policy to apply, the tailored responsive communication would need to do all of the following:

1. Address misinformation that was created or disseminated by an independent third party in an internet-based communication. The draft guidance defines "independent third party" as a "person or entity that, in communicating about a company's approved/cleared medical product, is not acting on behalf of that company."
2. Clearly identify both the specific misinformation that the company is addressing and at least one specific internet-based, independent third-party communication in which that misinformation appears.
3. 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.
4. Clearly and prominently include the following disclosures:
   • A mechanism for obtaining a copy of the current FDA-required labeling (including FDA-approved patient labeling, if any)
   • The date the company's tailored responsive communication is posted (if a date is not automatically generated)
   • A disclosure that the tailored responsive communication is being shared by the medical product company or that the person addressing the misinformation is providing information about the medical product on behalf of the company
   • If the responsive communication addresses misinformation that suggests that the company's approved/cleared medical product should be used for an unapproved use, the responsive communication includes a statement identifying the unapproved use or uses and noting that the unapproved use or uses of the medical product have not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use or uses has not been established. FDA suggests the following phrasing: "[Medical Product X] has not been approved by FDA for use in [Condition Y], and the safety and effectiveness of [Medical Product X] for [Condition Y] has not been established."

5. For responsive communications that have both audio and visual components, disclosures are presented in both the audio and in the text at the same time using the same words (either key terms and phrases, or a full transcript).

As noted, any responsive statement that fails to address the above criteria may fall outside of the protections of the enforcement policy.

Additional FDA Recommendations for Responsive Communications Issued To Address Misinformation

FDA also offers several operational and presentational considerations for companies to take into account when issuing responsive communications to address misinformation. The Misinformation Draft Guidance, unlike with respect to the criteria discussed above, does not explicitly condition the agency's application of the enforcement policy on adherence to these operational and presentational considerations.

These considerations include:

• Companies should prioritize addressing misinformation that has current relevance and that is being spread by independent third parties that have large follower bases or hold positions of trust.
• If the setting where a company chooses to post its tailored responsive communication has functionality that allows communications to be shared to other settings by users, the company should consider whether the shared version of its tailored responsive communication would include the entirety of the original post. The guidance proposes that a company either may choose to not enable sharing of its responsive communication on platforms that do not allow for entire responsive communication (e.g., including all applicable disclosures) to be displayed, or, alternatively, the company designs the responsive communication in such a way that the entire responsive communication will be displayed regardless of the platform.
• Companies should consider the layout and format of platform controls (e.g., engagement buttons) or other platform features (e.g., a platform's inclusion of the platform's logo) to help ensure that the company's tailored responsive communication, including all disclosures recommended in the draft guidance, are not obscured in the setting where the tailored responsive communication is being posted.

Finally, the Misinformation Draft Guidance affirms that companies are still able to address misinformation in ways that would not fall under the enforcement policy described by the guidance. For example, in addition to using tailored responsive communications, companies may also use general medical product communications to address misinformation. In such cases, however, companies would need to ensure all applicable FDA requirements are met, such as those relating to promotional labeling, advertising, and information on unapproved or uncleared uses, as such communications would not be protected by the enforcement policy.

Key Takeaways

If the Misinformation Draft Guidance is finalized, it may allow companies a degree of additional flexibility to respond to misinformation about their products in a relatively quick fashion, without enforcement risk when the communication follows the draft guidance recommendations. In particular, narrowing down the broad universe of potentially applicable FDA promotional requirements to just those specified by the guidance may streamline a company's development and dissemination of such communications. Overall, it is clear that FDA's concerns about misinformation have grown and companies are now encouraged to help address this serious problem, but within limits that avoid the correction becoming a promotional tool.

Nonetheless, certain criteria in the compliance policy may not always be straightforward to apply in practice. For example, determining what is scientifically accurate and directly relevant, and limiting responses to information necessary to address the identified misinformation, could prove difficult. Further, in certain cases, the question of whether a given representation meets the definition of "misinformation" as defined by the guidance may also require a nuanced analysis. Likewise, application of the presentational considerations described by the draft guidance would typically be a fact-specific exercise. It also may not necessarily be clear, at least at the margins, what types of internet-based video platforms and settings companies could use to share tailored responsive communications in video format under the enforcement policy since the enforcement policy would not apply to "television advertisements" disseminated via the internet, "such as during streamed TV shows." Ambiguity could arise, for example, if a show is only available on streaming platforms, or if a company designs a video-based communication to air only on the streaming version of a show. Industry stakeholders may want to consider submitting comments to seek clarification on these and other unclear aspects of the guidance that could pose practical challenges when drafting and disseminating tailored responsive communications to address misinformation.

While the recommendations in the Misinformation Draft Guidance are only directed towards medical devices for human use (including those that are biological products), prescription human drugs (including those that are biological products), and prescription animal drugs, FDA would likely also be supportive of similar efforts by companies to address misinformation about other FDA-regulated products, including OTC drugs, conventional food, dietary supplements, and cosmetics. That said, communications responding to misinformation for FDA-regulated products not covered by the draft guidance would not be protected by the enforcement policy, and thus communications addressing misinformation in such product areas should consider other potentially relevant FDA and Federal Trade Commission expectations for communications as well.

Footnote

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