Key Takeaways:

• FDA released a Revised Draft Guidance document with recommended practices for combatting misinformation online.
• Firms may wish to issue tailored responsive communications to combat specific instances of internet-based misinformation as defined by FDA.
• FDA establishes an enforcement policy regarding tailored responsive communications which must fall within an outlined scope and include certain disclosures and disclaimers.

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Introduction

Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media allows for rapid sharing of inaccurate and misleading information across various platforms. Health misinformation is considered to be a serious threat to the public health, and addressing it is a top priority for public health officials. 

On July 8, 2024, the Food and Drug Administration (FDA) released a Draft Guidance document, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers Guidance for Industry (Revised Draft). This Draft Guidance replaces the FDA’s Draft Guidance for Industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (2014 Industry Guidance) which the Agency issued in June 2014. Both draft guidances provided recommendations for firms that choose to respond to misinformation about their FDA-approved or cleared medical products when the misinformation is created or disseminated by independent third parties.

FDA derives its authority to regulate the mechanisms that medical product firms can use to communicate about their products from the Food, Drug & Cosmetic Act (FDCA), Public Health Service Act (PHSA), and their implementing regulations (collectively, “FDA Authorities”). FDA issued the initial draft guidance 10 years ago to help firms respond, if they chose, to misinformation about their FDA-approved or cleared medical products, if the misinformation was created or disseminated by independent third parties on the internet or social media.

FDA issued the Revised Draft after considering stakeholder comments received in response to the 2014 Draft Guidance. The Draft Guidance proposes an enforcement policy regarding communications that seeks to combat misinformation so long as the communications meet criteria outlined in the Revised Draft. However, the recommendations and enforcement policy do not apply to communications used by firms to address misinformation regarding an emergency use authorized for the firm’s product under Section 564 of the FDCA (21 U.S.C. §§ 360bbb-3).

The Revised Draft defines several key terms, which form the basis of these policy recommendations. These definitions include:

• Misinformation, defined as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to the firm’s approved/cleared medical product.”
• A firm refers to the persons or entities that are “legally responsible” for labeling FDA-approved or cleared medical products. The definition in the Revised Draft encompasses “applicants, sponsors, manufacturers, packers, distributors, and any persons communicating on behalf of these entities.”
• Medical products are medical devices for human use (including biologics), prescription human drugs or biologics, or prescription animal drugs.
• FDA-required labeling refers to the labeling reviewed and approved by FDA during the medical product premarket review process. This includes Prescribing Information (PI) for a human drug (including a drug that is licensed as a biological product), carton labeling, container labels, and FDA-approved patient labeling. It also includes labeling FDA reviewed during device premarket authorization (PMA) application review, humanitarian device exemption (HDE) application review, or De Novo classification request. FDA-required labeling also includes the labeling for indications for use and other required labeling information related to devices subject to 510(k) premarket notification submission requirements and other devices exempt from premarket review.
• Independent third party refers to a person or entity that is communicating about a firm’s approved/cleared medical product but is not acting on behalf of that firm.

The Revised Draft distinguishes between two categories of communications – (1) tailored responsive communications and (2) general medical product communications and provides recommendations and hypothetical examples under each category to illustrate how firms can voluntarily respond to misinformation that was created or disseminated by an independent third party.

Tailored Responsive Communications

Tailored responsive communications are voluntary, internet-based communications that identify and address internet-based misinformation about or related to a firm’s approved/cleared medical product when that misinformation is created or disseminated by an independent third party. If done appropriately, these communications, per the Revised Draft, are not subject to regulatory requirements applicable to advertising and promotional labeling, including post-marketing submission requirements.

Below are some key points from the Revised Draft Guidance related to the scope of the enforcement discretion policy for tailored responsive communications:

• The firm’s product does not need to be identified in the misinformation and firms may publish tailored responsive communications about misinformation aimed at a class of products.
• TV and radio advertisements are outside of the scope of this enforcement policy, even when disseminated via the internet (e.g., during streamed programs). However, firms can share general medical product communications—including TV and radio advertisements—to “support diverse strategies for addressing misinformation.”
• In the case of misinformation about or related to unapproved uses of approved/cleared medical products, the enforcement policy limits a firm’s response to correcting misinformation created or disseminated by an independent third party that suggests that the firm’s approved/cleared medical product should be used for an unapproved use.
• The enforcement policy does not extend to a firm’s responses to statements describing opinions or value statements about a firm’s approved/cleared medical product.
• It also does not extend to a firm’s responses to representations about an individual patient’s experience using a firm’s approved/cleared medical product.

Through various examples, FDA clarifies a few key points regarding its enforcement policy and tailored product communications in response to misinformation:

• As stated above, responses to experience, opinion, and value judgments do not fall within the policy. The guidance provides various examples of online influencers describing their own use of a product or knowledge of another’s experience. The examples illustrate that responding to a communication that merely discusses the influencer’s experience regarding the effectiveness of the product or adverse events related to the use of the product would not fall within the enforcement policy.
• It may, however, be permissible to craft a tailored communication to respond to other types of statements made by an online influencer, such as comments that reference the use of the product in a manner that is inconsistent with the product’s approved use. The guidance provides examples where it would be appropriate to respond to statements made by an influential poster that the product poses a risk that is not supported by data or where popular online personalities promote uses of a product that contradict the instructions on the label. These statements affect how a product would be consumed and likely affect efficacy, adherence, and patient safety and are therefore the type of health misinformation that the policy seeks to address.

Guidelines for making tailored responsive communications:

• Tailored responsive communications should be truthful and accurate, scientifically sound, directly relevant to the identified misinformation, and limited to information necessary to address the identified misinformation as well as any recommended disclosures.
• Tailored responsive communications should clearly identify the specific misinformation that the firm is addressing — including the specific communication in which the misinformation appears. The firm may embed the original misinformation and include photos or video stills of the misinformation.
• Tailored responsive communications should be narrow in scope – i.e. they should merely correct product falsehoods and not veer outside the bounds of a specific correction.
• The communication should provide mechanisms for readers to obtain the product’s current FDA-required labeling along with the responsive communication’s date and a disclosure that the firm is behind the communication. Firms must also, when applicable, include disclaimers identifying any unapproved uses discussed in the tailored responsive communications and the misinformation it seeks to correct. The required disclosures and disclaimers must be clearly and prominently displayed and/or read.
• Firms may post tailored responsive communications across multiple platforms and are not limited to the platform(s) where the subject misinformation originated. FDA recommends that firms prioritize misinformation with current relevance (e.g. trending and rapidly spreading misinformation) and misinformation being spread by third parties with large followings and/or high degrees of influence. Firms should also consider how their tailored responsive communications – and their requisite disclosures and disclaimers – will appear when shared or reposted.

General Medical Product Communications

General medical product communications are the existing avenues that firms use to communicate information about or related to their FDA-approved or -cleared medical products. These can include sales aids, TV or radio advertisements, and institutional communications, among others. Unlike tailored responsive communications, these communications are not limited to internet-based platforms, nor are they solely prompted by or tailored to address specific identified internet-based misinformation.

The Revised Draft Guidance explains that firms may include content and messaging in their general medical product communications, including promotional communications, to address misinformation about their medical products. The guidance points to previously issued guidance documents with recommendations for sharing promotional communications that address misinformation more broadly. Promotional materials may, on top of their typical functions, serve as tools to combat product misinformation, but such communications are subject to existing FDA regulations and policies for promotional communications and not the Revised Draft enforcement policy.

The docket is open for public comments, which are due by September 9, 2024.