On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and examples for firms who choose to address misinformation about or related to their approved or cleared drug or device.[1] This guidance revises and replaces FDA’s 2014 draft guidance titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” Social media users from 2014 will appreciate how different the world looks today and why—even though it took FDA ten years—this revision is a welcomed shift making it more straightforward for firms to respond to misinformation.

Notable Updates and Similarities

New Terminology and Definitions

The guidance provides updated definitions of key terminology, and introduces the category of “tailored responsive communications” which are defined as 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.” While the 2014 draft guidance generally refers to “communications” created by firms, the introduction of the new term “tailored responsive communication” creates a distinction from already existing avenues for communications, or “general medical product communications”, which are not necessarily internet-based or intended to address specific internet-based misinformation.

The guidance also expands the definition of “misinformation” from “positive or negative incorrect representations or implications” to implicit or explicit false, inaccurate, or misleading representations of fact about or related to an approved/cleared medical product. This can include false, inaccurate, or misleading representations:

• of fact about or related to approved or unapproved uses of the firm’s approved/cleared medical product,
• about or related to an attribute of the firm’s approved/cleared medical product that is independent of any particular use,
• of scientific information about or related to the firm’s approved/cleared medical product, and
• that omit material facts.

Examples of Addressing Misinformation

The guidance assists firms in identifying the types of misinformation that might be addressed with a tailored responsive communication as well as communications which would be outside the scope of the outlined enforcement policy. FDA refers to these categorizations as the guidance’s “enforcement policy.” Under the enforcement policy, which is largely consistent with the 2014 guidance, if a firm shares a tailored responsive communication in accordance with the guidance’s recommendations, FDA does not intend to enforce:

• applicable requirements related to promotional label and advertising, or
• applicable requirements related to postmarketing submission of promotional communication.

FDA also clarifies that when a tailored responsive communication addresses misinformation regarding unapproved uses and is consistent with the guidance, FDA does not intend to use such communication as evidence of a new intended use. The enforcement policy is applicable even if the firm’s approved/cleared medical product is not explicitly named in the identified misinformation, such as when an entire class of drugs or category of devices are identified. A firm could use a tailored responsive communication if its medical product is included in the class of products identified in the misinformation.

While the enforcement policy is largely consistent with the 2014 guidance, the guidance provides additional details regarding the scope of the enforcement policy and when it may or may not apply. As highlighted by specific examples, the enforcement policy only applies to misinformation disseminated by an independent third party and does not apply to:

• a firm’s responses to statements describing opinions or value statements about a medical product, or
• a firm’s responses to representations about an individual patient’s experience.

The revised guidance provides additional examples of communications that include opinions, value statements, or representations about an individual patient’s experience such that a firm’s response would not fall within the scope of the guidance.

Similarly, the guidance provides multiple examples of internet-based, independent third-party communications that do include misinformation and could be addressed with a tailored responsive communication. Both types of examples are reflective of the rapid development in technology since the 2014 guidance was issued, and incorporate scenarios involving, for example, social media and podcasts. The guidance also clarifies that a tailored responsive communication should identify the specific communication being addressed and the specific misinformation in that communication that the firm is addressing.

Information Included In a Tailored Responsive Communications

FDA revises the characteristics of the information that should be included in a tailored responsive communication to offer additional flexibility to firms when responding to misinformation. Information in a tailored responsive communication 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 as well as any recommended disclosures.

Additional Disclosures

Notably, the guidance expands on the additional disclosures which should be included in a tailored responsive communication for purposes of the guidance’s enforcement policy. Such disclosures include:

• a mechanism for obtaining a copy of the current FDA-required labeling,
• the date the firm’s tailored responsive communication is posted,
• a statement that the information is being by the firm, and
• in cases of misinformation regarding use of an approved/cleared product for unapproved use, a statement identifying the unapproved use(s) and noting that the unapproved use has not been approved by FDA and safety/effectiveness for the unapproved use has not been established.

Additional Clarifying Information

FDA also clarifies that the enforcement policy in the guidance could apply when a firm shares their tailored responsive communication in a different or additional internet-based setting from where the identified misinformation appears. FDA also states that operational presentational considerations should be taken into account in a tailored responsive communication. For example, misinformation that has current relevance or that is being spread by those with large follower bases or positions of trust should be prioritized. The layout, format, and portability of the internet-based setting in which a tailored responsive communication is made should also be considered.

General Medical Product Communications

The guidance reaffirms that firms can use “general medical product communications”, and these types of communications can include promotional communications. FDA also highlights other guidance documents it has issued which could be relevant to firms when addressing misinformation. Lastly, the guidance notes that “help-seeking” or “institutional” communications, which do not name or refer to a specific medical product and are distinct from promotional communications, can provide information to raise awareness about diseases or general classes of treatment.

Key Takeaways and Industry Impact

The revised guidance is reflective of FDA’s and Commissioner Califf’s priority to combat misinformation, and the revised guidance provides a clearer roadmap and additional flexibilities for firms who choose to address misinformation about their products. Ultimately, the enforcement policy is quite an expansion of the 2014 guidance, broadening the definition of what is “in play” from a communication counteraction perspective and making it easier to launch the responsive communication itself. Indeed, by incorporating additional examples on when tailored responsive communications could be used, FDA opens the aperture by providing a clearer pathway with steps for firms addressing misinformation. No longer must firms go to great lengths in identifying untruths or inaccuracies and making a responsive communication within the same medium.

The clarifications around the enforcement policy set forth in this guidance may not end up resulting in overhauls of big company corporate communication policies, but the new approach could result in additional opportunities for smaller firms with limited resources and/or fewer approved/cleared products to combat misinformation. To be sure, the devil is in the details when deciding whether—under the previous and certainly this new guidance—to make a responsive communication, but now, there are more options. Comments may be submitted until September 9, 2024.

FOOTNOTES

[1] FDA, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” (Jul. 8, 2024)