In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a Questions and Answers draft guidance about how life science companies might respond to misinformation presented about their products by third parties.¹ Some of the significant changes from the previous 2014 guidance include:

1. FDA’s enforcement policy now extends to a company’s voluntary “tailored responsive communications” (to be discussed) that address misinformation suggesting a company’s approved product may be used for an unapproved use;
2. new content to reflect changes in technology and functionality of internet-based platforms and changes in the way information is shared online to help a company have greater flexibility and control over the timing of the firm’s communication; and
3. guidance on “general medical product communications” (to be discussed) that describes many avenues available to firms for communicating information about or related to their approved products.

In this Bulletin, we will highlight the major points, provide some of the examples offered by FDA, and include our own observations.²

Highlights

• “Misinformation” refers to implicit or explicit false, inaccurate, or misleading representations of fact about or related to a firm’s approved medical product.
• The guidance focuses on misinformation provided by third parties independently (i.e., not under the control of the drug or medical device company) and certain kinds of internet-based communications (tailored responsive communications) that firms might choose to use to address internet-based misinformation.
  • Company-controlled messages cannot provide false or misleading information; this type of activity is not covered by the Q&A 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 medical product when that misinformation is created or disseminated by an independent third party.
  • If a company uses a tailored responsive communication to address misinformation and follows the guidance, FDA does not intend to enforce any applicable requirements related to promotional communications and post-marketing submission of promotional communications.
  • If a company provides a tailored responsive communication that addresses misinformation about its product’s unapproved use and the tailored responsive communication is consistent with the guidance recommendations, FDA does not intend to use this type of communication, standing alone, as evidence of a new intended use.
• The enforcement policy applies when a company voluntarily shares an internet-based communication that identifies and addresses misinformation:
  • related to the firm’s approved medical product;
  • in an internet-based communication; and
  • created or disseminated by an independent third party.
• Television and radio advertisements are not covered by the enforcement policy.
• The enforcement policy does not extend to a company’s response to statements describing opinions or value statements about the product. It also does not extend to a response to representations about an individual patient’s experience (whether made by the patient or others).
  • E.g., An independent third party posts a video on social media that the influencer does not like Drug X, a prescription drug indicated to treat acne vulgaris, because it didn’t work for his acne vulgaris and suggests followers consider a different treatment. The statements represent a personal experience and value judgment.
• FDA provides an example involving internet-based, independent third-party communications that include misinformation where a company might decide to address it with a tailored responsive communication.
  • A third party posts on a personal social media account that Drug Class A (a class of drugs approved to lower low-density lipoprotein (“LDL”) cholesterol, as an adjunct to diet, in certain patients) has been shown to cause Alzheimer’s disease and, therefore, should not be used by patients to lower LDL. There is no evidence that drugs in Drug Class A cause Alzheimer’s disease, so the HCP’s statement is false, inaccurate, and misleading.
• A company’s tailored responsive communication should clearly identify both the specific misinformation that it is addressing and a specific internet-based, independent third-party communication where the misinformation appears.
• When a company identifies misinformation that is widespread, the firm should, at a minimum, clearly identify at least one internet-based, independent third-party communication that contains the misinformation, such as providing the date and specific location within the internet-based setting where the independent third-party communication was posted.
• A company should ensure that the information in the tailored responsive communication is:
  • truthful and accurate;
  • scientifically sound;³
  • 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. A firm cannot omit information that is material to the specific content of the tailored responsive communication.
• Companies should provide certain disclosures in a tailored responsive communication to give the appropriate context to understand the communication, such as:
  • a way to obtain a copy of the current FDA-required labeling (including FDA-approved patient labeling, if any);
  • the date the tailored responsive communication is posted (if a date is not automatically generated); and
  • a disclosure that the tailored responsive communication is being shared by the company or a representative.
    • “This information is being shared by [Firm X], the maker of [Medical Product Y].”
    • “This information is being shared on behalf of [Firm X], the maker of [Medical Product Y].”
• If a company wants to clarify misinformation that suggests the product’s unapproved use, FDA recommends issuing a statement that identifies the unapproved use, noting that the unapproved use has not been approved by FDA and that the safety and effectiveness of the product for the unapproved use has not been established.
  • E.g., “[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.”
• For tailored responsive communications that include both audio and visual components, FDA recommends that disclosures be presented in both the audio and in the text at the same time using the same words.
• The enforcement policy is not limited to when the tailored responsive communication is offered in the same internet-based setting where the identified misinformation appears. A firm may provide the tailored responsive communication in different or additional internet-based settings.
  • A company may choose to address misinformation that was shared through an internet-based blog by an independent third party, by posting a tailored responsive communication on several social media platforms where the firm has accounts for its medical product.
  • The firm must identify the specific misinformation to which it is responding and include a description of the specific location within the internet-based setting and the date of the independent third party’s blog post that contained the misinformation.
• Communications through existing avenues are collectively referred to as “general medical product communications,” unlike tailored responsive communications, where general medical product communications are not necessarily internet-based or intended to address specific identified internet-based misinformation.
  • General medical product communications can include, for example, content and messaging that address misinformation about a firm’s approved product.
  • Promotional communications that are truthful and non-misleading are a type of general medical product communication that can provide information about an approved medical product’s safety and effectiveness.
  • A company can prepare its promotional communications to be used in a number of settings, whether or not internet-based, to address misinformation.
    • This might include using HCPs in promotional communications directed to that audience, having a TV advertising campaign, or engaging an influencer to convey the message in internet-based settings.
• FDA recommends a number of operational and presentational considerations:
  • When a company decides to voluntarily address misinformation, it should focus on (1) misinformation that has current relevance (e.g., misinformation that is trending or actively spreading on internet-based platforms); and (2) misinformation that is being spread by independent third parties that have large follower bases or hold positions of trust because those users may have a wider range or a higher degree of influence.
  • Companies should also focus on the layout and format of platform controls to help ensure that the tailored responsive communication, including all disclosures, is clear and not obscured.

AGG Observations

• The revised guidance may apply in many cases, but it does not apply for company-controlled messaging forums. These venues, when controlled by the medical device or drug company, must provide only truthful and accurate information.
• There is no FDA requirement to correct misinformation presented by an independent third party. However, the guidance offers recommendations on how a company might handle such misinformation, if it chooses.
• We caution that a company intending to correct misinformation not turn the opportunity into promotional messaging. This is not the intent of the guidance and might trigger compliance with promotional requirements.
• In the aforementioned “Land of Confusion,” Genesis sang, “Now, did you read the news today? They say the danger’s gone away.” FDA is trying to help companies ensure that the news today about their products is accurate in order to push away the danger of misinformation.

[1] https://www.fda.gov/media/179827/download.

[2] This guidance revises and replaces the previous guidance for industry, which we summarized here.

[3] Any study or analysis that supports the tailored responsive communication, at a minimum, should meet generally accepted design and other methodological standards for the particular type of study or analysis performed (e.g., provide a clear description of the hypothesis stated and tested, acknowledge and account for potential bias, and meet generally accepted scientific standards for the type of study or analysis performed), taking into account established scientific principles.