Below, we analyze the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products. 

“Tailored responsive communication” safe harbor

FDA’s revised draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs” clarifies a safe harbor described in the 2014 draft guidance for companies voluntarily addressing misinformation on the internet and social media. The agency says it does not intend to exercise enforcement  with respect to a “tailored responsive communication” that addresses misinformation. This safe harbor extends to FDA’s requirements related to:

• promotional labeling and advertising (collectively, promotional communications); and,

• postmarketing submission of promotional communications.

In addition, where the tailored responsive communication addresses misinformation that suggests that the firm’s approved/cleared medical product should be used for an unapproved use, and is consistent with the criteria set forth in this policy, FDA states it will not use that communication – standing alone – as evidence of promotion or commercialization of the product for a new (unapproved) “intended use.” FDA’s statement adds to the agency’s recent clarifications of what will and will not suffice to establish a manufacturer’s (or other party’s) intent to promote or market a regulated product for an unapproved use; for example, FDA published a final rule amending its “intended use” regulations in 2021, which we analyzed at that time online here.

Impetus for the updated policy

Announcing the revised draft guidance, FDA Commissioner Robert M. Califf, M.D., expressed concern over a “growing spread of rumors about science and medicine [that] continues to put patients and consumers at risk”. Dr. Califf cited other ongoing FDA efforts to communicate accurate, up-to-date, science-based information to the public (also echoed in the guidance), and to support and encourage all stakeholders in combating misinformation, including:

• FDA’s Rumor Control web page, which is focused on public health priorities and describes what information is accurate and what is a rumor, and how interested parties can help stop the spread of misinformation;
• Providing timely, digestible, factual information to news media and other organizations;
• Creating resources on FDA’s website and social media to address common questions about the products the agency regulates;
• Participating in speaking engagements to draw attention to the dangers of misinformation and to provide factual information about FDA-regulated medical products and public health issues;
• Providing interested parties with toolkits of resources; and
• Posting memoranda and other regulatory documents that outline the agency’s decision-making, consistent with applicable law(s).

What is a “tailored responsive communication?”

The revised draft guidance’s “tailored responsive communication” safe harbor applies to approved/cleared medical products: medical devices for human use (including those that are biological products), prescription human drugs (including biological products), and prescription animal drugs.  This includes medical products that are exempt from premarket notification or otherwise may be introduced into interstate commerce for at least one use.  FDA defines a “tailored responsive communication” as 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.  FDA’s interpretation of “independence” in this context was described in more detail in the 2014 draft guidance but continues to refer to material that is disseminated by a person or entity who is not acting on behalf of the company. 

The revised draft guidance more clearly defines “misinformation” compared to the 2014 draft as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to the firm’s approved/cleared medical product,” which includes false, inaccurate, or misleading representations:

• related to approved or unapproved uses of the firm’s approved/cleared medical product,

• related to instructions/directions for use from the FDA-required labeling of the firm’s approved/cleared medical product,

• related to an attribute of the firm’s approved/cleared medical product that is independent of any particular use (e.g., statements about where the product is made or about its components),

• that reflect scientific information about a medical product (e.g., about its risk, effectiveness, or mechanism of action; or are about the type, characteristics, or extent of scientific information about the approved/cleared medical product), or

• that omit a fact or facts that are material in light of the representations made or implied about or related to the firm’s approved/cleared medical product.

Critically, the misinformation need not specifically identify the product, but can relate to the class or category to which the product belongs.

As in the 2014 guidance, the revised draft guidance offers several instructive examples of tailored responses to false or misleading statements online that would not violate FDA’s advertising and promotion rules, as well as types of responses that would not be covered by the enforcement policy. Similar to the 2014 guidance and other guidance documents related to advertising and promotion of medical products, the revised draft guidance also emphasizes that  firms should ensure that the information in their tailored responsive communication is:

• Truthful and accurate
• Scientifically sound
• Directly relevant and responsive to the identified misinformation, and
• Limited to the information required to address the identified misinformation as well as any recommended disclosures.

The revised draft guidance adds a greater focus on social media and its public health implications compared to the 2014 guidance, recommending that firms who choose to respond prioritize addressing misinformation that has current relevance, such as because it is “trending or actively spreading on internet-based platforms”, and misinformation that is being shared by third parties who “have large follower bases or hold positions of trust, because those users may have a wider range or a higher degree of influence.” Notably, this comes after the Supreme Court ruled last month in Murthy v. Missouri that federal agencies can continue asking social media platforms to remove misinformation related to health care and other topics.

The revised draft guidance also narrowly characterizes the scope of the “tailored responsive communication” safe harbor. In particular:

• TV and radio advertisements are not within the scope of the enforcement policy, even when disseminated by firms via the internet (such as advertisements during streamed TV shows).

• The enforcement policy does not extend to responses to “opinions or value statements” about a company’s product, or representations about an individual patient’s experience using a product (e.g., an influencer says his wife is happy with the results of a drug).  It does, however, encompass responses to inaccurate or misleading assertions about the factual basis for such opinion/value statements (e.g., the influencer says his wife is happy with the results because there are no known side effects, which is false).

• A tailored responsive communication should identify a specific, independent third-party communication that it is addressing, as well as the specific misinformation being addressed.  When addressing misinformation that is purportedly “widespread,” the firm should, “at a minimum, clearly identify at least one internet-based, independent third-party communication that contains the misinformation the firm is addressing.”

• The communication should include certain disclosures, including a mechanism for obtaining copy of the FDA-approved labeling; the date the response was posted unless automatically generated by the platform on which the firm posted the response; and a disclosure that the information is being provided by or on behalf of the medical product firm.  These disclosures should be made “clearly and prominently,” based on factors such as “type size, style of font, layout, contrast, graphic design, headlines, spacing, volume, articulation, pace, and any other techniques to achieve emphasis or notice.”

General medical product communications

Separate from the “tailored responsive communications” safe harbor for internet-based communications, the revised draft guidance also advises on how medical device and drug firms may counter misinformation with a “general medical product communication.”  These communications are not necessarily internet-based, nor must they be prompted by or tailored to address specific identified internet-based misinformation. Unlike tailored responsive communications, general medical product communications must comply with all applicable FDA advertising and promotion rules.  Additionally, like any other communication by a drug/device manufacturer, they should be truthful, accurate, and scientifically sound. 

Concluding thoughts

Overall, the revised draft guidance is generally consistent with FDA’s prior published thinking on this topic.  Nevertheless, it describes the parameters of the safe harbor more clearly, expanding the scope of how a company may respond in some ways (e.g., not limiting responses to the same internet-based setting where the identified misinformation appeared).  It also provides a level of granularity in outlining agency recommendations/expectations in this area that could impact whether and how firms choose to respond to independent third-party communications. Additionally, this version of the guidance notably reflects more of a policy focus on the risks presented by the internet with respect to the potentially rapid and widespread dissemination of misinformation.  We will continue to monitor FDA’s activities in this area and keep you apprised of any changes.

FDA is seeking comments on the revised draft guidance by September 9, 2024.