The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their approved medical products posted by independent third parties. It supersedes the agency’s June 2014 draft guidance “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”
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Announcing the revised draft guidance, FDA Commissioner Robert M. Califf, M.D., expressed concern over a “growing spread of rumors about science and medicine [that] continues to put patients and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.
FDA states that it does not intend to enforce certain advertising, promotion, and labeling rules against a firm’s “tailored responsive communications,” i.e., internet-based communications that address internet-based misinformation related to approved/cleared medical products and comply with the revised draft guidance. The guidance separately describes how companies can use existing pathways (called “general medical product communications”) to address misinformation about their medical products on the internet or otherwise.
The revised draft guidance’s “tailored responsive communication” safe harbor applies to approved/cleared medical products: medical devices for human use (including those that are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 FDA’s interpretation of “independence” in this context was described in more detail in the 2014 draft guidance but continues to refer to material that is disseminated by a person or entity who is not acting on behalf of the company.
The revised draft guidance more clearly defines “misinformation” compared to the 2014 draft as “implicit or explicit false, inaccurate, or misleading representations of fact about or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 in several ways. For example, in relation to approved or unapproved uses of the firm’s approved/cleared medical product and related to instructions/directions for use from the FDA-required labeling of the firm’s approved/cleared medical product. Additionally, misrepresentations may be related to an attribute of the firm’s approved/cleared medical product that is independent of any particular use or that reflect scientific information about a medical product.
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.
Furthermore, 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.