FDA Drafts Guidance on Correcting “Misinformation”

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet final, the draft guidance provides long-awaited insight into the FDA’s approach to enforcement in this area, and it is worth considering for any company that encounters false or misleading statements about its products on social media or other online platforms.

Understanding the FDA’s Latest Draft Guidance

A key point to emphasize about the FDA’s latest draft guidance is that it is specific to companies’ efforts to address independent third-party statements about their medical devices or drugs. The FDA makes this clear in a footnote, stating “[t]his guidance is not intended to address a firm’s correction of its own false or misleading representations about its medical products.” The introduction to the guidance document also explains that, “[t]he recommendations and illustrative examples in this guidance are intended to help support firms that choose to address misinformation about or related to their approved/cleared medical products.”

The FDA’s draft guidance is broken into two subsections—Subsection IV.A and Subsection IV.B. In Subsection IV.A., the FDA provides recommendations for “tailored responsive communications,” or companies’ direct online responses to misleading third-party statements. In Subsection IV.B., the FDA discusses the use of “general medical product communications” as an alternate means of voluntarily addressing misleading third-party content utilizing existing channels.

Within each of these two subsections, the FDA’s draft guidance contains a series of hypothetical scenarios. Each of these hypothetical scenarios is accompanied by the FDA’s assessment of its implications for the company whose product is discussed. These implications range from the third-party communication at issue falling outside of the scope of the FDA’s draft guidance (though the FDA notes that these communications “could [still] be addressed with general medical product communications) to the possibility of issuing a tailored responsive communication containing certain FDA-recommended disclosures. These disclosures may include (but are not limited to):

• A mechanism for obtaining a copy of the FDA’s current required labeling for the medical device or drug at issue;

• The date of the company’s tailored responsive communication;

• Identification of the company as the maker of the medical device or drug at issue; and,

• A statement clarifying that a third party’s use of the medical device or drug at issue is unapproved.

The FDA’s draft guidance also addresses “operational and presentational considerations” related to tailored responsive communications online. For example, the draft guidance recommends that companies prioritize misinformation that, “has current relevance,” or that, “is being spread by independent third parties that have large follower bases or hold positions of trust.” Additionally, the draft guidance notes that if third parties may be able to share a company’s tailored responsive communication, the company should consider whether it is necessary to ensure that any shares include the entirety of the communication.

Contact Gardner Law for More Information

The FDA’s draft guidance addresses a number of other noteworthy topics as well. If you would like to know more, we invite you to get in touch. Please contact us to schedule an appointment with an FDA attorney at Gardner Law.