FDA Issues Draft Guidance to Combat Misinformation about Medical Devices and Prescription Drugs
The U.S. Food and Drug Administration (FDA) has released updated draft guidance to help companies address the growing problem of misinformation surrounding medical devices and prescription drugs. This guidance, titled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” aims to equip companies with tools to counter inaccurate information spread online by third parties, such as celebrities, influencers, and healthcare providers not acting on the company’s behalf. The guidance outlines an enforcement policy that protects companies from certain FDA requirements when issuing specific responsive communications designed to correct misinformation. This policy applies to approved/cleared medical products, including 510(k)-exempt products, and certain other device categories. The new guidance replaces a 2014 draft that was never finalized, reflecting the increased urgency of combating misinformation, notably highlighted during the COVID-19 pandemic.
The FDA’s enforcement policy focuses on “tailored responsive communications,” which are internet-based communications created by companies specifically to address third-party misinformation. These communications can address misinformation appearing on various online platforms, including social media, podcasts, emails, and discussion forums. However, they cannot be delivered through traditional television or radio advertisements, even if disseminated online. The guidance defines “misinformation” as false, inaccurate, or misleading representations of fact about a company’s product, including misrepresentations of approved uses and omissions of material facts. The provided examples emphasize scenarios involving misinformation spread by influential figures, such as false claims about product-related injuries or inaccurate descriptions of approved uses. Importantly, the policy also covers misinformation about the general class of products to which a company’s product belongs.
To qualify for protection under the enforcement policy, tailored responsive communications must meet specific criteria: address third-party, internet-based misinformation; clearly identify the misinformation and its source; be truthful, accurate, scientifically sound, and directly relevant to the misinformation; include prominent disclosures, such as a link to FDA-required labeling, the date of the communication, identification of the company as the source, and, if applicable, a disclaimer regarding unapproved uses; and, for audio-visual communications, present disclosures in both audio and text simultaneously. The FDA emphasizes that these criteria are essential for the enforcement policy to apply. Failure to meet these requirements could leave a company’s communication outside the policy’s protection.
Beyond the core criteria, the FDA offers additional recommendations for effective responsive communications. These include prioritizing misinformation with current relevance and originating from influential sources, ensuring disclosures are not obscured by platform features, and considering how the communication might be shared across different online platforms. The guidance stresses that companies should confirm the entirety of their responsive communication, including disclosures, remains visible when shared on different platforms. These recommendations are presented as best practices rather than strict requirements for the enforcement policy’s application.
Companies have other options for addressing misinformation besides tailored responsive communications. They can still use general product communications, but these must adhere to all applicable FDA requirements for promotional labeling and advertising, as they would not fall under the enforcement policy’s protections. The guidance clarifies that compliant responses to misinformation, on their own, would not be considered evidence of a new intended use for the product. The FDA acknowledges that not all situations are clear-cut. For instance, determining what constitutes “scientifically accurate” and “directly relevant” information for a response can be challenging. Similarly, classifying certain statements as "misinformation" requires careful analysis. The guidance also raises questions about acceptable video platforms for tailored responses, given the exclusion of "television advertisements" disseminated online, particularly for shows exclusive to streaming services.
The draft guidance has a comment period closing on September 9, 2024, and offers a potentially significant shift in how companies address misinformation. By streamlining the applicable FDA regulations for tailored responsive communications, the guidance encourages companies to proactively combat misinformation without fear of enforcement actions, provided they adhere to the outlined recommendations. This approach acknowledges the seriousness of misinformation in the healthcare arena while establishing clear boundaries to prevent the corrective process from becoming a promotional tool. However, certain aspects, such as defining “scientifically accurate” or navigating platform-specific presentation issues, require further clarification. Industry stakeholders are encouraged to submit comments to the FDA regarding these and other ambiguities within the guidance.
While the draft guidance explicitly focuses on human medical devices (including biological products), human prescription drugs (including biological products), and prescription animal drugs, the FDA’s stance suggests a broader endorsement of similar initiatives for other regulated product categories, including over-the-counter drugs, food, dietary supplements, and cosmetics. However, it’s crucial to remember that the enforcement policy’s protections would not extend to communications about these other products. Companies addressing misinformation in these areas must carefully consider all relevant FDA and Federal Trade Commission (FTC) regulations. The FDA’s new draft guidance provides a framework for companies to proactively engage in the fight against misinformation, aiming to create a more informed and safer environment for consumers of medical products and prescription drugs. The ultimate effectiveness of this guidance will depend on its practical application and the collaborative efforts of companies and regulatory bodies.