Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their approved medical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 It supersedes the agency’s June 2014 draft guidance “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”
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that address internet-based misinformation related to approved/cleared medical products and comply with the revised draft guidance.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.
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FDA’s revised draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs” clarifies a safe harbor described in the 2014 draft guidance for companies voluntarily addressing misinformation on the internet and social media.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).
Continue reading…What is a “tailored responsive communication?” / General medical product communications / Concluding thoughts
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