Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.
“Regulated industry plays a critical role in ensuring consumers have accurate information about medical products. We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing,” said FDA Commissioner Robert M. Califf, M.D. “The growing spread of rumors about science and medicine continues to put patients and consumers at risk. We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”
In today’s health care system, health care providers and consumers often turn to the internet to obtain health and medical-related information. However, not all information found online about medical products is reliable. There are many false statements and conclusions shared online and the structure and popularity of social media platforms have meant that false, inaccurate and/or misleading information about medical products can spread rapidly to a broad audience. Basing medical decisions on inaccurate information can have adverse consequences as it can lead patients and health care providers to choose treatments that are not safe and effective, or to forgo treatments that are. The FDA believes it is critically important to promptly address misinformation about medical products. The revised draft guidance issued today supports the efforts of medical product companies that share this interest in helping the public get factual, accurate and scientifically sound information about medical products.
Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.
The revised draft guidance also describes existing avenues (“general medical product communications”) that companies might also choose to use to address misinformation about their medical products wherever that misinformation may appear. This draft guidance revises and replaces the draft guidance for industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, issued in June 2014. The revised draft guidance is open for public comment for 60 days.
In addition to providing these updated draft recommendations, the FDA has taken and will continue to take steps to communicate accurate, up-to-date, science-based information to the public. Some examples of such efforts include:
- Providing timely, digestible, factual information to news media and other organizations;
- Creating resources on the 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 memos and other regulatory documents that outline the agency’s decision-making, consistent with applicable law(s).
The FDA will continue to proactively offer resources about medical products to provide factual and scientifically sound information to the public. The agency remains committed to helping address misinformation and continues to support other interested parties that choose to engage on this critical issue.
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