Monday, July 15, 2024

FDA Tackles Medical Misinformation with Updated Guidance for Industry Stakeholders

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Misinformation is being actively addressed by the U.S. Food and Drug Administration (FDA) as it advances its mission to ensure the public has access to accurate, up-to-date, science-based information to inform decisions about FDA-regulated medical products and maintain and improve their health. To support this mission, the agency has provided updated recommendations to empower industry stakeholders to voluntarily address misinformation about their approved or cleared medical products.

FDA Commissioner Robert M. Califf, M.D., emphasized the critical role that regulated industries play in ensuring consumers receive accurate information about medical products. “We’ve updated our draft guidance to help further ensure the industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing,” Califf stated. He highlighted the growing threat of misinformation about science and medicine, which poses risks to patients and consumers. The FDA is committed to addressing this public health concern and encourages all parties in the public health ecosystem to take an active role.

In today’s healthcare system, both providers and consumers often turn to the internet for health and medical-related information. However, the reliability of online information varies greatly. False statements and conclusions are frequently shared online, and the structure and popularity of social media platforms allow misinformation about medical products to spread rapidly. This can lead to patients and healthcare providers making decisions based on inaccurate information, which may result in choosing treatments that are unsafe and ineffective or forgoing necessary treatments.

FDA Releases Revised Draft Guidance to Combat Misinformation on Medical Products

The FDA’s revised draft guidance, titled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” aims to support the efforts of medical product companies to help the public access factual, accurate, and scientifically sound information about medical products.

This guidance provides a policy framework for companies to issue tailored responsive communications to address internet-based misinformation created or disseminated by independent third parties. For example, if a celebrity, healthcare provider, or influencer posts false information about a company’s approved or cleared medical product on social media, the company can use this type of communication to correct the misinformation.

The revised draft guidance also offers numerous examples of the types of misinformation found online that a company might choose to address with tailored responsive communications. It provides considerations relevant to the current digital information environment and describes existing avenues, referred to as “general medical product communications,” that companies might use to address misinformation wherever it appears. This updated draft guidance replaces the 2014 draft guidance for the industry titled “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.” The revised draft guidance is open for public comment for 60 days.


FDA Enhances Efforts to Combat Misinformation and Provide Accurate Medical Information

In addition to these updated draft recommendations, the FDA is actively working to communicate accurate, science-based information to the public. Some of the FDA’s efforts include:

The FDA is committed to providing timely, digestible, factual information to news media and other organizations, creating resources on its website and social media to address common questions about regulated products, participating in speaking engagements to highlight the dangers of misinformation and provide factual information about FDA-regulated medical products and public health issues, offering toolkits of resources to interested parties, and posting memos and regulatory documents that outline the agency’s decision-making processes.

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The FDA remains proactive in offering resources about medical products to ensure the public receives factual and scientifically sound information. The agency is committed to helping address misinformation and supports other interested parties that choose to engage in this critical issue. Through these efforts, the FDA aims to enhance public understanding and trust in the medical products it regulates, ultimately contributing to better health outcomes.


Resource: Food and Drug Administration, July 08, 2024

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