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USFDA releases a new draft guidance to combat misinformation about medical products

The United States Food and Drug Administration (FDA) has issued a revised draft guidance for industry titled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." This paper, if completed, will provide the FDA's most recent perspective on typical questions companies may have regarding dealing with disinformation about their approved or cleared medical products. 

This amended guidance supersedes the prior draft, "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," which was released in June 2014. We have not finalised the revised draft and it is not currently in effect.

The FDA is requesting that the public submit comments on the proposed advice within 60 days of its publication in the federal register. The draft guidance also invites comments on the planned information collection until the same deadline. You can submit your comments electronically via the Federal eRulemaking Portal or in writing to the FDA's Dockets Management Staff.

Misinformation in the health field is a long-standing problem. The FDA has a history of dealing with similar issues, extending back to the AIDS epidemic in the 1980s, when the agency took action against a number of fake remedies. With the internet now serving as many people's primary source of health information, the distribution of inaccurate or misleading information regarding medical items has increased, particularly on social media platforms. 

The FDA works to battle disinformation through a variety of efforts. The FDA has increased its social media presence and online communications to promote public understanding of FDA-regulated medical products. It also employs speaking engagements, educational initiatives, and toolkits to disseminate factual information and combat misleading claims. 

The FDA developed the "Rumour Control" website in August 2022, with the aim of dispelling public health myths and providing accurate information. The FDA also uses webinars, email alerts, videos, podcasts, and medical device safety notifications to keep the public informed. 

The FDA stated that the amended draft guidance aims to offer companies recommendations for voluntary correction of internet-based disinformation about their medical products. The FDA emphasises the need to provide accurate and scientifically sound information for public health. The guidance encourages companies to dispel misconceptions and furnish customers with precise information about medical equipment and prescription medications.

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