FDA updates guidance to further empower companies to address the spread of misinformation

July 9, 2024
The revised draft guidance supports the efforts of medical product companies that share interest in helping the public get factual, accurate and scientifically sound information about medical products.

The U.S. Food and Drug Administration is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products. 

The revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain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 Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored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The revised draft guidance also describes existing avenues (“general medical product communications”) that companies might also choose to use to address misinformation about their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 This draft guidance revises and replaces the draft guidance for industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, issued in June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 The revised draft guidance is open for public comment for 60 days.

FDA release