The revised draft guidance sets out a policy to support health companies to address internet-based misinformation with tailored responsive communication.
The US Food and Drug Administration (FDA) has updated its official guidelines to address misinformation about medical devices and drugs spread by celebrities and online influencers. The new draft guidance, titled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” revises and replaces the earlier draft guidance issued in June 2014.
The FDA notes that not all information about medical products found on the internet is reliable; many false, inaccurate, or misleading statements are shared online. The structure and popularity of social media platforms have meant that false information about medical products can spread rapidly to a broad audience.
The revised draft guidance sets out a policy that supports companies to address internet-based misinformation related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, 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Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored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.
“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 We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation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 FDA has enhanced and expanded its social media presence and communications on the internet to inform public understanding and help improve awareness of the uses, benefits, and risks of FDA-regulated medical products. In 2022, the FDA launched the Rumor Control web page to combat the spread of health misinformation.
The FDA also encourages other interested parties to help the public get truthful, accurate, and scientifically sound information. “We are therefore issuing this revised draft guidance to describe avenues available to firms interested in addressing misinformation and to provide recommendations for firms that choose to voluntarily address internet-based misinformation about or related to their own approved or cleared medical products,” the FDA said. The revised draft guidance is open for public comment for 60 days.
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