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FDA Empowers Companies to Address the Spread of Misinformation About Medical Devices and Prescription Drugs

social media misinformation

The FDA is advancing its mission to ensure the public has access to accurate, science-based information about medical products. Updated recommendations have been provided to help the industry voluntarily address misinformation about their approved products.

FDA Commissioner Robert M. Califf emphasized the industry's critical role in providing accurate information and noted the updated draft guidance offers clarity and flexibility for issuing proactive communications to counter misinformation. The rapid spread of false information online poses risks to patient safety, as it can lead to unsafe treatment decisions.

The revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers," supports companies in addressing internet-based misinformation created by independent third parties. For instance, a company might use this type of communication when a celebrity, healthcare provider, or influencer posts false or misleading information about the company’s medical product on social media. The guidance includes examples of misinformation that companies might choose to address and considerations relevant to the current digital information environment.

"Companies" refers to the persons or entities legally responsible for the labeling of approved/cleared medical products, which includes applicants, sponsors, manufacturers, packers, distributors, and any persons communicating on behalf of these entities.

The updated guidance also outlines existing methods ("general medical product communications") that companies can use to address misinformation wherever it appears. This revised draft guidance replaces the previous draft and is open for public comment for 60 days.

In addition to these updates, the FDA remains committed to communicating accurate, science-based information to the public. Efforts include:

  • Providing timely, factual information to news media and other organizations

  • Creating resources on the FDA’s 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

  • Offering toolkits of resources to interested parties

  • Posting memos and regulatory documents outlining the agency’s decisions

The FDA continues to proactively provide resources and support to ensure the public receives factual and scientifically sound information about medical products. The agency is dedicated to addressing misinformation and encourages others to engage in this critical effort.

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