FDA Updates Guidance on Internet-Based Medical Product Misinformation

The U.S. Food and Drug Administration has released revised draft guidance that aims to further empower organizations to address the spread of misinformation regarding medical products.

Healthcare providers and consumers often use the internet to gather health and medical-related information. But not all info found online about medical products is reliable—false statements and conclusions shared online as well as social medial popularity has helped spread false, accurate, and/or misleading info about medical products to a broad audience.

The revised draft guidance is entitled Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers. It outlines a policy to support companies that issue tailored responsive communications to address internet-based misinformation concerning their approved or cleared medical products when the misinformation is created by a third party.

For example, a company may use this communication when a chosen celebrity, healthcare provider, or influencer (not acting on the company’s behalf) posts deceptive representations of fact about a medical product on social media.

The revised draft guidance offers examples that show the types of misinformation found online a company may choose to address with a tailored responsive communication. It also includes considerations relevant to the current environment of digital information.

It also describes general medical product communications that companies can use to address misinformation about their medical products when that misinformation appears. The draft guidance replaces the industry draft guidance Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, released in June 2014. The agency said the revised draft guidance is open for public comment for 60 days.

“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 We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation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, MD. “The growing spread of rumors about science and medicine continues to put patients and consumers at risk. We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”