FDA Drafts New Policy to Combat False Information About Medical Products Online

Earlier this week, the U.S. Food and Drug Administration (FDA) released the draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs.” This document provides recommendations for medical product manufacturers on how to respond to false or misleading information circulating on social media and other online platforms.

The guidance introduces a policy for companies to issue specific types of internet-based communications, known as tailored responsive communications, to counter misinformation about their approved or cleared medical products when such misinformation is created or spread by independent third parties. For instance, a company might employ this approach if a celebrity, health-care provider, or influencer, not affiliated with the company, posts false or misleading information about their product on social media.

The draft guidance includes numerous examples illustrating the types of misinformation companies might address with tailored responsive communications, and offers considerations relevant to today’s digital information landscape. Additionally, it outlines existing methods, referred to as general medical product communications, that companies can use to address misinformation about their products, regardless of where they appear.

This new draft guidance revises and replaces the previous draft guidance issued in June 2014, and is open for public comment for 60 days.