The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry titled, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” issued in June 2014. This revised draft guidance is not final nor is it in effect at this time” (here). The revision updates a draft guidance that is ten years old (yes, you read that right!). While FDA typically instructs readers that draft guidances are not official and cannot be implemented, we all know that draft guidances outline current Agency thinking. So, my view is that the enforcement policy outlined in the guidance regarding correcting misinformation was okay ten years ago, and that along with the rampant increase in misinformation, the revised guidance likely will permit firms to take advantage of this newly defined enforcement discretion, and the question of whether the guidance is in draft or final ultimately lands in the Agency’s lap anyway.
The new guidance introduces the concept of tailored responsive communications which the Agency defines as “a firm’s voluntary, internet-based communication that identifies and addresses internet-based misinformation about or related to the firm’s approved/cleared medical product when that misinformation is created or disseminated by an independent third party.” The document provides an extensive list of examples of those types of statements that may be made by independent third parties on social platforms that might be eligible for such interventions by firms to correct misinformation. They do not include simple opinions of third parties or individual experiences with a drug, biologic, or medical device but rather targets misinformation about adverse events or lack thereof, unapproved uses, as well as other more subtle statements. This document will shape the way firms can combat misinformation about an approved or cleared product without worrying about FDA reprisal.
This is one of the most comprehensive documents I have read on this topic and, while it does not cover all types of communication by independent third parties, it certainly provides the guardrails that should be followed to keep firms out of trouble in their responses to such misinformation. Let’s hope these guardrails keep firms squarely on the road (even though this is a DRAFT document).
