Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about prescription Drugs and Medical Devices, which is the focus of this post. The other, Internet/Social Media Limitations – Presenting Risk And Benefit Information for Prescription Drugs and Medical Devices, can be read about in another posting.
In keeping with the tradition of most of these releases, these guidelines are drafts and may change over time, but in reading them there are 5 key things digital marketers need to be aware of.
1. Brands may host open conversations on corporate-owned sites, without being responsible for the content.
This is surprising news, but the FDA’s own example for what its guidance entails opens the door for such communications. Beginning on line 141 the FDA writes,
“Example 4: A firm hosts a discussion forum about its drug’s or device’s FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by independent third parties and can, if it so chooses, correct misinformation according to this guidance.”
For years, brands have struggled with the possibility of hosting discussions, particularly as they relate to educating patients and interested parties about how to use or stay compliant with a particular product. This statement by the FDA indicates that that activity is now approved for consideration. One caveat, the guidance does not release the brand/corporation from monitoring for possible adverse event notifications, only stating that the brand/corporation is free from responsibility for the content being posted by independent third-parties. Read More…