5 Key Takeaways From the FDA’s Draft Guidance On Correcting Independent Third-Party Misinformation



Yesterday the FDA released not one, but two documents providing draft guidance on the utilization of particular aspects of social media, entitled Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about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 Devicescan 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.

2. Any information provided by a brand to correct misinformation must be relevant, disclosed, non-promotional, and include a link to the appropriate product information.

Probably the most obvious take-away but needing specificity nonetheless, is that when brands do engage in correcting misinformation, they must do so in an accurate and non-promotional manner. Corrections should also include a link to the full product labeling or a link to open a PDF of that information in a new window. When correcting information, the brand/corporation must also correct any claims made by independent third parties that misrepresent both the positive and the negative. Failing to address both (if applicable) will run afoul of the guidance.

Additionally, when correcting misinformation, the person engaging in posting the contact must disclose their affiliation or relationship with the brand or product, to ensure transparency and ownership.

3. Brands / Corporations are not responsible for correcting every single instance of misinformation on a site, and not required to correct information if found.

If a brand / corporation finds misinformation posted on a website by an independent third party, it is not required by the FDA to correct it. If the brand/corporation choses to do so, it may correct information in specific places or posts, but not correct every single posting on a site that may be incorrect.

For instance, if a brand finds a comment thread containing 5 posts that misrepresent their product information, the brand may choose to provide corrected information to one of those comments, and not provide corrections to the other posts. When correcting the information, the brand/corporation must follow the guidance for appropriate corrections, but is not obligated to correct every instance that it finds.

4. Brands /Corporations are not required to monitor corrections once they are posted.

Once corrected information is provided by a brand or corporation, it does not have to continuously monitor subsequent posts or comments. This is a helpful clarification from FDA as it has been long since supposed that once a brand/corporation engaged in a thread it would become a “branded” property and therefore require continuous oversight.

In instances where content is controlled by an independent third-party, a brand/corporation is not responsible for any inaction on the third-party’s part in failing to correct any information, if the opportunity to do so is suggested. If a blogger is contacted by a representative of a product and asked to correct misleading information on their site and refuses to do so, the product in question is not responsible for the inaction of the blogger.

5. Wikipedia is now very much in play.

Wikipedia is the 3rd most referenced site by physicians, and the 2nd most by patients. The information about pharmaceutical products is almost always out of date, missing key information, or outright incorrect. The guidance makes it clear to pharma that FDA is giving them the green light to have a role in ensuring the accuracy of information on sites like Wikipedia.


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