Back in April, I wrote about social media marketing guidance provided by the FTC (Social Media Marketing – New Guidance On Generating “Buzz”).  Well, now it’s the FDA’s turn.  The FDA recently released draft guidance for pharmaceutical and biotech companies about how they should deal with misinformation posted by third parties on Internet and social media platforms.

Only a Draft

Its important to recognize that this guidance is provided only in draft.  Only when it is finalized will it represent the FDA’s then current thinking on this topic.  So perhaps the way to think about this is that is the FDA’s current thinking about what its final thinking will eventually be on the topic.

What Will the FDA Enforce?

Under the draft guidance, the FDA says that it will not go after a company that corrects misinformation in a truthful and non-misleading manner, even if the company’s  corrective information does not otherwise satisfy applicable labeling and advertising requirements.  Conversely, the FDA will go after a company that attempts to correct misinformation in a non-truthful or misleading manner.

What Posts Are Companies Responsible For?

The draft guidance proposes that companies should be responsible for posts (or other communications) that they “own, controlled, created or influenced, or affirmatively adopted or endorsed.”  Few would be confused or surprised to find that companies would be responsible for posts that they created or controlled.  Unfortunately, this quoted statement  from the draft guidance goes much further and the guidance does not expressly address its expansive breadth.

For example, if a company hosts a discussion forum and participation in the forum is conditioned upon the user’s agreement that the copyright in any content posted is owned by the company, then, under this guidance, the company would be responsible for third party user generated content that it neither created nor controlled, merely because it “owned” the property rights to it.

Similarly, on social media sites for brands, some brand owners frequently thank users for their posts to the site, without substantively commenting on the content of the post.  Query whether such a communication could constitute an “adoption” or “endorsement” of the substantive content of the post?  Presumably there would be a substantial risk that “liking” a post on Facebook could constitute such an adoption or endorsement.

Company Owned/Operated Platforms

Merely owning or operating a social media platform is not enough to make a company responsible for independent third party user generated content posted to the platform, under the draft guidance.  However, the FDA does provide that a company that exercises editorial control by removing only negative user generated content and posts positive content could become responsible for the user generated content on the site.

In either case, the guidance requires that such platforms include an “overarching clear and conspicuous statement that the firm did not create or control the user generated content.”

If You Correct One Post, Do You Have to Correct All Posts?

No.  Under the draft guidance, merely correcting one post does not make the company responsible for correctly all posts on a forum.  However, if a company is going to correct a portion of a forum, it must:

1.  Clearly identify the misinformation it is correcting;

2. Define the portion of the forum it is correcting; and

3.  Correct all misinformation contained in the defined portion of the forum.

The draft guidance is a little confusing on this point.  Notwithstanding the foregoing three requirements, the FDA goes on to suggest that, in certain circumstances, a company could still be responsible to correct misinformation in posts that are outside the scope of the well defined portion of the forum the company is undertaking to correct.  Specifically, the FDA provides an example where a company chooses to correct only selected posts and clearly defines the posts it is correcting.  However, the company does not correct other posts in the forum that contain exaggerated positive claims about the product.  In this case, the FDA guidance takes the position that the company is obligated to correct all posts that contain misinformation that are posted between the corrected posts. So, before you correct more than one post, you should probably read through all of the posts in between.  Unfortunately, this guidance may encourage companies to simply allow misinformation to remain posted to avoid inadvertently exposing themselves to liability for other posts they did not intend to address.

No Duty to Monitor/Report

The FDA clearly provides that it does not expect companies to continually monitor forums on which the company has previously corrected misinformation.  Similarly, the FDA does not require companies to submit corrections to the FDA.  However, the guidance does recommend that companies keep records of the misinformation that it corrects.

Where To Read For Yourself

If you want to read the draft guidance for yourself, you can find a copy here.