What if a user posts false or misleading information about your product?

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The FDA has previously indicated that a pharma or medical device manufacturer is not legally responsible for user-generated content that may appear on social media sites.

The FDA recently published Guidance for Industry—Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

This guidance applies in circumstances where the manufacturer has no control over the content. Here are 2 examples cited by the FDA where this applies:

Example a:
A firm becomes aware of a blogger who is posting inaccurate information about the firm’s product. The blogger does not have a relationship with the firm and the firm does not compensate the blogger for the blog or for any other activity. The firm is not responsible for the content of the blog. The firm may decide to attempt to correct the misinformation, but it is not obligated to attempt to correct it.

Example b:
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.



Here are 2 examples where the manufacturer is responsible for the user generated content

Example c:
 As part of a marketing campaign, a member of a firm’s marketing department posts incorrect statements about a product’s safety or efficacy compared to the efficacy of a competitor’s product on a discussion board hosted by an independent third party. The firm is responsible for the content of the communication because the member of the firm’s marketing department is acting on behalf of the firm. Thus, this draft guidance would not apply.

Example d:
A firm hosts a discussion group on its own website, monitors the discussion for content that does not speak positively about its product, then removes or edits postings that portray its product in a negative light, and adds positive postings about the product. This firm is exerting control over the UGC and is responsible for the resulting content. Thus, the firm’s actions would not fall under the scope of this guidance.


Read the FDA document here:

Guidance for Industry Internet-Social Media Platforms- Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

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