3 Things to Know

1)    On July 29, 2010 the FDA issued a warning letter to Novartis for the implementation of a Facebook share button and sharebar on the Tasigna product website.

2)    When the share button was clicked, it displayed a post on the user’s Facebook wall, which included the brand name and the indication, but did not include side effects and warnings (ie,no  fair balance). (Note: This display information is contained in hidden meta-data in the source code of the main website.)

3)    This FDA action in no way impacts pharma’s ability to use Facebook, social media or even share bars; this action reaffirms that there is no informal “one-click rule” and if you control the content you need to present fair balance.

3 Things to Do

1)    Make sure brand teams, regulatory review teams and agency partners know about meta-tags and this social sharing issue.

2)    Meta-data that includes the product name should not include the indication.

3)    Using share-functionality and Facebook Like buttons are still recommended, but your current implementations should be audited to ensure compliance with fair balance.