© 2012 Digitas Health. All rights reserved.
Facebook Commenting Enforcement Action
February 28, 2013
Analyst: Dale Cooke
On December 11, 2012, the Food and Drug Administration (FDA) issued a Warning Letter to AMARCEnterprises for promotional activity related to its Poly-MVA product
. FDA found that AMARC was promotingits product in such a manner that the product was a new drug for both human and veterinary uses, withouthaving received appropriate approval from the FDA for those uses and without having established the safetyand efficacy of the product for those uses. This enforcement action is relevant to pharmaceutical marketersprimarily because it is the first enforcement action from the FDA that explicitly discusses the “Like”functionality on Facebook, and it has been interpreted by certain commenters as establishing a precedent forfuture FDA enforcement action related to this functionality.In light of this enforcement action, Digitas Health recommends that companies take the following actions:1.
Ensure proper comment moderation is in place in online forums to remove potentially violativestatements2.
Review policies relating to activities by brands to ensure brands do not imply off-label usage oroverstatement of efficacy through their actions in social media venues (e.g., “Liking” violativeposts by others)
FDA has previously taken enforcement actions related to social media, including Facebook in particular
, butthis action is the first to explicitly address the use of the “Like” functionality. On Facebook, individual users(including companies and/or brands) post information. It is possible for other users to “Like” specific posts.Liking a post generates a message to a user’s followers that the particular piece of content has been liked.“Liking” a specific post or piece of content on Facebook is one form of endorsing content, but the generalprinciple of endorsing content is available more broadly across all social media channels (e.g., re-Tweeting aTweet on Twitter, Liking a video on YouTube). The AMARC enforcement action is noteworthy in that itexplicitly notes that one of the violative actions from AMARC is that a post was “liked” by a user.As described in the enforcement action, it is unclear exactly what was done. The Warning Letter descriptionis that:We also note claims made on your Facebook account accessible at:https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com.The following are examples of the claims:In a March 10, 2011 post which was “liked” by “Poly Mva”: “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped metremendously. It enabled me to keep cancer at bay without the use of chemo and radiation… Thankyou AMARC”
Based on this description, it is possible that the brand page put up a specific piece of content thatcontained the following claims: