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DH Regulatory Alert Facebook Commenting

DH Regulatory Alert Facebook Commenting

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Published by Dale Cooke
This Regulatory Alert discusses the FDA enforcement action against AMARC Enterprises for comments on its Facebook page. The alert provides recommendations regarding moderation and social media commenting policies.
This Regulatory Alert discusses the FDA enforcement action against AMARC Enterprises for comments on its Facebook page. The alert provides recommendations regarding moderation and social media commenting policies.

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categoriesBusiness/Law
Published by: Dale Cooke on Jul 30, 2013
Copyright:Attribution Non-commercial

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08/26/2013

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© 2012 Digitas Health. All rights reserved.
Regulatory Alert
 Facebook Commenting Enforcement Action
February 28, 2013
Analyst: Dale Cooke
 
EXECUTIVE SUMMARY
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
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. 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)
BACKGROUND
FDA has previously taken enforcement actions related to social media, including Facebook in particular
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, 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:
 
 
February 28, 2013 Regulatory Alert: Facebook Commenting Page2 of 3 
“PolyMVA has done wonders for me…..it has helped me tremendously. It enabled me tokeep cancer at bay without the use of chemo and radiation”Then, later, a user, who identified him/herself as “Poly Mva” “liked” that content on the Poly MVAbrand page.It is also possible that the brand was the user named “Poly Mva” and liked that content either onthe brand’s own page or on another page that was completely unrelated to AMARC Enterprises andPoly MVA. The Warning Letter is ambiguous between these descriptions.In addition, it is unclear whether the user identified as “Poly Mva” was at all connected to AMARC.That might have been the brand’s user identification on Facebook, or it could simply have been aperson who felt so strongly about his/her connection to the brand that he/she chose the user name“Poly Mva.” Nothing in the Warning Letter establishes whether AMARC had any connection to thePoly Mva user who liked the original post.
Implications
Because the violative content has been removed, it is not possible to recreate the exact scenario.Regardless, pharmaceutical marketers who are making use of social media can take away certainkey lessons.First, regardless of media, endorsing a claim about a product that overstates the product’sefficacy, broadens its indication, or otherwise is violative is itself violative. As stated above, theWarning Letter is ambiguous about whether user “Poly Mva” was associated with AMARC, butmarketers should ensure that anyone who registers and has access to a user account closelyassociated with a brand name does not endorse via liking or other functionality any violativeinformation regardless of its origination.In addition, companies are responsible for monitoring any material that is posted to a location thatis controlled by the company. Based on the description of the Warning Letter, it is possible thatanother user posted the comment to the brand’s page, and that FDA is holding the brandaccountable for that content. Appropriate moderation procedures can ensure that violative contentis not posted by other users and receives tacit endorsement via its appearance on a company-sponsored location. Regardless of the provenance of comments/posts on brand sites in social mediavenues, FDA is paying attention to the content of those comments.
RECOMMENDATIONS
In light of this enforcement action, Digitas Health recommends that companies take the followingactions:1.
 
Ensure proper comment moderation is in place in online forums to remove potentiallyviolative statements2.
 
Review policies relating to activities by brands to ensure brands do not imply off-labelusage, overstatement of efficacy, or broadening of indication through their actions(e.g., “Liking” violative posts by others) in social media venues

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