Facebook Commenting Enforcement Action

February 28, 2013 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
On December 11, 2012, the Food and Drug Administration (FDA) issued a Warning Letter to AMARC Enterprises for promotional activity related to its Poly-MVA product1. FDA found that AMARC was promoting its product in such a manner that the product was a new drug for both human and veterinary uses, without having received appropriate approval from the FDA for those uses and without having established the safety and efficacy of the product for those uses. This enforcement action is relevant to pharmaceutical marketers primarily 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 for future 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 violative statements 2. Review policies relating to activities by brands to ensure brands do not imply off-label usage or overstatement of efficacy through their actions in social media venues (e.g., Liking violative posts by others)

BACKGROUND
FDA has previously taken enforcement actions related to social media, including Facebook in particular2, but this 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 users 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 general principle of endorsing content is available more broadly across all social media channels (e.g., re-Tweeting a Tweet on Twitter, Liking a video on YouTube). The AMARC enforcement action is noteworthy in that it explicitly 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 description is 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 me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation Thank you AMARC

Based on this description, it is possible that the brand page put up a specific piece of content that contained the following claims:
2012 Digitas Health. All rights reserved.

PolyMVA has done wonders for me..it has helped me tremendously. It enabled me to keep 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 MVA brand page. It is also possible that the brand was the user named Poly Mva and liked that content either on the brands own page or on another page that was completely unrelated to AMARC Enterprises and Poly 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 brands user identification on Facebook, or it could simply have been a person 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 the Poly 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 certain key lessons. First, regardless of media, endorsing a claim about a product that overstates the products efficacy, broadens its indication, or otherwise is violative is itself violative. As stated above, the Warning Letter is ambiguous about whether user Poly Mva was associated with AMARC, but marketers should ensure that anyone who registers and has access to a user account closely associated with a brand name does not endorse via liking or other functionality any violative information regardless of its origination. In addition, companies are responsible for monitoring any material that is posted to a location that is controlled by the company. Based on the description of the Warning Letter, it is possible that another user posted the comment to the brands page, and that FDA is holding the brand accountable for that content. Appropriate moderation procedures can ensure that violative content is not posted by other users and receives tacit endorsement via its appearance on a companysponsored location. Regardless of the provenance of comments/posts on brand sites in social media venues, FDA is paying attention to the content of those comments. RECOMMENDATIONS 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 violative statements 2. Review policies relating to activities by brands to ensure brands do not imply off-label usage, overstatement of efficacy, or broadening of indication through their actions (e.g., Liking violative posts by others) in social media venues

February 28, 2013

Regulatory Alert: Facebook Commenting

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ENDNOTES
1

The Warning Letter is available online at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm340266.htm. Last accessed February 28, 2013. See See Digitas Health Regulatory Alert: FDAs First Facebook Enforcement Action, published August 5, 2010. Last accessed August 10, 2010 from http://www.scribd.com/doc/35466006/Digitas-HealthFacebook-Regulatory-Alert-20100805 for a discussion of the first FDA enforcement action regarding Facebook.

February 28, 2013

Regulatory Alert: Facebook Commenting

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