Navigating FDA Guidance on Facebook and Social Media

The FDA recently warned AMARC Enterprises, Inc., a California-based dietary supplement company, that its Facebook page ( was not in compliance with FDA guidelines. Poly MVA, the AMARC brand name used on Facebook, inappropriately “liked” a consumer testimonial, the FDA’s December, 2012 warning letter noted. The consumer post read, in part, “Poly MVA … enabled me to keep cancer at bay without the use of chemo and radiation.” The agency further criticized a May, 2010 Facebook posting that offered information on how supplement ingredients, “… can nutritionally support the body during cancer and cancer therapy.”  Criticism of Poly MVA’s use of social media comes at the end  of a long list of other FDA violations, all revolving around failure to comply with various aspects of the Federal Food, Drug, and Cosmetic Act (FDCA).

Drug and Device Company Use of Social Media

Of course, many pharmaceutical and device companies maintain an active presence on Facebook, LinkedIn, Twitter, and other forms of social media. The FDA appears not so much as objecting to the use of the medium as much as it is reminding these companies that their social media policies must conform to established FDA guidelines.  Restrictions on patient and doctor communications in regard to off-label marketing, warnings, appropriate usage, and other health considerations must be adhered to whatever the form of delivery.

Reading closely, the FDA reprimand relates to how AMARC used its Facebook page to “like” a favorable consumer testimonial. It does not restrict consumers from “liking” a drug company’s Facebook page or posts.  For example, the Pfizer Facebook page has 65,000 “likes” as of this writing, while the Merck Facebook page has over 7,700 “likes.”

The pharmaceutical and medical device industries are anxious to receive further social media guidance from the FDA, which has been viewed as slow in responding to technological advances on social media platforms.  Although the Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices issued in December, 2011, addressed, in part, FDA’s thoughts on unsolicited requests for off-label information received (via electronic media as well as more traditional forms of communication), much more guidance is necessary. Drug marketers may need to wait as late as a July 9, 2014 deadline, however, for more detailed FDA guidance on allowable medical product promotions via the Internet and social media.

Leading Industry Practices in Social Media Management – What Others Are Doing 

A visit to the Facebook pages of pharmaceutical leaders like Pfizer, Merck, and Sanofi reveal highly visible communications policies that deal with the social media question head-on. For example, Pfizer maintains a detailed editorial policy page, notifying visitors that it can and will remove consumer comments or posts that are determined to be inappropriate due to content, including but not limited to a brand name, medical advice, side effects, or vulgarity. The Sanofi Facebook page includes an 11-point notice labeled “Rules of Engagement,” including disclaimers and a broadly defined licensing provision.

The bottom line lesson for drug and device companies is to review their social media policies carefully. Continuous oversight and monitoring of Facebook and LinkedIn is essential, while microblogging services like Twitter should be avoided due to the 140-character limitation, which limits a company’s ability to post or reply in accordance with FDA guidance and its own policies. The FDA’s warning to AMARC and the policies and actions taken by leading pharmaceutical companies provide valuable guidance to companies still struggling on how to navigate the social media minefield that the internet age has wrought.



About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

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