FDA Draft Social Guidance


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Point of view of the recently released draft guidance for industry for pharma and social media by Navicor - an Oncology focused marketing and communications company.

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FDA Draft Social Guidance

  1. 1. January 2014 CORTHOUGHTS “...a firm generally is not responsible for UGC (User Generated Content) that is truly independent of the firm” It is time for comments! The FDA issues draft guidance on social media By Philip Storer On Monday, January 13, the FDA issued the long-awaited draft guidance for branded pharma products in social media. While much of the guidance speaks to “user-generated content” (UGC) and “realtime communications,” the FDA makes clear that these terms refer to “blogs, microblogs [Twitter], social networking sites [Facebook], online communities, and live podcasts.” Much of what the FDA said is a common-sense reiteration of what many of us have assumed about the responsibility of pharmaceutical companies. However, this guidance will help usher pharma into the next phase of online engagement.  The first thing to note about the draft guidance is that it is nonbinding and labeled specifically not for implementation. This draft is for the purpose of gathering comments. Pharmaceutical brand teams need to seek the counsel of their legal teams for final guidance on how their brands should proceed in engaging in social media. Navicor, in conjunction with the digital teams at inVentiv Health, is gathering input from digital strategists around the country to submit comments to the FDA. The information contained in this document should be considered Navicor’s interpretation of the draft guidance for the purposes of gathering and submitting comments.   The guidance can be broken into two main questions. First, what responsibilities do pharma companies have over the content generated on their pages? Second, how do pharma companies follow postmarketing reporting requirements when responding to UGC given that UGC is displayed in real time? To answer the first question, the FDA recognizes the difference between properties created by industry and thirdparty online properties such as Facebook, Twitter, YouTube, etc. In either case, the FDA states that pharma companies are responsible for content if they are “influencing or controlling” the promotional content whether “in whole or part.” This is a surprise to no one. What’s most interesting is the final portion of their answer to the question of responsibility. The FDA states, “a firm is responsible for the content INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER @ PHIL.STORER@NAVICORGROUP.COM
  2. 2. CORTHOUGHTS January 2014 It is time for comments! The FDA issues draft guidance on social media By Philip Storer generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.” While this may at first seem to surprise no one, the statement is further clarified: “A firm generally is not responsible for UGC that is truly independent of the firm.” This is the longawaited guidance that pharma needed in order to engage in a channel such as Facebook. Bryan Kaye, a digital strategist from Chandler Chicco, states, “This may be a game-changing statement for something that has been looming over the industry since the dawn of social media. It seems to mean that it is not the responsibility of the brand if a patient were to comment on a pharmaceutical branded product Facebook page or YouTube channel.” time communications.” The guidance goes on to clarify that pharma companies must submit to the FDA a monthly link to the site with a date range and a cross-reference of the most recent submission date and that this submission does not require screenshots. If, however, the UGC is behind a log-in and password, the pharma company must also submit all content related to the discussion and include screenshots of the site on a monthly basis. With this in mind, it is clear that pharma will be well served to ensure that all real-time communications remain publicly available, not behind a log-in.  The guidance for submitting third-party sites requires that pharma companies “submit the home page of the third-party site, along with the interactive page within The answer to the second question on the third-party site and the firm’s first how pharma is to follow postmarketing communication.” The guidance for monthly reporting requirements for UGC follows the submission then follows the same rules as same structure as the answer to the first sites owned by the pharma company. If the question. The FDA acknowledges that site is publicly available, pharma must there is a difference between online submit a name, URL, and date range on a properties owned by the pharmaceutical monthly basis. If the site is behind a log-in, company—such as your product.com— the content must be submitted in the same and online properties that can be way as described above for pharma.comconsidered third-party, such as Facebook, owned properties.  YouTube, Twitter, Blogger, SlideShare, etc. In addition to distinguishing between these While we must wait for the final guidance two types of online properties, the FDA to be issued by the FDA, it is encouraging further notes that it understands that some that the FDA is looking to provide clarity on of these properties require a log-in to view what pharma companies and their content, while others are publicly available. agencies are responsible for and how we After having made these distinctions, the are to submit. Undoubtedly, this will help draft guidance indicates that sites owned move pharma into the next phase of online by industry that include UGC are required customer engagement. to “include annotations to describe the parts that are interactive and allow for real- ABOUT THE AUTHOR Phil began his career in digital as a front end HTML/ CSS developer. Since making the switch to strategy, Phil has drawn on his technical background to lead digital projects for a diverse set of clients. He brings over 10 years of digital marketing experience to The Navicor Group. INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER @ PHIL.STORER@NAVICORGROUP.COM