INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER - Phil.Storer@navicorgroup.com

Correcting misinformation in social Another proposed guidance comes from the FDABy Philip StorerOn Tuesday, June 17, the FDA expanded their previously issued proposed guidance for social media by issuing a proposed guidance for industry on correcting misinformation for user-generated content (UGC). What may be as significant as the details of the guidance is that the guidance exists at all. The FDA’s continued focus on social media is signaling what many of us already know-- the internet is not simply the promotional channel of the future. Today, the internet is the epicenter of promotional activities in health care.  The guidance on correcting misinformation begins by stating that the FDA does not require industry to engage in the activity of correcting misinformation. The first sentence makes this clear by stating “…if they (industry) choose to respond….” With this in mind, many in industry may ask why they should engage in this activity at all. It is our POV that correcting misinformation is a matter of corporate responsibility. The FDA reinforces that idea by stating that they are providing guidance in concern for public safety and public health. One only needs to look at the recent outbreak of preventable diseases to understand the damage that has been done by the spread of

misinformation about vaccines in an age of nearly limitless online communications.  The details on how industry goes about correcting misinformation begins by reaffirming much of what was stated in the guidance on social media that was issued in January of this year. The FDA states several times that it does not hold a firm responsible for UCG that is “truly independent of the firm.” What is new in this particular detail is that the FDA states that firms “should include an overarching clear and conspicuous statement that the firm did not create or control the UGC.” The FDA provides 8 details on how to produce appropriate corrective information. The information should:  • Be relevant and responsive to the

misinformation• Be limited and tailored to the misinformation• Be nonpromotional in nature, tone, and

presentation• Be accurate• Be consistent with the FDA-required labeling

for the product• Be supported by sufficient evidence, including

substantial evidence, when appropriate

CORTHOUGHTS

“What may be as significant as the

details of the guidance is that

the guidance exists at all.”

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INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER - Phil.Storer@navicorgroup.com

• Be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or the corrective information should reference the misinformation and be intended to be posted in conjunction with the misinformation

• Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product

 The FDA also includes a somewhat surprising guidance on how to handle risk information. It is worth quoting them at length in order to understand the full context of the details on how to handle this content: “Because risk and other information about the product are not necessarily part of corrective information, the FDA-required labeling should be included or provided in a readily accessible format. As two examples, a firm may provide a link that goes directly to the FDA-required labeling or may provide a link that opens a new window to a portable document format (PDF) file. The information should not be provided by including

a link to a promotional website even if the information is available on the promotional website.”  Lastly, the guidance proposes instructions for industry after it has posted the correction. In summary, it is not the responsibility of the firm to follow up on any corrections, but it is the responsibility of the firm to keep a record of the correction.  One of the most fascinating impacts of this guidance is instruction for industry on how we ought to approach Wikipedia. The FDA states in Example 11 of the guidance that “A firm finds a webpage about its product that was written by an independent third party on an Internet-based, interactive, collaboratively edited encyclopedia. The firm may choose to contact the author of the webpage and provide corrective information to the author.” This is a task that all pharma brands ought to immediately consider, given the large influence that Wikipedia has on organic search results.

Correcting misinformation in social Another proposed guidance comes from the FDABy Philip Storer

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ABOUT THE AUTHOR Phil began his career as 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.