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Social Sharing of Independent Promotional Material
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According to January’s FDA guidance, pharma companies are required to submit interactive promotional media for clearance if:
- the company is responsible for the production of promotional content on any site that it owns, controls, influences, or operates in any way;
- the company influences, reviews, previews, edits, or impacts the placement of any promotional material created and/or housed on third-party digital properties; or
- an agent of the company is responsible for any elements of the promotional material on any digital property (e.g., a tweet, Facebook post, blog, article comment, etc.).
This guidance suggests that pharma companies would not be responsible for submitting to the FDA independent promotional material posted by independent users on a company-run digital property. The guidance clarifies a wide range of scenarios a company may encounter during online promotion, but one key question remains.
If an independent user posts something on a company-run digital property, is the company able to share that content with others? For example, an independent blogger writes about her personal experience with Brand X on her personal website. She then posts a link on Brand X’s Facebook page. If the URL, post content, and article title are devoid of any promotional statements/claims, would Brand X be able to share that article with the rest of its followers on Brand X’s Facebook page? Similarly, if the blogger tweets a link to the article and mentions Brand X’s Twitter handle, would Brand X be able to re-tweet that article?
The FDA’s long-awaited guidance provides clarity in many ways, but it is only a first step toward comprehensive guidance on digital/social communication. By failing to address a brand’s ability/responsibility in sharing independent content, the FDA’s guidance implies that sharing is not yet safe for pharma companies. Without further clarification, one could argue that sharing falls under the umbrella of “influencing, reviewing, previewing, etc.” However, if the content in question was published publicly prior to sharing, one could argue that it is inherently uninfluenced. This is a big question, and the guidance does not provide an answer. For now, it is likely prudent to go by what the FDA says as opposed to what it does not.
 Guidance for Industry Fulfilling Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, FDA (January 2014) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf