FDA Issues Social Media Guidance, Sort Of…

Posted by: in Social Media Insights & Trends on January 14, 2014

The FDA has released draft guidelines for regulated healthcare companies on what they call Interactive Promotional Media. While not a comprehensive document about managing all social media content and channels, it is an important start on the road to clarity and the most direct guidance that the FDA has issued on the topic so far. And, according to John Mack, it looks like there is .

The outline the FDA’s definition of “interactive promotional media” and aim to help companies determine if their product communications using interactive technologies would be subject to the FDA’s post marketing submissions requirements. The womens ralph laure pony polo guidelines also make recommendations on how companies can submit materials for FDA review in a practical manner in the face of real-time information flow on social media platforms.

The latest draft guidelines provide some important insights about how the FDA looks at product promotion in the context of social media:

1. Be accountable for YOUR content (not external consumers): Good news for marketing teams and company regulators. There has been a fair amount of uncertainty on this point in the industry, which has probably been a key deterrent for brands to leverage social media channels in their marketing mix. While the FDA has provided more clarity on this, the definition of accountability is still quite broad, “A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.” In other words, this not only covers content generated by employees, but also content coming from people acting on behalf of the company (i.e. agencies, KOLs, contracted sales reps, etc). Despite this broad definition, this is the first time that the FDA has formally documented that they do not hold companies responsible for content they do not control.

2. The terms of engagement are “clearer”: With a few notable exceptions, brands have been watching online communities from the sidelines, not willing to engage for fear of crossing an invisible line with the FDA. The line has now been drawn, at least as it relates to promotional content shared by the advertiser, giving brands more clarity on what should be considered in and out of promotional jurisdiction, “…if a firm provides only financial support (e.g., though an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for the information on a third-party site and has no obligation to submit to the FDA.” In other words, if you share promotional content with 3rd parties (e.g. Influential bloggers) and they post something on their site as a result, your obligation is only to submit what you shared, not what they published.

3. Even your “brand-controlled” sites can allow engagement: The guidelines also take pains to clarify a company’s responsibility towards content that is disseminated by independent 3rd parties — even if it happens on the brand’s own facebook page/blog/forum, etc. “…a firm generally is not responsible for UGC [user-generated content] that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ralph lauren polo women ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.”

4. You can (cautiously) start your social media engines: Once a brand launches an interactive channel, it does not have to submit content for FDA review before it is disseminated through that channel, which further opens up the opportunity for brands to do real-time engagement (e.g. respond to Facebook posts, comment on a blog). The FDA makes it clear, however, that companies must collate all content they have developed and submit for review on a monthly basis.

Other key highlights from the guidelines center on the importance of transparency http://www.pureyeti.com.au/ when engaging in 3rd party channels as well as the continued need for fair balance in all product communications issued by the company, regardless of where these communications are disseminated. Finally, the document outlines the specific process, protocol and forms required for submitting all this content to the FDA.

Knowing that this draft guidance is actually part of a broader set of guidelines that the FDA will continue to release through July 2014 should provide some hope for brand teams. With the issuance of this first draft, it seems the FDA bit off the easiest and most manageable chunk first, but it will be important to continue to watch how these develop and evolve over time.

By: Colin Foster

With 20 years of experience in the marketing and communications space on both the client and agency side, Colin is a trusted innovator who can speak three languages (French, Spanish, and English), while remaining fluent in all things digital. As Managing Director of Twist Mktg, Colin stays focused on building out the firm’s footprint across the EU, US, APAC and key emerging markets. Colin currently juggles multiple healthcare, nonprofit and financial service accounts at commercial, corporate and R&D levels. Prior to jumping into the Twist world, Colin has lived in Argentina, Switzerland and has luckily (for us) landed in the US.

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