Law360, New York (January 28, 2014, 5:47 PM ET) -- The U.S. Food and Drug Administration has issued draft guidance addressing some of the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance sheds light on how to comply with the FDA’s post-market submission requirements when interactive promotional media constantly changes. In laying out the criteria for how and when to submit interactive promotional media for post-market review, the FDA gives important insight into the type of social media promotion in which it is most interested; namely, all of it.

The FDA’s post-market submission requirements include regulating promotional activities for currently marketed products. As part of these requirements, firms marketing FDA-approved drugs and FDA-licensed biologics must submit all promotional materials to the FDA. For labeling, the submission must be at the time of the initial dissemination and for advertising it must occur at the time of the initial publication. Firms fulfill this requirement by submitting a Form FDA 2253 for drugs for human use and a From FDA 2301 for prescription and over-the-counter animal drugs.

What Type of Social Media Activity Does the FDA Want to Review?

The draft guidance provides several scenarios to consider when determining whether interactive promotional media should be submitted to the FDA for review. The unifying theme appears to be the degree of control the firm can assert over the content of the website. 

The first scenario is where 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. This specifically includes Twitter and Facebook. The central question becomes “whether the firm, or anyone acting on its behalf, is influencing or controlling the promotional activities in whole or part.” Regardless of the scope of the influence, if the firm can exert any influence, it is responsible for the scope of the content and needs to submit that content to the FDA for review. If the content is both firm-generated and user-generated, the FDA still wants to see it.

The second scenario is where a firm is responsible for promotion on third-party sites. The same framework applies: whether the firm has any control or influence on the third-party site, regardless of the scope of that influence. The FDA distinguishes here between sites where the firm has editorial, preview or review privileges and sites where the firm only provides financial support and has no role in the information contained on the site, with only the former needing to be submitted for FDA review. As an example of content that needs to fulfill the post-marketing submission requirement, the FDA discusses a firm making suggestions regarding the placement of its promotional message on an independent third-party site. When submitting this type of content for review, the FDA wants to see the firm’s content in addition to the surrounding pages so as to provide adequate context for FDA’s review.

The third scenario is where a firm is responsible for content generated by an employee or agent who is acting on behalf of the firm to promote its product. This includes all user-generated content on any site if the user is acting on behalf of the firm. For example, a blogger writing on behalf of the firm or an employee or agent of the firm commenting on a third-party site about the firm’s product. The FDA recommends transparency for this type of communication; disclosing the firm’s involvement on a site by clearly identifying the user-generated content of its employees or agents.

How Should Materials be Submitted to the FDA When Social Media Constantly Change? 

“[The] FDA recognizes the challenges of submitting promotional materials that display real-time information” and provides a framework for how best to notify the agency of that promotional material.

• “At the time of initial display, a firm should submit in its entirety all sites for which it is responsible …” The firm should include annotations alerting the FDA to which parts of the site are interactive and allow for real-time communications. Any subsequent changes should be submitted when those changes are made. The FDA prefers to receive the submission in an archivable format that allows the agency to interact with the submission in the same way the end-user would. Screen shots or other visual representations are an acceptable alternative. 
• For third-party sites, at the time of the initial display, the firm should submit the home page of the site along with the interactive page within the site and the firm’s initial display.  
• “Once every month, a firm should submit an updated listing of all nonrestricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications.” As long as the site does not restrict access, these monthly submissions do not need to include screenshots, because, presumably, the FDA will be visiting these sites. Multiple sites and the corresponding document can be provided in one submission, with each site contained in separate document. Further, the firm should notify the agency when it ceases to be active on a particular site.
• For restricted access sites, “a firm should submit all content related to the discussion” in order for FDA to conduct an adequate review. This may or may not include independent user-generated content. Screenshots or other visual representations of the actual site, including all interactive or real-time communications, should be submitted monthly.

This draft guidance raises more questions than it answers. To pose just a few:

• Does the FDA have sufficient resources to conduct this type of monitoring? If firms continue to promote their products on interactive social media venues, will these new reporting requirements create an influx of promotional material for the FDA to review or will it streamline submissions and ease the FDA’s burden? 
• Are firms already submitting on a monthly basis or is this going to be a substantial shift in the frequency with which firms submit promotional materials to the FDA? While these requirements seem to be designed to alleviate the challenge of trying to fit social media promotion into a regulatory framework designed for static media, it remains to be seen whether this is enough of a shift to encourage industry to maintain active social media presence. These reporting requirements still appear to be somewhat onerous. For publicly available sites, firms must report to the FDA monthly. The burden is even greater for sites that are password protected because the monthly submissions require time-consuming screen shots.  
• What does “control or influence” mean? The guidance provides some insight: “[I]f the firm collaborates on or has editorial, preview or review privilege over the content provided” it has control or influence yet if the firm merely provides financial support then it does not. There is a lot of grey area in between those extremes and where the FDA draws the line as to the bounds of influence or control will be very interesting.  
• Will the lack of certainty around the definition of “influence or control” affect contractual arrangements between firms and their partner organizations? Will contracts begin to explicitly disclaim “influence or control”? Would such a contractual disclaimer matter to the FDA?  
• Will industry re-examine current policies around social media engagement in light of the draft guidance? The FDA does indicate it will exercise enforcement discretion if firms are complying with the draft guidance; will that be enough to encourage industry to take a hard look at its current social medial practices to ensure compliance? Will it be worth the investment? It will likely depend on the risk-aversion of the particular firm. 
• When can we expect additional guidance? What this guidance does not provide is clear direction as to permissible substance of social media promotion. Under the Food and Drug Administration Safety and Innovation Act, the FDA was given until July 2014 to issue guidance about the use of the Internet and social media to promote medical products. This current guidance addresses only a small segment of issues raised by such promotion. Two questions in particular remain unanswered:  

            1. How does this draft guidance operate with the off-label promotion guidance? 
            2. How can firms give full fair-balance to risks and benefits in the small space afforded by most social media? 

The FDA is soliciting comments on the guidance until April 14, 2014. Hopefully the final version will address some of these lingering issues.

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