This post was written by Jillian W. Riley.
FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance sheds light on how to comply with FDA’s postmarket submission requirements when interactive promotional media constantly changes. In laying out the criteria for how and when to submit interactive promotional media for postmarket review, FDA gives important insight into the type of social media promotion in which it is most interested.
What type of social media activity does FDA want to review?
The draft guidance provides several scenarios to consider when determining whether interactive promotional media should be submitted to FDA for review.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 FDA for review. If the content is both firm generated and user generated, 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. 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 postmarketing submission requirement, 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 FDA review, 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 the firm’s 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. 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 these materials be submitted to FDA when the social media sites change so frequently?
“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 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. 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 non-restricted 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, 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.
Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” are due April 14, 2014.