Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age.
On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing industry with long-awaited insight into how the Agency views drug and biologic manufacturer regulatory obligations for social media marketing. The draft guidance defines interactive promotional media as “modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs.” Arguing that such forums do not fit neatly into the FDA regulatory framework for drug product promotion, industry has long sought guidance from the Agency as to how to comply with the law when taking advantage of new electronic promotional tools.
In the new draft guidance, FDA acknowledges the existing lack of clarity, and addresses one aspect of such compliance: postmarketing submission requirements. Specifically, the draft guidance outlines FDA’s approach for how firms can fulfill their postmarketing submission obligations in a practical manner, taking into account the potential volume of real-time information that is continually posted and shared through interactive media platforms. More importantly, the draft guidance also provides insight into the considerations FDA takes into account when determining whether a firm is responsible for product communications facilitated by interactive technologies, including user generated content. In this regard, although the draft guidance is directed toward drug and biologic compliance issues, it should be useful for medical device companies and other FDA-regulated industries as well.
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