On January 13, the FDA issued draft guidance on the requirements for postmarketing submissions of interactive promotional media for drugs and biologics. The draft guidance provides valuable clarification of when the FDA will hold a company responsible for promotional content on social media.
The draft guidance defines “interactive promotional media” as “modern tools and technologies that often allow for real-time communications and interactions” (including blogs, microblogs, social networking sites, online communications, and live podcasts) used to promote a drug. The draft guidance states that product communications will be subject to postmarketing submission requirements if carried out directly by or on behalf of a manufacturer, packer, or distributer (a “firm”). A firm is accountable for product communications if the firm, or someone acting on its behalf, is “influencing or controlling the product promotional activity or communication in whole or part.”