The FDA draft ‘Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics‘ is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions1 of interactive promotional media for their FDA-approved products
For the purposes of this guidance, the phrase interactive promotional media includes modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, 23 social networking sites, online communities, and live podcasts) that firms use to promote their drugs. Although some interactive promotional media are substantially similar in presentation and content to certain traditional promotional media, such as print media, FDA recognizes that in other cases they possess certain unique technological features and offer novel presentation and content features. This draft guidance describes FDA’s current thinking on what the Agency considers to be interactive promotional media and outlines the considerations taken into account in determining if product communications using interactive technologies are subject to FDA’s postmarketing submission requirements.
Furthermore, this draft guidance provides FDA’s recommendations for how firms can fulfill the regulatory requirement to submit postmarketing promotional materials to the FDA in a practical manner to address the potential volume of real-time information that is continuously posted and shared through various interactive promotional media platforms.
The organization of the draft guidance is as follows: after some background information regarding postmarketing submission requirements (Section II), a brief legal overview of statutory and regulatory requirements for labeling and advertising is presented, including postmarketing submission requirements (III). Then, considerations related to submission of interactive promotional media are discussed with some illustrative examples (IV), and, finally, FDA’s recommendations for submitting such promotional materials are provided (V).
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