The FDA recently proposed guidance for the submission of materials disseminated through real-time social media promotions (“Interactive Promotional Media”) for postmarketing reporting purposes.

Under existing FDA postmarketing reporting requirements, manufacturers, packers, and distributors that are FDA applicants or that act on behalf of FDA applicants (“Applicants”) are required to submit all promotional labeling and advertising pieces at the time of an advertisement’s initial publication.  The draft guidance provides nonbinding recommendations on how Applicants can satisfy the postmarketing reporting requirements while engaging customers through Interactive Promotional Media.

For a summary of the proposed guidance and a useful chart for Applicants, read the Mintz Levin alert authored by Cynthia J. Larose and Jonathan P. Ursprung.