FDA Social Media Draft Guidance - Overview Unsolicited Request for Off-Label Information Public Non-Public If product name mentioned, then… Identify company and direct inquirer to a non-commercial phone, email, or fax within company Respond specifically in a non-public manner Public Non-public inquiries should not be answered with a public response Company Response FDA recognizes the pharma and medical device industries know how to respond to non-public inquiries with non-public responses Non-Public FDA recommends responding to all off-label inquiries in a specific, non-public manner 8/9/2019

FDA Social Media Draft Guidance – Overview Responding to unsolicited requests for off-label information Unsolicited request made Public forum? No Yes Respond in a non-public manner with truthful, balanced, non-misleading, non-promotional scientific or medical information Product named? No Take no action Yes No Identify company to inquirer, and direct to a non-commercial phone, email, or fax within the company Inquirer contacts company? Yes 8/9/2019