1. FDA Social Media Draft Guidance - Overview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, , 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

2. FDA Social Media Draft Guidance – Overview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, , or fax within the company
Inquirer contacts company?
Yes
8/9/2019