The FDA's Social Media Guidelines Are Here … Were They Worth the Wait?

on YouTube about using one of its products and the content prompts questions about off-label use, this would be a solicited request. The FDA may consider solicited requests evidence of a firm’s intent that a drug be used for off-label purposes. 2. The guidance also distinguishes between non-public and public unsolicited requests and recommends appropriate responses. For example, a telephone call to a company’s medical affairs department is a non-public (private) request, and the response should be provided only to the individual who made the request in a one-onone communication. A question about off-label use that is posted on an Internet discussion board is considered a public request, and if a company chooses to respond, it should give contact information only; anything else could be misinterpreted by others in the forum as off-label promotion. The FDA is also concerned about publicly posted drug information, such as product risks, that might reside on the Internet indefinitely even after the information becomes outdated. 3. The guidance encourages drug companies to respond to unsolicited requests that are made in a public forum because other forum participants might not provide or have access to the most accurate, up-to-date information. 4. Companies should respond to unsolicited requests only if they pertain to that company’s own named product. 5. Responses to unsolicited requests should not be promotional in nature or tone, and they should not provide links to promotional content.