FDA Guidance Tackles Off-Label Information Requests in the Digital Age
Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to public and non-public requests for off-label information about their products.
Now that online forums, email, social networking sites and other more advanced communication methods have become more widely used, the FDA has revised its approach to off-label information requests to take into account these new electronic communication methods.
The guidance reiterates the agency’s longstanding policy that a manufacturer’s responding to unsolicited requests for off-label information in such a way that suggests an unapproved intended use for the device in question is prohibited.
Public requests for off-label information
The FDA distinguishes between public unsolicited requests for off-label information—those made in public forums and directed either to an individual firm or to a wider forum—and non-public requests, which are directed privately to individual firms using one-on-one communication methods.
The guidance includes electronic communications under the public request category; consumers more often conduct online research on medical products and technologies, and off-label use questions from consumers are often seen by other online consumers as well as firms. Concerned that manufacturers may respond to individual requests for off-label data via online, public methods—particularly if those responses include intended use information that does not square with FDA approval—the agency recommends responding privately to any public request for such information. In the event that a firm opts to respond publicly, however, the FDA guidance provides the following suggestions:
- A firm should only reply to online public unsolicited off-label information requests in terms of specific information regarding its own products—not competitors’ products
- A firm’s public response to an information request should only consist of the firm’s contact details, not any off-label data
- Any representatives of manufacturers responding publicly to questions regarding off-label information should fully disclose their relationship to those manufacturers
- Public responses to such requests should not promote or market the device or manufacturer in question
Medical device industry participants have until March to submit comments on the FDA guidance. Assuming the guidance is implemented, what will manufacturers need to do in order to comply? An analysis by MDDI suggests firms revise standard operating procedures and policies regarding electronic communications, as well as potentially rope in regulatory affairs departments for any online and social media campaigns that could result in unsolicited off-label information requests—and FDA scrutiny.