Overview

Pharmaceutical marketing professionals have long awaited specific direction from FDA on appropriate delivery of product information in social media outlets, new technology devices, and other Internet-based communication channels. One of the most critical issues we have faced in this new environment is how to handle off-label information where content is user-generated and cannot be controlled. This past December, FDA issued guidance covering some aspects of this situation.¹

Insights

The title of the document, “Responding to Unsolicited Requests for Off-label Information about Prescription Drugs and Medical Devices,” provides an indication of its limited scope: “Requests for off-label information” are a specific type of event that manufacturers have encountered prior to new Internet-based communications. The majority have established methods and channels in use to address these requests that align with federal regulations.

The new guidance does not provide recommendations that contradict or circumvent these existing regulations or methods/channels. Direction is provided for responding to non-public off-label information requests, but these recommendations are in line with responses to non-public information requests received through traditional channels. Recommendations for responses to public requests for information, however, are more critical, as these recommendations cover “third-party” properties, including social media outlets, housing user-generated content.

While the guidance provides predictable recommendations of how to respond to these public requests, the most important aspect of the document is the opportunity provided for manufacturers to “choose to respond” to requests of this nature. This implies that FDA does not expect manufacturers to respond to or participate in all “discussions” taking place on Internet-based venues mentioning their products and their potential off-label uses.

Implications

The relevance of the guidance document to our marketing colleagues follows its alignment with existing regulations: all responses to off-label information, public or non-public, are required to be handled by medical staff in a private fashion and in a non-promotional manner — not by marketing or sales professionals.

After reviewing the two FDA guidance documents covering pharmaceutical marketing in the environment of new technology and communication, we do not expect any future guidance documents to provide direction that contradicts existing guidelines, and a keen marketer will be able to infer FDA positions on issues not yet covered.