LIMITING OFF-LABEL INFORMATION
FDA provided some clues to how it will address industry use of "emerging electronic media" in a draft guidance published in
December 2011 on how drug, biotech, and device manufacturers should respond to unsolicited requests for off-label information.
The proposal deals with an issue raised in a citizen petition filed with FDA in July 2011 by pharmaceutical manufacturers
seeking clarification on several off-label communications topics. The petitioners sought advice on handling off-label information
when dealing with unsolicited requests for information, as well as during scientific exchange; when providing information
to formulary committees and payers; and in disseminating clinical-practice guidelines prepared by third parties.
This recent guidance from FDA, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, mentions social-media communications as part of its larger discussion of off-label communications. The main thrust of the
document is to clarify that manufacturers may provide information on off-label drug uses, but only in response to "unsolicited"
requests from individuals completely independent of the manufacturer; any hint that the company stimulated the request makes
it a solicited request, and potentially violative.
Here is where social media comes in: queries spurred by a company video posted on YouTube, for example, would shift the question
into the "solicited" category, which may be violative. Social media sites also are mentioned as possible forums for a company
to receive questions from the public, including those involving off-label drug uses.
Probably the most contentious item in the guidance is FDA's proposal that manufacturers handle requests for information made
in public or through the Internet in the same way as queries made by email or the phone: provide a response only to the individual
requester in "a private, one-on-one communication" and not communicate it online. The agency's concern is that a public response
exposes those not making the query to off-label information, and that such information could remain on a website after it
When receiving an unsolicited request on an issue related to off-label use, FDA advises manufacturers to provide contact information
to medical or scientific personnel (not salesmen) and direct the individual to follow up off-line. Such information should
be truthful, balanced, non-misleading and reflect an effort by the company to avoid promoting off-label drug uses. This approach
means, however, that a broad audience can see a query and any erroneous, independent statements it generates, but not the
Although the guidance disappointed those anticipating more specific advice on social-media communications, the document is
important because it includes new Internet technologies as part of the discussion on a critical off-label communications topic,
says Peter Pitts, president of the Center for Medicine in the Public Interest. Pitts notes that FDA acknowledges that Internet
sites can produce a good deal of misinformation, but the agency fails to explain how companies should deal with erroneous
statements about their products, in all media.