Communications Advances Present Challenges to Manufacturers - Social media use raises questions about applying old standards to new information technology. - BioPharm International

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Communications Advances Present Challenges to Manufacturers
Social media use raises questions about applying old standards to new information technology.


BioPharm International
Volume 25, Issue 3, pp. 14-17

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FDA provided some clues to how it will address industry use of "emerging electronic media" in a draft guidance published in December 2011 on how drug, biotech, and device manufacturers should respond to unsolicited requests for off-label information.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.


Regulatory Roundup
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 becomes outdated.

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 company's answer.

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.


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