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FDA provided some clues to how it will address industry use of "emerging electronic media" in a draft guidance published in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
becomes outdated.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, nonmisleading and reflect an effort by the company to avoid promoting off-label
drug uses. This 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.
More thorny issues
These limits on Internet and social-media communications raises concerns about broader curbs on industry use of modern communications
technology for a broad range of corporate and operational functions, such as reporting corporate news and developments, recruiting
patients for clinical trials, or operating hotlines to receive consumer questions and comments.
Social media appears to have great potential for expanding public reporting of adverse drug events, for example. FDA posts
online forms for collecting adverse events under its MedWatch program, but the form is long, detailed, and not widely used.
Because consumers already turn to social media to discuss experiences with drugs and biotech therapies, as noted in the Pew
study, there's interest in imbedding an adverse event reporting "widget" into social media sites to encourage wider public
reporting of drug use problems.
Manufacturers are leery of such initiatives, because they would have to scour Twitter and Facebook and other sites to identify
such reports and respond to them, which could be a monumental task. Even with a common format, many publicly reported adverse
events would be useless if they fail to clearly identify the patient, reporter, dosage, and type of event. Furthermore, as
noted above, a pharmaceutical company still would be constrained in addressing misleading adverse-event reports, especially
those involving off-label use.
FDA has a Facebook page and uses Twitter to discuss product approvals. Regulators and manufacturers use blogs and social media
to alert the public to recalls and safety issues. As these activities expand, industry needs a way to ensure the accuracy
of information posted online about company operations and products, and to correct misleading or fraudulent postings.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, firstname.lastname@example.org