FDA offers healthcare industry guidance on unsolicited requests

The FDA released its draft "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices."

Late last year, the FDA released its draft “Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” This is the first of multiple planned draft guidances responding to testimony and comments from 2009 hearings addressing social media marketing by manufacturers and distributors of prescription drug products and medical devices. 

This first draft guidance recommends how companies should respond to unsolicited requests for off-label information about their drugs and devices, including requests received through social media. The draft guidance limits its recommendations to unsolicited requests, which are non-public, or public requests initiated by persons or entities that are completely independent of the relevant companies, such as requests made by healthcare professionals, academics, patients, and caregivers, about off-label information. These unsolicited requests exclude information about approved or cleared indications or conditions of use for drugs and devices.

Requests for off-label information prompted in any way by a company or its representatives are solicited requests outside the scope of this draft guidance. The FDA's draft guidance generally advises that companies may respond to unsolicited requests for off-label information about drugs and devices by providing “truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request.” The draft guidance also allows companies to provide specific examples and direction depending on whether the request was made publicly or privately.

Non-public unsolicited requests

Non-public unsolicited requests for off-label information may be received by mail, e-mail, telephone, or through a firm-controlled website (for example, an individual making a request directly to the company as a private, one-on-one communication). The FDA recommends that a company's response to a non-public unsolicited request should be provided only to the individual making the request and information distributed in response to an unsolicited request should be tailored to answer only the specific question or questions asked.

Public unsolicited requests

Public unsolicited requests for off-label information may be received through a company's websites, discussion boards, chat rooms, or other public electronic forums maintained by or under the control of the company (for example, an individual posting a question on a company's Facebook page). A company might also encounter public requests for off-label information on third-party sites, including where questions are directed to website users at large.

In situations involving public requests, the FDA's draft guidance includes the following six recommendations:

• A company should respond only when the request pertains specifically to its own named drug or device (and is not solely about a competitor's drug or device).

• Information about a company's named drug or device should be limited to providing the company's contact information and should not include any off-label information.

• A response should convey that the question pertains to an unapproved or uncleared use of the drug or device and state that individuals can contact the medical or scientific representative or medical affairs department with the specific unsolicited request to obtain more information.

• Representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a particular company.

• A response should include a mechanism for providing readily accessible current FDA-required labeling, if any, for the product.

• A response should not provide any promotional information.

The draft guidance is not as expansive as the healthcare marketing industry had anticipated and many questions still remain. Nonetheless, the draft guidance provides a helpful framework for companies to follow when responding to unsolicited requests for off-label information, especially when received through social media channels. 

Manufacturers and distributors of prescription drug products and medical devices (and the marketing communications agencies representing them) should familiarize themselves with the FDA's draft guidance to ensure their responses to unsolicited requests for off-label information are in line with the FDA's recommendations and examples. This will ensure that the company's responses do not convey a company's intent that a drug or device be used for a new unapproved or unclear use. 

Companies should watch out for further updates as this draft guidance is finalized and the related draft guidances addressing social media marketing for the healthcare industry are released.

Michael Lasky is a senior partner at the law firm of Davis & Gilbert LLP, where he heads the PR practice group and co-chairs the litigation department. He can be reached at mlasky@dglaw.com.

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