Off-label information guidelines for comment

The US Food and Drug Administration (FDA) has issued draft guidelines that would permit device and drug manufacturers to provide information on off-label uses, but only if the request for information is unsolicited, reports Medscape News. An unsolicited request is one not initiated in any form by the drug or device maker or distributor itself.

Medscape explains that as a rule, manufacturers and distributors cannot promote a drug or medical device for uses other than those approved by FDA. But once given the FDA seal of approval, products can be used by healthcare professionals for purposes that are not included in the product's approved labelling or statement of intended uses. These off-label uses or treatment regimens, says FDA, "may be important therapeutic options and may even constitute a medically recognised standard of care."

The draft guidance covers nonpublic and public unsolicited requests. This latter category of request has proliferated in recent years because of the communication revolution brought about by the Internet. But as consumers move increasingly online for answers to their medical questions, they do not always access sites and electronic forums controlled by manufacturers and distributors, which the FDA says it trusts to respond in "a truthful, non-misleading, and accurate manner."

Instead, consumers sometimes access websites, discussion boards and chat rooms that are created and maintained by people other than the manufacturer or intellectual property owner who do not always publish online content that is accurate.

In response to both types of requests for off-label information the FDA has set out a separate list of recommendations. To see the full list of recommendations click here