New Rules Proposed for Use of Off-Label Drugs and Devices


The U.S. Food and Drug Administration (FDA) is revising, for the first time since 2009, its draft guidance on how to present and publish information about off-label use of a drug or device.

The FDA is recommending practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities “scientific and medical publications that discuss unapproved new uses of approved drugs or approved or cleared medical devices,” the FDA said in an advance copy of its Federal Register notice.

Bloomberg News reported that the guidance is that generally such publications are required to appear in journals, scientific or medical reference texts, and clinical practice guidelines. The draft guidance contains separate but related recommendations for those three types of publications.

The draft guidance recommends that the information have a “prominently displayed and permanently affixed statement that some of the uses for the drugs and/or devices being distributed might not have FDA approval or clearance.”

According to MedPage Today, a medical news website for health care professionals, the new rules would mean that information about off-label use must

be peer reviewed

be published by an organization that has an editorial board that includes an independent expert

be distributed with approved labeling

be distributed separately from promotional information

include opposing views—when available—regarding the unapproved use

present a reprint that is unabridged

The draft guidance on off-label use is open for public comment until May 2, 2014. Submit electronic comments to

Written comments may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

April 2014 (Vol. 6, Number 4)​