Off-Label Promotion Targeted in FDA Information Guidelines

February 18, 2008

The U.S. Food and Drug Administration had issued a draft of its "Good Reprint Practices" guidelines for drug manufacturers when they are distributing articles involving "off-label" use of drugs and devices to scientific and medical journals or other reference publications.

MONDAY, Feb. 18 (HealthDay News) -- The U.S. Food and Drug Administration had issued a draft of its "Good Reprint Practices" guidelines for drug manufacturers when they are distributing articles involving "off-label" use of drugs and devices to scientific and medical journals or other reference publications.

The guidelines, aimed at preventing manufacturers from off-label promotion, cover a range of principles. Target publications should have an editorial board, should have full disclosure of conflict of interest policies, and should publish peer-reviewed articles published according to specific procedures. The guidelines recommend false and misleading articles should not be distributed and also cover special supplements with a recommendation against their distribution, as well as distribution of industry-funded publications where the manufacturer of the product in question funds the publication.

The draft guidelines, which replace Section 401 of the Food and Drug Administration Modernization Act guidelines which expired on Sept. 30, 2006, are open to public comment until April 15.

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said the FDA's deputy commissioner for policy, Randall Lutter, Ph.D. "This guidance also safeguards against off-label promotion."

More Information

Copyright © 2008 ScoutNews, LLC. All rights reserved.