The FDA recommended new guidelines that would let medical-device manufacturers distribute medical-journal articles that reference unapproved, or off-label, uses of FDA-approved drugs and medical devices to doctors. “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,” says Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”

Previously, Section 401 of the FDA Modernization Act set out guidelines that allowed disseminating information on unapproved uses of FDA-approved products as long as reprints were given to the FDA beforehand and they promised to seek approval from the agency of the use discussed. As long as manufacturers met the guidelines, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an off-label use. However, Section 401 expired on Sept. 30, 2006.

The FDA's “Good Reprint Practices” draft guidance recommends a few principles that manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.

The principles include ensuring the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors, or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.

In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

Read the entire guidance at www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html