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FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products

By Marcella Auerbach

The U.S. Food and Drug Administration (FDA) last Friday issued a draft guidance on “Good Reprint Practices” for regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Draft guidances are often put into final form with substantially the same wording.

“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 Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, 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The FDA’s “Good Reprint Practices” draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.

Publications that the medical community rely on should be independent. Accordingly, some of the principles include ensuring that 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.

Not surprisingly, the draft guidance also recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the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 further, (stating the obvious), that articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

Full post as published by Pharma 101 - Pharmaceutical Fraud on March 25, 2008 (boomark / email).