FDA issues draft guidance for distributing information on unapproved medical product uses

Some principles in the guidance include ensuring articles are published by an organization with an editorial board and that possible conflicts of interest are fully disclosed.

The U.S. Food and Drug Administration has issued draft guidance on the distribution of medical or scientific journal articles and other reference publications that deal with unapproved uses of FDA-approved drugs and medical devices, the agency announced in a press release.

The draft guidance, "Good Reprint Practices," recommends principles that manufacturers should follow when distributing scientific or medical journal reprints, articles or reference publications, according to the release.

"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," Randall Lutter, FDA deputy commissioner for policy, stated in the release. However, the FDA's draft guidance also safeguards against off-label promotion, he noted.

Previously, Section 401 of the Food and Drug Administration Modernization Act included guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as manufacturers adhered to the guidelines, the FDA did not view the dissemination of such materials as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Some of the principles contained in the new draft guidance include ensuring that the article or reference material is published by an organization that has an editorial board.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. Additionally, the articles should be peer-reviewed and published in accordance with specific procedures, according to the release.

The draft guidance recommends against distributing special supplements or publications that were funded by one or more of the manufacturers of the product discussed in the article. Also, articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated.

The agency is accepting public comments regarding the draft guidance until April 21.