The FDA has issued draft guidance on “Good reprint practices” for distribution of journal articles involving unapproved uses of FDA-approved drugs and medical devices.
A 60-day public comment period will precede finalization of the guidance, which aims to clarify the line between legitimate distribution of journal articles and off-label promotion.
“Articles that discuss unapproved uses of FDA-approved drugs and medical devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” allowed FDA deputy commissioner for policy, Randall Lutter, in a statement. “This guidance also safeguards against off-label promotion.”
Under the draft guidance, manufacturers are advised to ensure that articles they distribute are peer reviewed and published by an organization that has an editorial board, and that the publisher has fully disclosed any conflicts of interest or biases for all authors, contributors and editors associated; and that the article is peer reviewed. The guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product covered. Articles that are not supported by credible medical evidence will be considered false and misleading and should not be distributed, the guidance advises.
The agency reserves the right to determine whether distribution constitutes promotion of an unapproved “new use,” or whether it causes a product to be considered misbranded or adulterated under the Food Drug and Cosmetic Act.
Distribution of journal articles on unapproved uses of drugs was previously covered under Section 401 of the FDA Modernization Act, but that clause expired Sept. 30, 2006.
