On February 20, the Food & Drug Administration (FDA) proposed guidelines for manufacturers of drugs and devices who would like to distribute scientific and medical articles that discuss off-label uses of approved products. The draft guidance is entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The document proposes that distribution be limited to peer-reviewed scientific or medical articles that are published by an with an editorial board that has a policy of disclosure of conflicts of interest. The publication should not be written for, edited by, or funded by the manufacturer, and it cannot be false or misleading or pose a significant risk to public health. Letters to the editor, abstracts of a publication, reports of Phase 1 trials in healthy subjects, or reference publications that contain insufficient substantive discussion of the data would not be acceptable. The draft guidance also proposes guidelines on the manner in which companies should distribute scientific and medical information. For instance, a company should not abridge, highlight, or summarize the article. In addition, FDA would expect that the article be accompanied by numerous disclosures and addendums, including: the approved labeling of the drug or medical device; a comprehensive bibliography of related information; a disclosure about the unapproved use being discussed, a disclosure of the manufacturer’s interest in the product, a disclosure of any financial interest held by the author, and, a representative publication of any articles that call into question the conclusions of the article being disseminated. The journal article should also be distributed separately from promotional materials. Comments on the guidance are due April 21, 2008.  Reed Smith has prepared a bulletin analyzing the draft; the bulletin is available here.