The FDA has released a draft guidance titled ”Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of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.”

Under the draft guidance, such articles must be published by an organization with an editorial board consisting of experts in the subject area, and the articles must be peer-reviewed. The draft guidance also prohibits distribution of special supplements or publications funded by any of the manufacturers of a product mentioned in the publication. Further, if the conclusion of the article or text has been specifically called into question by another article, the material must be distributed with the article that reached the contrary conclusion.

FDA criteria for the distribution of peer-reviewed articles in medical journals include:

• Articles are not written, edited, or published for, or at the request of a drug or device manufacturer.

• Scientific information is distributed in an unabridged reprint or copy without any markings, highlighting, or characterization of the information.

• Reprints must be accompanied by a comprehensive bibliography.

• No promotional materials are attached to the reprint.

The draft guidance does not apply to letters to the editors, abstracts, and reports of phase 1 clinical trials.