FDA finalizes guidance on reprints

February 6, 2009

Pharmaceutical and medical device manufacturers received some guidance on when they can distribute scientifically valid journal articles detailing off-label uses of their products.

The FDA’s 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 U.S. eases restrictions on the distribution of articles from peer-reviewed medical and scientific journals.

Healthcare professionals can use products in any way they believe will benefit patients; however pharmaceutical and medical device manufacturers are not permitted to promote off-label uses.

A scientific or medical journal article that is distributed should:

  • Be published by an organization with an editorial board that uses independent experts and has a public policy of full disclosure of any conflict of interest or biases
  • Be peer-reviewed and published in accordance with the organization’s peer-review procedures
  • Not be in the form of a special supplement or publication funded in whole or in part by the manufacturer
  • Be generally available in bookstores or other independent distribution channels

A scientific or medical reference publication that is distributed should not be:

  • Written, edited, excerpted, or published specifically for, or at the request of, a pharmaceutical or medical device manufacturer
  • Edited or significantly influenced by a pharmaceutical or medical device manufacturer or any individuals having a financial relationship with the manufacturer

Source: FDA HcPRO