FDA plans to ease rules for reprinting off-label use info

The proposal would allow greater use of journal articles about off-label use of drugs and devices.

By Susan J. Landers, AMNews staff. March 17, 2008.

Washington -- Drug firms would have a more direct route to physicians when it comes to spreading the word about new research findings for off-label uses of drugs and devices, if a new Food and Drug Administration proposal is finalized.

The proposal, which was published in the Feb. 20 Federal Register, would allow pharmaceutical manufacturers to distribute reprints of journal articles that support a particular use of a drug or device that does not appear on its label.

The FDA's action would reinstate an earlier policy allowing the distribution of such information. But this time around, less agency oversight would be required in the process, and that change has sparked concern. Specifically, it would not require the agency to preview the material that is to be sent to physicians, nor does it require pharmaceutical companies to submit applications to gain approval for the new indication.

Meanwhile, the FDA also published a lengthy draft guidance for the pharmaceutical industry explaining "Good Reprint Practices." Among the requirements: Only reprints from peer-reviewed journals that have editorial boards staffed by experts would be allowed, and false or misleading information would not be allowed.

Off-label use of drugs and devices is a common practice in physicians' offices. A 2006 study in the Archives of Internal Medicine found that unapproved uses accounted for 21% of an estimated 725 million scripts written in 2001 for 160 frequently prescribed drugs. Given the continued growth of prescription medicines, those numbers likely have increased.