Healthy Skepticism Library item: 14942

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Tanne JH.
FDA allows drug firms to distribute journal articles about unapproved uses.
BMJ. 2009 Jan 19; 338:b187:
http://www.bmj.com/cgi/content/extract/338/jan19_2/b187?papetoc

Abstract:

The US Food and Drug Administration has published guidance that allows drug and device companies to use reprints of journal articles about off-label, or unapproved, uses of their products in promotions to doctors.

By allowing distribution of peer reviewed but off-label studies, the FDA recognises that doctors use approved drugs and devices in unapproved situations. Once a drug or device has been approved doctors can use it as they choose.

A section of the Food and Drug Modernization Act that regulates distribution of articles about unapproved uses expired in September 2006, and the FDA came up with new, more liberal regulations this month, just before President George Bush left office. Although doctors were using drugs or devices off label (particularly to treat cancer), under the old rules companies were not allowed to promote these uses. The new guideline was published in the Federal Register on 13 January.

In its statement, . . .