FDA draft guidance on article reprints for drugs/devices

The FDA today released a draft guidance document on the issue of the dissemination of medical literature about off label uses of drugs and devices.  You can find the FDA statement here, and the draft guidance here.  The public comment period ends, and you may start the process of commenting by clicking here. 

Henry Waxman, late of Roger Clemens bashing and Brian McNamee annointing, has previously been critical of this anticipated draft guidance (See Rep. Waxman's web site here) and we can expect more criticism.

What does the guidance say?  First, it covers drugs, devices and biologics.  The agency expresses the public health benefit  of dissemination of medical literature to the medical community.   A countervailing consideration is that inappropriate promotion of a drug/device for an unapproved purpose makes the device adulterated and misbranded. 

How do you strike the balance?  Physicians are free to use approved devices in accord with their judgment (subject of course to good and accepted medical practice) and they may write in the medical literature about their experience.  If a manufacturer is going to disseminate literature that is 'off label' the agency recommends best practices, some of which are highlighted  below:

• independent editorial board of recognized journal that is generally available
• peer review
• not in a publication funded in whole or in part by industry, or edited in whole or in part by industry
• not edited or significantly influenced by manufacturer financial interests
• entire unedited, unmarked up article to be provided
• must be accompanied by approved labeling
• comprehensive bibliography and contrary articles to be provided
• must clearly state that the use is an off label use.