FDA Releases Draft Guidance on Dissemination of Reprints of Peer Reviewed Journal Article

Companies should consider filing written comments on the Draft Guidance; the deadline for comment submission will be approximately April 20, 2008.

On February 15, 2008, the U.S. Food and Drug Administration (FDA) issued a news release announcing the availability for public comment of a Draft Guidance on dissemination of reprints of peer reviewed medical journal articles and other information about unapproved uses of approved new drugs and approved or cleared medical devices. (See http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html; http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.) Such unapproved uses are generally referred to as "off-label" uses, because the FDA approved "label" defines and generally limits the scope of what can be communicated about an approved product by a regulated entity, such as a drug or device manufacturer, at least in a promotional context. Moreover, in assessing the Draft Guidance, it is important to observe that it does not purport to regulate the dissemination of any information by third parties, such as medical and scientific journals, which are truly independent of the drug or device manufacturer. Nor does the Draft Guidance in any way restrict the ability of a licensed practitioner to use an approved drug or device for any purpose, subject to whatever constraints might exist under applicable standards of medical practice.

The draft guidance"Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved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"evoked criticism even before it was issued. On November 30, 2007, Congressman Henry Waxman, Chairman of the U.S. House of Representatives Committee on Oversight and Government Reform, who had obtained an internal agency draft of the draft guidance, sent a letter to FDA Commissioner Andrew von Eschenbach objecting to its release. (http://oversight.house.gov/story.asp?ID=1641.) The letter suggested, among other things, that then-impending draft guidance was part of a concerted effort by the Bush administration to create a "large loophole" that would effectively allow pharmaceutical and device manufacturers to engage in widespread marketing and promotion of approved drugs for unapproved uses. A careful review of the draft guidance suggests, however, that it is a measuredperhaps even overly restrictiveresponse to the widely acknowledged public health need for...