On January 12, 2009, the Food and Drug Administration (FDA) published a Guidance document, 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 (the "Good Reprint Practices Guidance"). The Good Reprint Practices Guidance largely adopts the substance and tone included in the draft guidance that the FDA published in February 2008 and for which it solicited public comment, see, http://www.saul.com/common/publications/pdf_1547.pdf
The Good Reprint Practices Guidance is the first formal pronouncement of the FDA's position relating to the dissemination of off-label information since the sunset on September 30, 2006 of the provisions in the Food and Drug Administration Modernization Act that govern the dissemination of enduring materials. While the Good Reprint Practices Guidance does not have the force of law, it does provide the FDA's current thinking on this topic. Of course, the administration of President-elect Obama may see fit to change the Good Reprint Practices Guidance--which facilitates the dissemination of truthful, non-misleading scientific literature regarding unapproved uses--but the FDA may find it difficult to put the genie back in the bottle.
Like its draft predecessor, the Good Reprint Practices Guidance describes the types of reprints, articles and reference publications that should and should not be distributed to interested parties, and manner in which such information should be disseminated. The Good Reprint Practices Guidance provides several examples of what constitutes a scientifically sound article or reference publication, clarifies what constitutes false or misleading information, and provides more specific instructions to ensure transparency of the financial interest that an author may have with the product manufacturer.
Companies should review the Good Reprint Practices Guidance and consider updating or implementing their policies to stay aligned with the FDA's suggestions.
Go to http://www.fda.gov/oc/op/goodreprint.html to see the Good Reprint Practices Guidance.
For more information, please contact either of the authors of this Alert.
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