Reps Can Distribute Info About Off-Label Drug and Device Use, Says the FDA

Michael O'Riordan

January 14, 2009

January 14, 2009 (Rockville, Maryland) — The Food and Drug Administration (FDA) has finalized guidelines that will allow pharmaceutical and device company reps to distribute journal articles to doctors about off-label uses of their products. The new recommendations are a finalized version of the draft about "good reprint practices" first issued in February 2008.

The guidelines contain conditions, however, most notably that the reps are not allowed to discuss the journal article with the physician during the sales visit. The article must also be published by an organization that has an editorial board that uses experts in the subject under review and not be in the form of a special supplement funded by the manufacturers.

In addition, the information must be unabridged and not manipulated by the manufacturer in any way. Moreover, the reprints must contain a "prominently displayed and permanently affixed statement" noting the uses discussed are not approved by the FDA.

In the guidance document, the agency states that it recognizes that "public health can be served when healthcare professionals receive truthful and nonmisleading scientific and medical information on unapproved uses of approved or cleared medical products."

The FDA states that the reprint, article, or reference publication should not be false or misleading and not pose a significant risk to public health if relied upon. Excluded from distribution are letters to the editor, journal abstracts, and reports of phase 1 trials in healthy subjects.

Last February, when the guidance document was proposed, it drew criticism from opponents who said it allowed companies to promote products that had not been adequately tested. In Washington, DC, Rep Henry Waxman (D-CA), said that the decision "fundamentally undermines the requirement that companies prove to the FDA that each new use is safe and effective."

The distribution of journal articles about the off-label use of drugs had been allowed previously, although the legal provision expired in 2006.

  1. Food and Drug Administration. Guidance for industry: 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 US. January 2009. Available at: http://www.fda.gov/oc/op/goodreprint.html.



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