FDA Proposes Revised Guidance on Communicating Off-Label Drug Uses

Published Online: Thursday, April 10, 2014
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The FDA has released a draft guidance specifying what sort of information drug makers can distribute to physicians regarding off-label uses of drugs that are already on the market. If adopted, the draft guidance will update a 2009 guidance criticized as overly restrictive by drug manufacturers.

According to the draft guidance, drug manufacturers would be able to distribute information on unapproved uses provided that it is published by an organization with an editorial board including those with expertise on the subject covered; is peer-reviewed; is in the form of an unabridged reprint or copy of the article; is distributed with approved labeling; includes opposing views, when available, regarding the unapproved use, particularly if the findings in the article being distributed have been called into question; and is distributed separately from promotional information.

In addition, the manufacturer must make clear, with “a prominently displayed and permanently affixed statement,” that the uses in question aren’t approved by the FDA. The draft guidance specifically bans from distribution letters to the editor, study abstracts, reports of healthy volunteer studies, and publications including statements or conclusions in the absence of substantive discussion of the investigation or data on which they are based. Comments on the draft guidance are due by May 2.

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