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Mike Mitka

JAMA. 2008;299(15):1759-1761.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Proposed guidelines by the US Food and Drug Administration (FDA) addressing drug and device manufacturers' dissemination of journal article reprints that discuss off-label use of these products have come under fire.

Critics say the proposed guidance, as currently written, will allow companies to selectively use as a marketing tool peer-reviewed journal articles that support off-label use of their products. They also argue the guidelines could possibly harm public health by allowing manufacturers a back door for putting products into the health care setting for unapproved uses without having to conduct rigorous clinical studies to gain FDA approval.

The draft guidance, Good Reprint Practices, was issued February 15 with the FDA accepting comments through April 21 (http://www.fda.gov/oc/op/goodreprint.html). The FDA said the draft guidance represents its current thinking on the topic and may be modified based on the comments it receives.

Critics are worried that drug and . . . [Full Text of this Article]

OFF-LABEL USE



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