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Medical News & Perspectives
April 16, 2008

Critics Say FDA’s Off-Label Guidance Allows Marketing Disguised as Science

JAMA. 2008;299(15):1759-1761. doi:10.1001/jama.299.15.1759

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.

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