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Medical News & Perspectives |

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

Mike Mitka
JAMA. 2008;299(15):1759-1761. doi:10.1001/jama.299.15.1759.
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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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Critics are worried that drug and device makers will exploit proposed federal guidelines to justify the dissemination of journal article reprints to promote off-label use of their products.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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