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FDA allows drug firms to distribute journal articles about unapproved uses

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b187 (Published 19 January 2009) Cite this as: BMJ 2009;338:b187
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration has published guidance that allows drug and device companies to use reprints of journal articles about off-label, or unapproved, uses of their products in promotions to doctors.

    By allowing distribution of peer reviewed but off-label studies, the FDA recognises that doctors use approved drugs and devices in unapproved situations. Once a drug or device has been approved doctors can use it as they choose.

    A section of the Food and Drug Modernization Act that regulates distribution of articles about unapproved uses expired in September 2006, and the FDA came up with new, more liberal regulations this month, just before President George Bush left office. Although doctors were …

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