FDA may allow drug and device companies to promote “off-label” uses

BMJ 2007; 335 doi: (Published 13 December 2007) Cite this as: BMJ 2007;335:1229
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration (FDA) is proposing that drug and device companies can send doctors journal articles and reference materials about “off-label” or unapproved uses.

    Representative Henry Waxman, the California Democrat who chairs the House of Representatives’ Committee on Oversight and Government Reform, has strongly criticised the FDA’s proposal and has posted the FDA’s draft “Guidance for Industry” document on his website together with a letter that he has sent to Dr Andrew von Eschenbach, the FDA commissioner.

    “Until the Bush administration, these risks of permitting dissemination of journal articles on off-label uses were recognized by the FDA,” which had expressed “grave concerns” about the practice, he wrote.

    The draft guidelines “would carve a large loophole in the …

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