Off-label use of drugs and devices: Role of medical professionals in the establishment of parameters for their use

Donlin Long, Clark Watts

Research output: Contribution to journalArticle

Abstract

Physicians may use approved drugs and devices in ways not approved by the US Food and Drug Administration, a process termed off-label use. Often, because there is not suitable data defining safety and efficacy, the results of such use may become problematic, as occurred with the off-label use by spine surgeons of bone morphogenetic proteins in anterior cervical fusions. Using this undesirable history of bone morphogenetic proteins, and the historical record of the introduction of another drug, chymopapain, a method is developed and presented whereby such drugs or devices in the future may be studied by the professional medical specialties themselves outside the New Drug Application process, but with appropriate input from government and industry.

Original languageEnglish (US)
Pages (from-to)1014-1020
Number of pages7
JournalNeurosurgery
Volume72
Issue number6
DOIs
StatePublished - Jun 1 2013

Keywords

  • Bone morphogenetic protein
  • Drugs and devices
  • Off-label use
  • Professional specialties

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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