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

UNLABELLED: 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. ABBREVIATIONS: : AANS, American Association of Neurological SurgeonsACDF, anterior cervical discectomy and fusionACF, anterior cervical fusionBMP, bone morphogenetic proteinCNS, Congress of Neurological SurgeonsDJDD, degenerative joint and disc diseaseFDA, US Food and Drug Administration.