Off-label drug use has been around for decades, and it is perfectly legal for physicians to prescribe a medication for a condition not described in the approved labeling if it seems reasonable or appropriate.
Determining the appropriateness of such prescribing can be difficult, however, as physicians are drowning in reports from laboratory studies and clinical trials, potentially dubious promotions from pharmaceutical companies, pressure from patient advocacy groups to provide more therapies for various conditions, and hurdles to reimbursement by insurance providers. Experts suggest that changes in regulations and reimbursement relating to off-label therapies may be needed to help physicians give each patient the best care possible in today's clinical environment.
Hampton T. Experts Weigh in on Promotion, Prescription of Off-label Drugs. JAMA. 2007;297(7):683–684. doi:10.1001/jama.297.7.683
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