A series of studies conducted by the General Accounting Office in 1991-92 found that approximately half of the uses of anticancer chemotherapy drugs are for indication other than those reviewed by the Food and Drug Administration and referenced on the FDA-approved label. The “off-label” uses of approved drugs have been an important tool for advancing the treatment of cancer. Third-party payers, including Medicare, typically denied reimbursement for these unlabeled indications on the ground that such uses were experimental or investigational. ASCO's position states that third-party payers should be required to cover off-label indications for anti-cancer drugs if such indications are listed in the compendia or supported in peer-reviewed medical literature.
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