Unlabeled (also called off-label) uses are defined as the use of a drug product for indications or in patient populations, doses, or routes of administration that are not included in Food and Drug Administration (FDA)-approved labeling. The prevalence and clinical importance of prescribing FDA-approved drugs for unlabeled uses is substantial. In this report, the American Medical Association's (AMA) Council on Scientific Affairs reviews and makes recommendations on four important subjects related to unlabeled uses: clinical significance and prescribing; coverage and reimbursement; dissemination of information by pharmaceutical manufacturers; and improving the Supplemental New-Drug Application (SNDA) process. The recommendations in this report have been adopted as official policy of the AMA.
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Statement of SchultzWilliam B., Deputy Commissioner for Policy, FDA, before the Committee on Labor and Human Resources, U.S. Senate, February 22, 1996.
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American Medical Association.Drug Evaluations Annual, 1995. Chicago: American Medical Association; 1995.
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Statement of Michael Friedman, MD, Deputy Commissioner for Operations, FDA, before the Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Reform and Oversight, U.S. House of Representatives, September 12, 1996.
19.
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Statement of Carolyn Runowicz, MD, representing the American Society of Clinical Oncology and the Society of Gynecologic Oncologists, before the Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Reform and Oversight, U.S. House of Representatives, September 12, 1996.
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WinkerMA. The FDA's decisions regarding new indications for approved drugs: where's the evidence?JAMA1996;276:1342–1343. Editorial.
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32.
Food and Drug Administration.Fourth Annual Performance Report: Prescription Drug User Fee Act of 1992. Fiscal Year 1996 Report to Congress. December 19, 1996.
33.
Statement of JaggerSarah F., Director of Health Services Quality and Public Health Issues, Health, Education, and Human Services Division, U.S. General Accounting Office, before the Subcommittee on Human Resources and Intergovernmental Relations, Committee on Government Reform and Oversight, U.S. House of Representatives, September 12, 1996.
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