Abstract
This paper provides an overview of the General Accounting Offices (GAO’s) role with respect to the Food and Drug Administration (FDA) and the pharmaceutical industry. An independent, third-party study of off-label uses conducted by the GAO is discussed. The perspectives on off-label uses of FDA, the United States Congress, the pharmaceutical industry, and pharmacy benefit managers are presented. Questions to be pondered are highlighted.
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References
U.S. General Accounting Office. Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies. 1991, GAO/ PEMD-91-14.
Department of Health and Human Services, Office of Inspector General. Experiences of Health Maintenance Organizations with Pharmacy Benefit Management Companies. April 1997. OEI-01-95-00110.
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Hansen, J.C. Questions to Ponder Concerning Off-Label Uses. Ther Innov Regul Sci 32, 383–384 (1998). https://doi.org/10.1177/009286159803200209
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DOI: https://doi.org/10.1177/009286159803200209