This paper provides an overview of the General Accounting Office's (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.
U.S. General Accounting Office.Off-Label Drags: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies. 1991, GAO/PEMD-91–14.
2.
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.
