Questions to Ponder concerning Off-Label Uses

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.