Regulating Off-Label Drug Use — Rethinking the Role of the FDA

Abstract

The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers' promotion of drugs through the distribution of journal articles suggest that the FDA is moving toward an even more minimal role.¹