Who Certifies Off-Label?

Abstract

Off-label prescribing of pharmaceuticals provides a window onto how a less-regulated drug certification system would operate because such prescribing is permitted without extensive efficacy testing by the Food and Drug Administration. The experience with off-label prescribing and the experience of pre-1962 America suggest that initial efficacy requirements may do more harm than good because they slow or altogether stop various drugs' entry into the market. Dropping efficacy requirements is a proposal that should be taken seriously.

Keywords: Off-label, prescription drugs, FDA, efficacy, Food and Drug Administration, off-label prescribing, drug safety, prescription

JEL Classification: O31, O32, O38, I18, I17