Download this Paper Open PDF in Browser

Who Certifies Off-Label?

4 Pages Posted: 25 Jul 2004  

Daniel B. Klein

George Mason University - Department of Economics

Alexander T. Tabarrok

George Mason University - Department of Economics

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

Suggested Citation

Klein, Daniel B. and Tabarrok, Alexander T., Who Certifies Off-Label?. Regulation, Vol. 27, No. 2, pp. 60-63, Summer 2004. Available at SSRN: https://ssrn.com/abstract=568402

Daniel Klein (Contact Author)

George Mason University - Department of Economics ( email )

4400 University Drive
Fairfax, VA 22030
United States

Alexander Tabarrok

George Mason University - Department of Economics ( email )

MSN 1D3
4400 University Drive
Fairfax, VA 22030
United States
703-993-2314 (Phone)

Paper statistics

Downloads
177
Rank
145,959
Abstract Views
1,328