Who Certifies Off-Label?

4 Pages Posted: 25 Jul 2004

See all articles by Daniel B. Klein

Daniel B. Klein

George Mason University - Department of Economics; George Mason University - Mercatus Center

Alexander T. Tabarrok

George Mason University - Department of Economics; Mercatus Center

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 B. Klein (Contact Author)

George Mason University - Department of Economics ( email )

4400 University Drive
Fairfax, VA 22030
United States

HOME PAGE: http://economics.gmu.edu/people/dklein

George Mason University - Mercatus Center ( email )

3434 Washington Blvd., 4th Floor
Arlington, VA 22201
United States

Alexander T. Tabarrok

George Mason University - Department of Economics ( email )

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

Mercatus Center ( email )

3434 Washington Blvd., 4th Floor
Arlington, VA 22201
United States

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