Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? A Critical Analysis of Physicians' Argumentation for Initial Efficacy Requirements.

The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses (“on-label”), but does not require certification before physicians may prescribe the drug for subsequent uses (“off-label”). Does it make sense to require FDA efficacy certification for new drugs but n...

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Bibliographic Details

Published in:	American Journal of Economics & Sociology Vol. 67; no. 5; pp. 743 - 776
Main Authors:	Klein, Daniel B., Tabarrok, Alexander
Format:	Article
Published:	Wiley-Blackwell November 2008
Subjects:	United States. Food & Drug Administration Physicians Clinical drug trials United States
Online Access:	View this record in EBSCOhost