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54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

07. bis 10.09.2009, Essen

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Optimal Regulation of Off-label Drug Use

Meeting Abstract

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  • Stefan Felder - Universität Duisburg-Essen, Essen
  • Anja Olbrich - Otto-von-Guericke Universität, Magdeburg

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Essen, 07.-10.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gmds074

doi: 10.3205/09gmds074, urn:nbn:de:0183-09gmds0749

Published: September 2, 2009

© 2009 Felder et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Recent EU and US regulations offer an extension of patent duration if manufacturers invest in pediatric clinical tests in order to reduce the extent of off-label drug use. This paper shows that, instead, a reinforcement of physician liability for off-label use is the preferred instrument to achieve dynamic efficiency. Since patent prolongation has no effect on physicians’ prescription behavior, it may lead to biased investment decisions. By contrast, the liability threat reduces the demand for off-label use exactly where it is required, giving manufacturer an appropriate incentive to invest in an extended approval.