The generic drug user fee amendments: an economic perspective

Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Adminis...

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Autores principales: Berndt, Ernst R, Conti, Rena M, Murphy, Stephen J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912081/
https://www.ncbi.nlm.nih.gov/pubmed/29707218
http://dx.doi.org/10.1093/jlb/lsy002
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author Berndt, Ernst R
Conti, Rena M
Murphy, Stephen J
author_facet Berndt, Ernst R
Conti, Rena M
Murphy, Stephen J
author_sort Berndt, Ernst R
collection PubMed
description Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes.
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spelling pubmed-59120812018-04-27 The generic drug user fee amendments: an economic perspective Berndt, Ernst R Conti, Rena M Murphy, Stephen J J Law Biosci Original Article Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. Oxford University Press 2018-04-11 /pmc/articles/PMC5912081/ /pubmed/29707218 http://dx.doi.org/10.1093/jlb/lsy002 Text en © The Author 2018. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Berndt, Ernst R
Conti, Rena M
Murphy, Stephen J
The generic drug user fee amendments: an economic perspective
title The generic drug user fee amendments: an economic perspective
title_full The generic drug user fee amendments: an economic perspective
title_fullStr The generic drug user fee amendments: an economic perspective
title_full_unstemmed The generic drug user fee amendments: an economic perspective
title_short The generic drug user fee amendments: an economic perspective
title_sort generic drug user fee amendments: an economic perspective
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912081/
https://www.ncbi.nlm.nih.gov/pubmed/29707218
http://dx.doi.org/10.1093/jlb/lsy002
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