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Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.

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Date
2011-11
Authors
Grabowski, Henry G
Kyle, Margaret
Mortimer, Richard
Long, Genia
Kirson, Noam
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432
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Abstract
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.
Type
Journal article
Subject
Drugs, Generic
Economic Competition
Legislation, Drug
Policy Making
United States
Permalink
https://hdl.handle.net/10161/6729
Published Version (Please cite this version)
10.1377/hlthaff.2010.0270
Publication Info
Grabowski, Henry G; Kyle, Margaret; Mortimer, Richard; Long, Genia; & Kirson, Noam (2011). Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act. Health Aff (Millwood), 30(11). pp. 2157-2166. 10.1377/hlthaff.2010.0270. Retrieved from https://hdl.handle.net/10161/6729.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Grabowski

Henry G. Grabowski

Professor Emeritus of Economics
Professor Grabowski specializes in the investigation of economics in the pharmaceutical industry, government regulation of business, and the economics of innovation. His specific interests within these fields include intellectual property and generic competition issues, the effects of government policy actions, and the costs and returns to pharmaceutical R&D. He has over one hundred peer reviewed articles analyzing the economics of pharmaceuticals and also several books and monograph publica
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