Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
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.
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Journal articlePermalink
https://hdl.handle.net/10161/6729Published Version (Please cite this version)
10.1377/hlthaff.2010.0270Publication 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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Show full item recordScholars@Duke
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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