Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
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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.
Published Version (Please cite this version)10.1377/hlthaff.2010.0270
Publication InfoGrabowski, 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.
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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 been publishing research papers for over four decades, from his earlier work, “The Effects of Regulatory Policy on the Incentives