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

Grabowski, Henry G

Kyle, Margaret

Mortimer, Richard

Long, Genia

Kirson, Noam

United States

2013-04-23T17:10:08Z

2011-11

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.

http://www.ncbi.nlm.nih.gov/pubmed/22068409

30/11/2157

1544-5208

https://hdl.handle.net/10161/6729

eng

Health Affairs (Project Hope)

Health Aff (Millwood)

10.1377/hlthaff.2010.0270

Drugs, Generic

Economic Competition

Legislation, Drug

Policy Making

United States

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

Journal article

http://www.ncbi.nlm.nih.gov/pubmed/22068409

2157

2166

11

Duke

Economics

Trinity College of Arts & Sciences

Published

30