Abstract：The US Orphan Drug Act (ODA) aims at promoting the development of orphan drugs that have limited commercial value,but this policy gives an enormous impetus to the US biopharmaceutical industry.In this article,firstly we introduce the background of ODA and its incentives,and then review its achievements.Based on the case study of the four most successful biotechnology companies,we analyze the influence of ODA on US biopharmaceutical industry.The results show that by the means of technology push and economy pull,ODA have not only stimulated the R&D and manufacture of orphan drugs but also played a positive role in propelling the development of US biopharmaceutical industry.
丁瑨. 罕用药政策对生物医药产业的影响——基于美国生物科技公司的案例研究[J]. 中国科技论坛, 2014(11): 90-96.
Ding Jin. The Impact of Orphan Drug Act on Biopharmaceutical Industry ——Case Study of US Biotechnology Companies. , 2014(11): 90-96.
[1]Rothaermel FT.Complementary Assets,Strategic Alliances,and the Incumbent's Advent:an Empirical Study of Industry and Firm Effects in the Biopharmaceutical Industry[J].Research Policy,2001,30(8):1235-1251. [2]Rohde DD.Orphan Drug Act:an Engine of Innovation? At What Cost?[J].Food and Drug Law Journal,2000,55:125-134. [3]Welllman-Labadie O,Zhou Y.The US Orphan Drug Act:Rare Disease Research Stimulator or Commercial Opportunity?[J].Health Policy,2010,95(2):216-228. [4]Pulsinelli GA.Orphan Drug Act:What's Right with It?[J].Santa Clara Computer High Technol Law Journal,1999,15(2):299-345. [5]Reaves ND.A Model of Effective Health Policy:the 1983 Orphan Drug Act[J].Journal of Health & Social Policy,2004,17(4):61-71. [6] Pariser A.Rare Disease Clinical Development at CDER[EB/OL].FDA,http://www.fda.gov/downloads/Drugs/NewsEvents/ UCM227865.pdf. [7]Meekings KN,Williams CS,et al.Orphan Drug Development:an Economically Viable Strategy for Biopharma R&D[J].Drug Discovery Today,2012,17(13-14):660-664. [8]Melnikova I.Rare Disease and Orphan Drug[J].Nature Review Drug Discovery,2012,11(4):267-268. [9]DiMasi JA,Grabowski HG.The Cost of Biopharmaceutical R&D:Is Biotech Different?[J].Managerial and Decision Economics,2007,28(4-5):469-479. [10]Paul SM,Mytelka DS,et al.How to Improve R&D Productivity:the Pharmaceutical Industry's Grand Challenge[J].Nature Review Drug Discovery,2010,9(3):203-214. [11]Grabowski HG,Vernon J.The Distribution of Sales Revenues from Pharmaceutical Innovation[J].Pharmacoeconomics,2000,18(1):21-32. [12]Gottlober P.The Orphan Drug Act:Implement and Impact.(2001-5).Department of Health and Human Services,http://oig.hhs.gov/oei/reports/oei-09-00-00380.pdf. [13]Haffner ME,Whitley J,et al.Two Decades of Orphan Product Development [J].Nature Review Drug Discovery,2002,1(10):821-825.
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