Protect Pharmaceutical Innovation

摘要: In her Policy Forum “Fixing the legal framework for pharmaceutical research” (26 February, p. [1083][1], published online 11 February), GlaxoSmithKline attorney S. M. Knowles contends that Hatch-Waxman Act should be altered to increase data exclusivity from 5 14 years. If implemented, this disturbing change would likely narrow drug development pipeline and certainly prices. Knowles reports average R&D costs per in 2008 $1.2 billion. However, when analysis accounts tax deductions given industry removes opportunity expenses column, results show an estimate of one-seventh cost (including failures) ([ 1 ][2]) Knowles' industry-funded analysis. claims inadequate patent system does not allow recovery, yet companies have garnered three times profit Fortune 500 company over past decade 2 ][3]). also suggests federal government pay use innovator safety efficacy by generic competitors, but she fails acknowledge worldwide, nonprofits already fund majority health generates these discoveries 3 ][4]). Since its inception 1984, has saved U.S. $734 billion providing effective conduit lower-priced, pharmacotherapies come market. Generic drugs now make up 70% prescriptions dispensed account only 20% dollars spent on medications United States 4 ][5]). been preserving precarious balance between public welfare incentive innovation affordable medicines. We agree with one point: requires reform widen pipeline. Congress must ban brand-name firms' unethical “pay-for-delay” agreements competitors. doing so, it create a paradigm shift, disincentivizing compensatory and, instead, refocusing constructing novel therapies may address presently unmet medical needs. 1. [↵][6] 1. B. Young, 2. Surrusco , “Rx myths: The case against industry's ‘scare card,’” Public Citizen (July 2001). 2. [↵][7] Henry J. Kaiser Family Foundation, “Profitability manufacturers” (16 September 2009). 3. [↵][8] Global Health Research, “Monitoring financial flows (2006). 4. [↵][9] A. Engelberg et al ., N. Engl. Med. 361, 1917 (2009). [OpenUrl][10][FREE Full Text][11] [1]: /lookup/doi/10.1126/science.1184188 [2]: #ref-1 [3]: #ref-2 [4]: #ref-3 [5]: #ref-4 [6]: #xref-ref-1-1 "View reference text" [7]: #xref-ref-2-1 [8]: #xref-ref-3-1 [9]: #xref-ref-4-1 [10]: {openurl}?query=rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMp0908496%26rft_id%253Dinfo%253Apmid%252F19828525%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [11]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoibmVqbSI7czo1OiJyZXNpZCI7czoxMToiMzYxLzIwLzE5MTciO3M6NDoiYXRvbSI7czoyNToiL3NjaS8zMjgvNTk4NC8xMzU0LjEuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9