Munos Bernard
Lilly Corporate Center, Indianapolis, Indiana 46285, USA.
Nat Rev Drug Discov. 2009 Dec;8(12):959-68. doi: 10.1038/nrd2961.
Despite unprecedented investment in pharmaceutical research and development (R&D), the number of new drugs approved by the US Food and Drug Administration (FDA) remains low. To help understand this conundrum, this article investigates the record of pharmaceutical innovation by analysing data on the companies that introduced the approximately 1,200 new drugs that have been approved by the FDA since 1950. This analysis shows that the new-drug output from pharmaceutical companies in this period has essentially been constant, and remains so despite the attempts to increase it. This suggests that, contrary to common perception, the new-drug output is not depressed, but may simply reflect the limitations of the current R&D model. The implications of these findings and options to achieve sustainability for the pharmaceutical industry are discussed.
尽管在制药研发（R&D）方面进行了前所未有的投资，但美国食品药品监督管理局（FDA）批准的新药数量仍然很少。为了帮助理解这一难题，本文通过分析自1950年以来推出了约1200种已获FDA批准新药的公司的数据，来研究制药创新的记录。该分析表明，这一时期制药公司的新药产出基本保持不变，尽管有增加新药产出的尝试，但目前依然如此。这表明，与普遍看法相反，新药产出并非受到抑制，而可能只是反映了当前研发模式的局限性。本文还讨论了这些发现的意义以及制药行业实现可持续发展的选择。
