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Lost medicines: a longer view of the pharmaceutical industry with the potential to reinvigorate discovery.
Drug Discovery Today ( IF 7.4 ) Pub Date : 2018-09-14 , DOI: 10.1016/j.drudis.2018.09.006
Michael S Kinch 1 , Grant A Kinch 1 , Rebekah H Griesenauer 1
Affiliation  

It is widely understood that the 1962 Kefauver-Harris Amendment to the Food, Drug and Cosmetics Act ushered in the modern regulation of medicines requiring a combination of safety and efficacy. However, fewer appreciate the amendment was applied retroactively to virtually all medicines sold in the USA. For various reasons, many medicines faded into history. Here, we identify and analyze >1600 medicines (including over-the-counter drugs) and their innovators prior to the enactment of Kefauver-Harris. We report 880 of these past medicines are no longer accessible. This project also reveals new insight into the pharmaceutical enterprise, which reveals an industry already mature and beginning to retract before enactment of the legislation. Beyond its historical implications, the recollection of these medicines could offer potential starting points for the future development of much-needed drugs.

中文翻译:

药品遗失:对制药业有更长远的了解,有可能重振发现。

众所周知,1962年《食品,药品和化妆品法》的《修正案》(Kefauver-Harris Amendment)引入了对安全性和功效相结合的现代药物法规。但是,很少有人意识到该修正案追溯适用于几乎所有在美国销售的药品。由于各种原因,许多药物逐渐淡入历史。在此,我们在Kefauver-Harris颁布之前,识别并分析了1600多种药物(包括非处方药)及其创新者。我们报告880种这些过去的药物不再可用。该项目还揭示了对制药企业的新见解,揭示了一个已经成熟并在立法颁布之前就开始退出的行业。除了其历史意义之外,
更新日期:2018-09-14
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