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来源类型Article
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Generics substitution, equivalence standards, and international oversight: Complex issues facing the FDA
Roger Bate; Aparna Mathur; Dinesh Thakur
发表日期2015-12-14
出版年2015
语种英语
摘要Abstract: The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch–Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process – there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. For subscribers to Trends in Pharmacological Sciences, the paper is available here.
主题Economics ; Public Economics
标签drug industry ; FDA ; generic drugs ; Pharmaceuticals
URLhttps://www.aei.org/articles/generics-substitution-equivalence-standards-and-international-oversight-complex-issues-facing-the-fda/
来源智库American Enterprise Institute (United States)
资源类型智库出版物
条目标识符http://119.78.100.153/handle/2XGU8XDN/259795
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Roger Bate,Aparna Mathur,Dinesh Thakur. Generics substitution, equivalence standards, and international oversight: Complex issues facing the FDA. 2015.
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