Nightingale S L, Morrison J C
JAMA. 1987 Sep 4;258(9):1200-4.
While generic substitution is not a new phenomenon, a number of factors have combined to markedly increase generic drug use. The most important factor is a 1984 law, the Drug Price Competition and Patent Term Restoration Act, which facilitates the entry into the marketplace of generic versions of brand name drugs. This law and Food and Drug Administration (FDA) policies are designed to approve for marketing generic drug products that are therapeutically equivalent to their brand name counterparts. With increased availability of generic drugs, physicians have expressed the need for more information about the FDA process for determining that generic versions of brand name drug products are both safe and effective and that generic drug products will produce the same therapeutic results as those achieved by the brand name products. This article describes FDA procedures for approving generic drug products and examines issues important to the prescribing physician, in particular, therapeutic equivalence. The article also describes the role of the states in generic substitution and the availability of information from the FDA on the therapeutic equivalence of drug products.
虽然非专利药替代并非新现象，但多种因素共同作用，显著增加了非专利药的使用。最重要的因素是1984年的一项法律，即《药品价格竞争与专利期限恢复法案》，该法案促进了品牌药非专利版本进入市场。这项法律以及食品药品监督管理局（FDA）的政策旨在批准销售在治疗上等同于其品牌对应产品的非专利药品。随着非专利药的可获得性增加，医生表示需要更多关于FDA确定品牌药产品的非专利版本既安全又有效的过程的信息，以及非专利药品将产生与品牌产品相同治疗效果的信息。本文描述了FDA批准非专利药品的程序，并探讨了对开处方医生重要的问题，特别是治疗等效性。文章还描述了各州在非专利药替代中的作用以及FDA关于药品治疗等效性信息的可获得性。
