Unit 14Text B 注释及译文.docVIP

Text B How Does FDA Approve New Drugs? Under current law, all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. But it’s important to realize that no drug is absolutely safe. There is always some risk of an adverse reaction. It’s when the benefits outweigh the risks that FDA considers a drug safe enough to approve. outweigh [autˊwe?] vt. 在重量上超过；在重要性或价值方面超过 根据现行法规，对于所有新药，只有经确认安全、有效，才会被批准上市。但是，我们应该意识到没有所谓绝对安全的药物，认识到这一点是很重要的。任何药物都可能有不良反应。因此，只有认定某种药物的益处大于其风险时，FDA才会认为某种药物足够安全，可批准其上市。 In fact, it was only 25 years ago that U.S. drug law first embraced the idea of risk vs. benefit that now the key to new drugs approval. Providing evidence of safety before marketing was first required by Federal Food, Drug and Cosmetic Act in 1938, but not until the Drug Amendments of 1962 did firms also have to show a drug’s effectiveness before marketing. Before any drug gets on the market today, FDA decides—as quickly as a thorough evaluation allows—whether the studies submitted by the drug’s sponsor(usually the manufacturer) show it to be safe and effective for its intend use. embrace [imbreis] vt. 包括; 包含；接受；信奉, 皈依 vt. vi. 拥抱n. 拥抱, 怀抱 cosmetic [k?zmetik] n. 化妆品 adj. 化妆用的; 美容的；装点门面的 Federal Food, Drug and Cosmetic Act联邦食品、药品和化妆法案 Drug Amendments [?mendm?nts] 药品法修正案 thorough [θ?r?u] adj. 彻底的；十足的；考虑周到的 sponsor [sp?ns?] vt. 赞助, 发起, 主办n. 申办者 事实上，直到25年前美国药品管理法才刚刚引入“风险-益处评估”的概念。但是，现今，某种药物能否获批上市取决于“风险-益处评估”的结果。1938年颁布的联邦食品、药品和化妆品法首次规定在新药上市前，申办者需提供可证明药物安全性的资料，但直到1962年的药品法修正案才要求申办者同时提供可证明药物有效性的资料。现今，FDA首先要对新药申办者（通常是制药公司）提供的资料进行深入、彻底的评估，尽快判断这些资料可否证明药物在用于其申报的适应症时安全、有效，最后决定是否批准该药上市。 Promising Experimental Drugs In May 1987, FDA published a regulation to allow broader use of promising experimental drugs such as zidovudine so that desperately ill and dying patients can receive the benefits of those drugs years earlier than was possible before. Promising is the key word in this broadened use of unapproved drugs. FDA can’t allow drugs to be use