首页
登录
职称英语
Under existing law, a new drug may be labeled, promoted, and advertised only
Under existing law, a new drug may be labeled, promoted, and advertised only
游客
2024-12-26
21
管理
问题
Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiveness have been demonstrated and of which the Food and Drug Administration (FDA) has approved, or so-called "approved uses". Other uses have come to be called "unapproved uses" and cannot be legally promoted. In a real sense, the term "unapproved" is a misnomer because it includes in one phrase two categories of marketed drugs that are very different; drugs which are potentially harmful and will never be approved, and already approved drugs that have "unapproved" uses. It is common for new research and new insights to demonstrate valid new uses for drugs already on the market. Also, there are numerous examples of medical progress resulting from the serendipitous observations and therapeutic innovations of physicians, both important methods of discovery in the field of therapeutics. Before such advances can result in new indications for inclusion in drug labeling, however, the available data must meet the legal standard of substantial evidence derived from adequate and well-controlled clinical trials. Such evidence may require time to develop, and, without initiative on the part of the drug firm, it may not occur at all for certain uses. However, because medical literature on new uses exists and these uses are medically beneficial, physicians often use these drugs for such purposes prior to FDA review or changes in labeling. This is referred to as "unlabeled uses" of drugs.
A different problem arises when a particular use for a drug has been examined scientifically and has been found to be ineffective or unsafe, and yet physicians who either are uninformed or who refuse to accept the available scientific evidence continue to use the drug in this way. Such use may have been reviewed by the FDA and rejected, or, in some cases, the use may actually be warned against in the labeling. This subset of uses may be properly termed "disapproved uses."
Government policy should minimize the extent of unlabeled uses. If such uses are valid? and many are? it is important that scientifically sound evidence supporting them be generated and that the regulatory system accommodate them into drug labeling. Continuing rapid advances in medical care and the complexity of drug usage, however, makes it impossible for the government to keep drug labeling up to date for every conceivable situation. Thus, when a particular use of this type appears, it is also important, and in the interest of good medical care, that no stigma be attached to "unapproved usage" by practitioners while the formal evidence is assembled between the time of discovery and the time the new use is included in the labeling. In the case of "disapproved uses," however, it is proper policy to warn against these in the package insert, whether use of a drug for these purposes by the uninformed or intransigent physician constitutes a violation of the current Federal Food, Drug and Cosmetic Act is a matter of debate that involves a number of technical and legal issues. Regardless of that, the inclusion of disapproved uses in the form of contraindications, warnings and other precautionary statements in package inserts is an important practical deterrent to improper use. Except for clearly disapproved uses, however, it is in the best interests of patient care that physicians not be constrained by regulatory statutes from exercising their best judgment in prescribing a drug for both its approved uses and any unlabeled uses it may have. [br] Which of the following is true with disapproved drugs?
选项
A、There is nothing to prove that such drugs are not safe.
B、It is affirmative that such drugs are ineffective and dangerous.
C、Physicians do not intend to use such drugs.
D、Such drugs have never been tested by FDA
答案
B
解析
细节判断题。在文章第二段中,作者提到在药品使用过程中会出现一些问题,如有些药被检测无效或不安全,但有些医生不知情或不接受检测结果而继续使用此类药物。因此,只有答案B是正确的。其他选项与文章意思相反,故不正确。
转载请注明原文地址:https://tihaiku.com/zcyy/3885968.html
相关试题推荐
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonlyf
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonlyf
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonlyf
McCarthyismis______inthe1950spromotedbyaU.S.senatornamedMcCarthy.A、an
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonly
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonly
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonly
Underexistinglaw,anewdrugmaybelabeled,promoted,andadvertisedonly
Manyofthehomeelectricgoodswhichareadvertisedasliberatingthemode
Manyofthehomeelectricgoodswhichareadvertisedasliberatingthemode
随机试题
Howwillyouwriteanabstract?Youshouldwriteitinas_____________aspossi
图书馆服务语言的基本要求:()A.标准、确切 B.礼貌、文雅 C.专业、适
(2017年真题)根据《中华人民共和国证券投资基金法》关于基金份额持有人大会议事
隐藏图形测验佥中,要求被试在较复杂的图开中(见图1中的右图)把隐蔽在其中的简单图
男性,25岁,右膝关节扭伤2周,行走时打软,不稳,有“错位”感,下列哪项检查可诊
在态度转变的P-O-X模型中,()则系统处于平衡状态多选A.如果三种关系都是
进口货物的申报期限为装载货物的运输工具申报进境之日起()内,进口货物装载货物
某建设项目第一年计划投资额为1000万元,第二年计划投资额为500万元,建设期价
背景资料: 甲公司中标城市立交桥工程,桩基础为端承桩,承台墩柱盖梁均为现
男性,20岁,原发性肾病综合征患者,首次治疗,每日用泼尼松60mg,3周后尿蛋白
最新回复
(
0
)