2. 职称英语
  3. 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2023-12-14  32
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] The author is primarily concerned with______.
选项 A、refuting a theory
B、drawing a distinction
C、discrediting an opponent
D、condemning an error
答案 B
解析 主旨题。作者在文章的第一段就区分了“未曾标明的药品”作用及“未经证实的药品”用途，然后指出了将两者区分开来的重要性。因为本文没有引用任何有关驳斥的理论根据，故A的内容是错误的。C的内容不正确，由于文章未曾提及任何对立面。D的选项可以被排除，因为没有证据表明“未曾标明作用”的药品使用是最近的行为。
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