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  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  21
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] According to the passage, an unlabeled use of a drug is any use which______.
选项 A、has been reviewed by the FDA and specifically rejected
B、has medical value but has not yet been approved by FDA for inclusion as a labeled use
C、is authorized by the label as approved by the FDA on the basis of scientific studies
D、is made in experiments designed to determine whether a drug is medically beneficial
答案 C
解析 细节判断题。在文章第一段中，unlabeled use 指任何已被FDA批准使用的药品，它的某种医疗作用还未被 FDA所确认，因此C是正确答案。A的内容不正确，因为它指的是被文明规定禁止的用途。B的内容是错误的，unlabeled use指的是当初该药品被批准使用时还未曾考虑到的用途，但是在以后的使用过程中被发现了，事后因时间关系未曾被官方提出过，也未曾测试过，也未曾否定过。D的内容也是错误的，如果是这样的话，作者一定会认为这是 labeled use。
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