单项选择题
| 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 socalled "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 arc
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 arc 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 cure, 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 chug for both its approved uses and any unlabeled uses it may have. |