Under existing law, a new drug may be labeled, promoted, and advertise

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.

1. The author is primarily concerned with

(A) refuting a theory
(B) drawing a distinction
(C) discrediting an opponent
(D) describing a new development
(E) condemning an error



2. According to the passage, an unlabeled use of a drug is any use that

(A) has been reviewed by the FDA and specifically rejected
(B) is medically beneficial despite the fact that such use is prohibited by law
(C) has medical value but has not yet been approved by FDA for inclusion as a labeled use
(D) is authorized by the label as approved by the FDA on the basis of scientific studies
(E) is made in experiments designed to determine whether a drug is medically beneficial



3. It can be inferred from the passage that the intransigent physician (Highlighted)

(A) continues to prescribe a drug even though he knows it is not in the best interests of the patient
(B) refuses to use a drug for an unlabeled purpose out of fear that he may be stigmatized by its use
(C) persists in using a drug for disapproved uses because he rejects the evidence of its ineffectiveness or dangers
(D) experiments with new uses for tested drugs in an attempt to find medically beneficial uses for the drugs
(E) should be prosecuted for violating the Federal Food, Drug, and Cosmetic Act in using drugs for disapproved uses



4. All of the following are mentioned in the passage as reasons for allowing unlabeled uses of drugs EXCEPT

(A) the increased cost to the patient of buying an FDA-approved drug
(B) the medical benefits that can accrue to the patient through unlabeled use
(C) the time lag between initial discovery of a medical use and FDA approval of that use
(D) the possibility that a medically beneficial use may never be clinically documented
(E) the availability of publications to inform physicians of the existence of such uses



5. With which of the following statements about the distinction between approved and unlabeled uses would the author most likely agree?

(A) Public policy statements have not adequately distinguished between uses already approved by the FDA and medically beneficial uses that have not yet been approved.
(B) The distinction between approved and unlabeled uses has been obscured because government regulatory agencies approve only those uses that have been clinically tested.
(C) Practicing physicians are in a better position than the FDA to distinguish between approved and unlabeled uses because they are involved in patient treatment on a regular basis.
(D) The distinction between approved and unlabeled uses should be discarded so that the patient can receive the full benefits of any drug use.
(E) The practice of unlabeled uses of drugs exists because of the time lag between discovery of a beneficial use and the production of data needed for FDA approval.



6. The author regards the practice of using drugs for medically valid purposes before FDA approval as a(n)

(A) necessary compromise
(B) dangerous policy
(C) illegal activity
(D) unqualified success
(E) short-term phenomenon



7. Which of the following statements best summarizes the point of the passage?

(A) Patients have been exposed to needless medical risk because the FDA has not adequately regulated unlabeled uses as well as disapproved uses.
(B) Physicians who engage in the practice of unlabeled use make valuable contributions to medical science and should be protected from legal repercussions of such activity.
(C) Pharmaceutical firms develop and test new drugs, which initially have little or no medical value, but later are found to have value in unlabeled uses.
(D) Doctors prescribe drugs for disapproved purposes primarily because they fail to read manufacturers’ labels or because they disagree with the clinical data about the value of drugs.
(E) The government should distinguish between unlabeled use and disapproved use of a drug, allowing the practice of unlabeled use and condemning disapproved uses.