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

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Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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18 Nov 2019, 08:15
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New Project RC Butler 2019 - Practice 2 RC Passages Everyday
Passage # 459, Date: 18-Nov-2019
This post is a part of New Project RC Butler 2019. Click here for Details

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.

Spoiler: :: OA
B

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

Spoiler: :: OA
C

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

Spoiler: :: OA
C

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

Spoiler: :: OA
A

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

Spoiler: :: OA
E

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.

Spoiler: :: OA
A

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

Spoiler: :: OA
E

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.

Source: Master GMAT
Difficulty Level: Will be updated after 30+ timers attempts

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Re: Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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18 Nov 2019, 09:29
please give solutions of question number 2,3 and 5
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Re: Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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18 Nov 2019, 23:48
1
prakhar992 wrote:
please give solutions of question number 2,3 and 5

Official Explanation

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

Explanation

This is an explicit idea question. The reference we need is to be found in the first paragraph. There the author explains that the term “unlabeled use” is used to refer to any medically valuable use of any already approved drug that has not yet been specifically recognized by the FDA.

(A) is incorrect because this is a prohibited use, as that term is used in the text.

(B) is incorrect because an unlabeled use is one that was not considered when the drug was originally labeled; it is one discovered later, not one proposed, tested, and rejected.

(D) is incorrect because the author would term this a labeled use.

Finally, (E) is incorrect since this refers to research designed to determine whether a drug has labeled uses because it meets the legal standard of substantial evidence of such uses.

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

Explanation

This is an inference question that requires that we collate information from two parts of the passage. In paragraph two the author refers to physicians who persist in prohibited use for one of two reasons: ignorance or refusal to accept evidence. Then, in the third paragraph, the author refers to physicians who use drugs in violation of labeling instructions as either uninformed or intransigent. The parallelism here tells us that the intransigent physician is the one who rejects the evidence that the drug is ineffective. This is neatly captured by (C).

(A) is incorrect since the intransigent physician prescribes the drug in violation of the labeling provision because he believes that the drug is effective.

(B) is incorrect, for this would be a physician who is anything but intransigent.

As for (D), an intransigent physician might take such actions, but this is not the defining characteristic of an intransigent physician.

Finally, (E) can be eliminated since the author specifically expresses reservations as to whether such behavior is illegal.

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

Explanation

This is an application, and we must find the statement that is most likely to be acceptable to the author. (E) would likely be embraced by the author since it is in agreement with the first paragraph of the passage, which explains that unlabeled uses are created by the time lag between the discovery of the use and the accumulation of data needed to prove that use effective.

(A) is an attractive answer, but it fails upon careful reading. The distinction referred to there is that between approved and unlabeled uses. The distinction that the author attempts to draw is between two types of unapproved uses: unlabeled and prohibited. This is the distinction that has been blurred, says the author, not the distinction between approved and unlabeled.

(B) is incorrect for the same reason. The blurred distinction is between unlabeled and prohibited uses (both types of unapproved uses), not between approved and unlabeled uses.

(C) is incorrect since the distinction between unlabeled and approved uses is a matter of practice, not categorization. The unlabeled use exists because a physician uses the drug in a beneficial but not yet approved way, not because the physician or government decides that the use is unlabeled versus approved.

(D) is incorrect since the author calls for caution in unlabeled use in the final paragraph.

Hope it helps
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Re: Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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19 Nov 2019, 02:47
Got 6 correct in 11:05 minutes including reading.

Please post the explanation for Q.4 . Option E is also nowhere mentioned in the passage. I narrowed down to A and E and ended up marking E.
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Re: Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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19 Nov 2019, 03:01
Can you please provide the solution for Q.7
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Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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19 Nov 2019, 03:21
ArihantJain18 wrote:
Got 6 correct in 11:05 minutes including reading.

Please post the explanation for Q.4 . Option E is also nowhere mentioned in the passage. I narrowed down to A and E and ended up marking E.

Official Explanation

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

Explanation

Here we have an explicit detail question, with a thought reverser. Four of the five choices will be incorrect because they are mentioned in the passage. The remaining choice will be correct because it is the one not explicitly mentioned.

(B) can be eliminated since the medical benefits of an unlabeled usage are specifically mentioned in both the first and final paragraphs.

(C) is incorrect since the time lag that might delay application of a new usage is mentioned in the first paragraph as a reason for permitting that usage, even though that usage has not been formally approved.

(D), too, must be incorrect since the possibility that a manufacturer might not incur the expenses to secure formal approval of a new usage is explicitly mentioned in the first paragraph.

Finally, (E) can be eliminated since the first paragraph also points out that literature is available to ensure that doctors are familiar with the limitations of the unlabeled use.

(A) must be the correct answer, for nowhere in the passage is the cost to the consumer mentioned as a reason for allowing unlabeled usage.

Hope it helps
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Re: Under existing law, a new drug may be labeled, promoted, and advertise  [#permalink]

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19 Nov 2019, 03:32
Mayank2211 wrote:
Can you please provide the solution for Q.7

Official Explanation

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

Explanation

This is a main idea question, and the main idea of this passage, already discussed at some length, is neatly summarized by (E).

Answer (B) is surely the second best answer, but (B) must fail by comparison with (E) because it is too narrow. To be sure, one point the author makes is that the physician who prescribes unlabeled uses should not be subject to legal liability. But that is only part of the argument. That recommendation depends on the distinction between the two types of unapproved uses. (E) makes reference to this additional point. Notice also that in a way (B) is included in (E), so (E) is broad enough to describe the overall point of the author.

(A) is incorrect since the author is cautioning against overzealous enforcement of laws against unlabeled uses.

(C) is incorrect because it is never mentioned in the passage.

Finally, (D) is incorrect because this is at best a minor part of the argument.

Hope it helps
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Re: Under existing law, a new drug may be labeled, promoted, and advertise   [#permalink] 19 Nov 2019, 03:32
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