From the time they were first proposed, the 1962 Amendments to the

Question

From the time they were first proposed, the 1962 Amendments to the Food, Drug, and Cosmetic Act have been the subject of controversy among some elements of the health community and the pharmaceutical industry. The Amendments added a new requirement for Food and Drug Administration approval of any new drug: The drug must be demonstrated to be effective by substantial evidence consisting of adequate and well controlled investigations. To meet this effectiveness requirement, a pharmaceutical company must spend considerable time and effort in clinical research before it can market a new product in the United States. Only then can it begin to recoup its investment. Critics of the requirement argue that the added expense of the research to establish effectiveness is reflected in higher drug costs, decreased profits, or both, and that this has resulted in a “drug lag. ”The term drug lag has been used in several different ways.

It has been argued that the research required to prove effectiveness creates a lag between the time when a drug could theoretically be marketed without proving effectiveness and the time when it is actually marketed. Drug lag has also been used to refer to the difference between the number of new drugs introduced annually before 1962 and the number of new drugs introduced each year after that date. It is also argued that the Amendments resulted in a lag between the time when new drugs are available in other countries and the time when the same drugs are available in the United States. And drug lag has also been used to refer to a difference in the number of new drugs introduced per year in other advanced nations and the number introduced in the same year in the United States. Some critics have used drug lag arguments in an attempt to prove that the 1962 Amendments have actually reduced the quality of healthcare in the United States and that, on balance, they have done more harm than good. These critics recommend that the effectiveness requirements be drastically modified or even scrapped.

Most of the specific claims of the drug lag theoreticians, however, have been refuted. The drop in new drugs approved annually, for example, began at least as early as 1959, perhaps five years before the new law was fully effective. In most instances, when a new drug was available in a foreign country but not in the United States, other effective drugs for the condition were available in this country and sometimes not available in the foreign country used for comparison. Further, although the number of new chemical entities introduced annually dropped from more than 50 in 1959 to about 12 to 18 in the 1960s and 1970s, the number of these that can be termed important—some of them of “breakthrough” caliber—has remained reasonably close to 5 or 6 per year. Few, if any, specific examples have actually been offered to show how the effectiveness requirements have done significant harm to the health of Americans. The requirement does ensure that a patient exposed to a drug has the likelihood of benefiting from it, an assessment that is most important, considering the possibility, always present, that adverse effects will be discovered later.   1 
 1. The author is primarily concerned with

(A) outlining a proposal
(B) evaluating studies
(C) posing a question
(D) countering arguments
(E) discussing a law

2 
 2. The passage states that the phrase “drug lag” has been used to refer to all of the following situations EXCEPT

(A) a lag between the time when a new drug becomes available in a foreign country and its availability in the United States
(B) the time period between which a new drug would be marketed if no effectiveness research were required and the time it is actually marketed
(C) the increased cost of drugs to the consumer and the decreased profit margins of the pharmaceutical industry
(D) the difference between the number of drugs introduced annually before 1962 and the number introduced after 1962
(E) the difference between the number of new drugs introduced in a foreign country and the number introduced in the United States

3 
 3. The author would most likely agree with which of the following statements?

(A) Whatever “drug lag” may exist because of the 1962 Amendments is justified by the benefit of effectiveness studies.
(B) The 1962 Amendments have been beneficial in detecting adverse effects of new drugs before they are released on the market.
(C) Because of the requirement of effectiveness studies, drug consumers in the United States pay higher prices than consumers in foreign countries.
(D) The United States should limit the number of new drugs which can be introduced into this country from foreign countries.
(E) Effectiveness studies do not require a significant investment of time or money on the part of the pharmaceutical industry.

4 
 4. The author points out the drop in new drugs approved annually before 1959 in order to

(A) draw an analogy between two situations
(B) suggest an alternative causal explanation
(C) attack the credibility of an opponent
(D) justify the introduction of statistics
(E) show an opponent misquoted statistics

5 
 5. The author implies that the non availability of a drug in the United States and its availability in a foreign country is not necessarily proof of a drug lag because this comparison fails to take into account

(A) the number of new drugs introduced annually before 1959
(B) the amount of research done on the effectiveness of drugs in the United States
(C) the possible availability of another drug to treat the same condition
(D) the seriousness of possible unwanted side effects from untested drugs
(E) the length of time needed to accumulate effectiveness research

Source: Master GMAT

VeritasPrepBrian · Accepted Answer

I think you nailed it there actually - the author is trying to undermine the credibility of one side of the argument...but that's not that same as  attacking  the credibility of an  opponent  (the person making that argument). C falls victim to that precise language...it's not about the opponent, it's about the argument.

And note on this - it's so easy for the testmaker to use our own personal biases against us. We kind of seek out drama (look at reality TV, Twitter trolls, etc.), so we'll gravitate toward "attack," "criticize," etc. in these Function questions (i.e. "the author does X in order to Y"). But that's really rare in the text itself...we get a little bored with the subject matter so we're looking for interpersonal drama, but more often than not the author stays within the scope of the argument and doesn't really attack or criticize the people who make it.

prashant6923 · Answer

5. The author implies that the non availability of a drug in the United States and its availability in a foreign country is not necessarily proof of a drug lag because this comparison fails to take into account

(A) the number of new drugs introduced annually before 1959
(B) the amount of research done on the effectiveness of drugs in the United States
(C) the possible availability of another drug to treat the same condition
(D) the seriousness of possible unwanted side effects from untested drugs
(E) the length of time needed to accumulate effectiveness research

"In most instances, when a new drug was available in a foreign country but not in the United States, other effective drugs for the condition were available in this country and sometimes not available in the foreign country used for comparison." 
Thus C

guptakashish02 · Answer

Can anyone please explain Q-3 .
From where it is inferred that option A is correct.
Thanks

Diwakar003 · Answer

Hi Prashant,

Quoting from the para

Some critics have used drug lag arguments in an attempt to prove that the 1962 Amendments have actually reduced the quality of healthcare in the United States and that, on balance, they have done more harm than good.  These critics recommend that the effectiveness requirements be drastically modified or even scrapped. Most of the specific claims of the drug lag theoreticians, however, have been refuted.  The drop in new drugs approved annually, for example, began at least as early as 1959. perhaps five years before the new law was fully effective, perhaps five years before the new law was fully effective

The author says that reduction in number of drugs was caused back in 1959 and not in 1962. Author is giving an alternate cause for the reduction in no.of drugs. Hence B.

Cheers!

AdityaHongunti · Answer

VeritasKarishma   GMATNinja   GMATNinja Two  DmitryFarber  @mikemcgaryy  broall

4. The author points out the drop in new drugs approved annually before 1959 in order to

(A) draw an analogy between two situations
(B) suggest an alternative causal explanation
(C) attack the credibility of an opponent
(D) justify the introduction of statistics
(E) show an opponent misquoted statistics

Only B and C are contenders ... Both seem credible to me. 
B - It does look like an alternative explanation
C- as per the function of the paragraph in the passage as a whole, it seems like he is mentioning the stats to limit the credibility of the arguments made by the critics.

COuld you please explain the difference??

AdityaHongunti · Answer

So basically, option C can mean that the author is criticizing the critics themselves and not their arguments... By saying "attacking the credibility of the opponent" , the author is instead trying to criticise the character of the opponent rather than the argument he makes...

Got it... Thank you so much for pointing this out... Ambiguity can be a ..... (You know)

Posted from my mobile device

VeritasPrepBrian · Answer

Yep, exactly - and really when it says "opponent" that's talking about the person (or people) and not the argument itself.

I'm always super skeptical about answers that say the author's reason for doing something is to criticize/attack a person (or opponent, scientist, whatever). It's just so rarely justified by the text (and kind of hard to fit in a dense passage that also allows for specific detail questions) but it's so tempting to us when we're non-experts on a subject.

Anyway...you're right that ambiguity can be a ***** but here "opponent" I'd say is pretty specific that it's attacking a person, and that's something to look out for (not that it appears a ton, but when it does it should stand out as a likely trap).

bpdulog · Answer

2. The passage states that the phrase “drug lag” has been used to refer to all of the following situations EXCEPT

(A) a lag between the time when a new drug becomes available in a foreign country and its availability in the United States
(B) the time period between which a new drug would be marketed if no effectiveness research were required and the time it is actually marketed
(C) the increased cost of drugs to the consumer and the decreased profit margins of the pharmaceutical industry
(D) the difference between the number of drugs introduced annually before 1962 and the number introduced after 1962
(E) the difference between the number of new drugs introduced in a foreign country and the number introduced in the United States

E is the wrong answer. The passage is comparing new drugs in the US and those same drugs in foreign countries and is not comparing number vs number.

MayankDimri · Answer

Can someone explain Q1? I chose 'Discussing the law' as the answer. In the first paragraph the author introduces the topic and in the subsequent paragraphs shares the perspectives of critics and his very own (refutes the claims sighting reasons). 'Countering arguments' (right answer) is only described in the third paragraph and does not cover the pointers discussed in the first and second paragraphs.

MBAB123 · Answer

Even I was kind of debating between the 2 but this is what led me to D -

1. If the Author was just discussing the law - it would have probably been more about it's origin, why it was enacted, reaction of the public, some stats about it,etc
2. I understand that the Countering arguments is only really given in the 3rd paragraph but if an author is presenting counter arguments, he would have first have to introduce the topic and the arguments of his opponents.
3. The overall tone of the author is pretty defensive and the passage is not really explanatory in nature.

I know this might not be an exact justification but hope this helps.

VerbalBot · Answer

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From the time they were first proposed, the 1962 Amendments to the

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