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

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. 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. 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. 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. 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. 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