Chapter 3: Drug Policy

the most important change brought in by the 1962 Kefauver- Harris amendments was one requiring that every new drug be demonstrated to be ____.

effective for the illnesses mentioned on the label

The comprehensive Drug Abuse Prevention and Control Act of 1970

established schedules of controlled substances and moved enforcement to the justice department

The 1906 Pure Food and Drugs Act required drug manufacturers to prove that their drugs were an effective treatment for some diseases

false

In the early 1800's ____ was the medical doctor's most reliable and effective medicine that was used for variety of conditions but mainly for pain relief

opium

as of 2012, the legality of random, suspicionless urine testing for ___ has not been established at the federal level

public school students

which of the following drug testing methods is more invasive of privacy than the rest?

supervised urine testing

which sedative and sleeping pill caused a disaster in teh late 1950's that raised publuc awareness and congressional concern about ineffective medicines in the US, causing major reforms to be implemented

thalidomide

An economic study of U.S. efforts to eradicate coca fields in South America indicated

that even if we produced massive disruption of one country's supply, market forces would replace the supply within two years

which law was passed as a result of the poisoning of 107 people by Elixir Sulfanilamide?

the 1938 Food, Drug and Cosmetic Act

Important changes to the regulation of drugs by the Food and Drug Administration occurred in 1938 and 1962, largely in response to

the Elixir Sulfanilamide posionings and birth defects from thalidomide

What happened as more states and municipalities outlawed opium in the US

the cost of black- market opium increased

the 1906 pure food and drugs act

the department of agriculture

When the US imposed chinese workers after the civil war, mainly to help build the rapidly expanding railroads, what did some of them bring with them?

the habit of smoking opium

How were physicians, dentists, and veterinary surgeons affected by the Harrison Act of 1914

they had to register to be potential lawful distributors of opioids and cocaine

in the context pf urine testing for detecting drug use, the higher the amount required for a positive result, the longer the detection time

true

until 1912, the US Food and Drug administration tested products and pursued any that ___

were adulterated or didn't properly list any important ingrediants

___ is a narcotic and the primary active chemical in opium from which heroin is derived

morphine

HArrison Act of 1914

"An act to provide for the registration of, with collectors of internal revenue, and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes." ** Basically it's a law that regulated and taxed the production, importation, and distribution of opiates." **

what did the jones- miller act passed by congress in 1922 do?

1. It more than doubled the maximum penalties for dealing in illegally imported drugs 2. It officially made the user of illegally obtained opioids and cocaine a criminal

identify the reasons why the new drug application provision under the 1938 Food, Drug, and Cosmetic Act was important

1. it increased the power and responsibility of the FDA as well as its size 2. It reduced the likelihood of companies run by untrained people introducing new drugs

The Marijuana Tax Act was passed in

1937

Which of the following terms is defined as chemicals that are close relatives of controlled substances but not themselves listed on one of the controlled substance schedules?

Designer Drugs

Congress passed the controlled Substance Analogue Enforcement Act in 1986, saying that any drug or any chemical intended for humans use that is substantially similar to a controlled substance should be excluded from the controlled substance schedules

False

which of the following statements is true of using saliva samples as a testing method to detect drug use?

They detect only fairly recent drug use, up to one a day

The broadest impact on drug use in the US during the late 19th century and early 20th century came from the widespread legal distribution of patent medicines, which were dispensed by traveling peddlers and were readily available at local stores for self- medication

True

The year is 1907. A new drug has been marketed as a "blood energizer that will cure many ailments" with a label that accurately lists its ingredients. It has not been proven to be safe or effective. According to the laws of the time, this product is legal.

True

one of the precursors to the Pure Food and Drugs Act was 1906 publication of ____, which exposed the horribly unsanitary conditions in the meatpacking industry and shocked Congress and America.

Upton Sinclair's The Jungle

the group of laws that regulates the practices of entities that manufacture or dispense legal drugs

Which class of drug laws is similar to laws that regulate the safety of other products such as automobiles, furnaces, and toys

the largely unsubstantiated fear that ___ was important in building support for federal drug control laws among southern senators and congressmen in the US despite their opposition to increasing federalism

cocaine use was responsible for an increase in violent crimes

the harrison act of 1914 made it illegal tp possess or use heroin or marijuana

false

According to current federal law, a fine of up to $10,000 and loss of all federal privileges (including student loans and grants) can result from conviction

for possession of small amounts of a controlled substance

the U.S. supreme Court has ruled that it is legal to use urine tests to screen students in public high schools for drug use

if they are involved in extracurricular activities

With reference to the marketing of dietary supplements, which of the following was cleared by the 1994 Dietary Supplement Health and Education Act

it broadened the definition of dietary supplements to include not only vitamins, mineral, and proteins but also herbs and herbal extracts

What did the 1906 Pure Food and Drugs Act achieve by regulating interstate commerce?

it brought the federal government full force into the drug marketplace

Which of the following statements is true of phase one of clinical investigations after the United States Food and Drug Administration (FDA) authorizes the testing of the drug in humans?

it encompasses studies with relatively low doses of the drug on a limited number of healthy people

In the context of marketing a new drug, which of the following is the significance of the 1997 Food and Drug Administration (FDA) Modernization Act?

it included the guidelines for annual postmarketing reporting by the companies of adverse reactions to some medications

the introduction of ___ by the 1986 Anti- Drug Abuse Act has contributed greatly to a huge growth in prison populations over the past 20 years

longer sentences, mandatory minimums, and no- parole provisions

In the early 1900's in the United States, fears about opium and cocaine were closely linked to

minority and racial groups

according to the 1938 food, drug, and cosmetic act, a company had to submit an ____ (NDA) to the FDA that included "full reports of investifations which have been made to show whether or not a drug is safe for use, "which had to be approved before the drug could be marketed

new drug application

According to the 1906 Pure Food and Drugs Act, misbranding referred ____.

only to labels, not to general advertising

One concern that led to the initial passage of federal drug-control legislation in 1906 was

patent medicines

Once the FDA authorizes the testing of a drug in humans, in which phase of clinical investigation does a company learn about how that drug is absorbed and excreted in healthy people, as well ad the side effects it may trigger

phase one

According to the text, which of the following most accurately describes the recent drug laws in portugal?

possession for personal use of all drugs is decriminialized

as FDA officials investigated more and more cases, they determined that many violations of the 1906 Pure Food and Drugs Act were unintentional and caused primarily by poor manufacturing techniques and an absence of ___.

quality- control measures

the orphan Druf Act passed by Congress in 1983 offered tax incentives and exclusive sales rights for a guaranteed seven years for any company developing a drug for ____.

rare disorders afflicting no more than 200,000 people

In the early 1900's, Dr. Hamilton Wright, the father of american ba==narcotics laws, decided the US could gain favored trading status with CHina by leading international efforts to ___.

reduce opium importation

The Harrison Act of 1914

required pharmacists and physicians to register and pay a tax to dispense certain drugs

1994 Dietary Supplement Health and Education Act

the labels are permitted to make general statements about their contribution to overall health and well- being

Harrison Act of 1914

the treasury department

instrumental impacts

these have effects on local, state, federal budgets

symbolic impacts

these provide status benefits to the supporters of criminalization regardless of how effectively the laws are actually enforced

After the passage of the Harrison act of 1914, physicians____.

were still free to prescribe heroin, cocaine, or any other available drug

According to the 1906 Pure Food and Drugs Act, the packaging of drugs had to indicate

what proportion of habit- forming drugs they included

what does the pharmaceutical company, desiring to introduce a new drug, supply to the FDA a "Notice of Claimed Investigational Exemption for a New Drug

when it is ready to study the effects of a compound on humans