Chapter 3
Evidence that drug control is effective in restricting supply is found in the _____.
high prices charged on the streets
Many orphan drugs are extremely expensive, with some costing more than $100,000 per patient per year because of the ______.
limited market for them
Many orphan drugs are extremely expensive, with some costing more than $100,000 per patient per year because of the _______.
limited market for them
Where did the 1906 Pure Food and Drugs Act achieve by regulating interstate commerce?
it brought the federal government full force into the drug marketplace
The Department of Agriculture
It administered a law aimed at ensuring that drugs were pure and honestly labeled
According to the Harrison Act of 1914, physicians ______.
were still free to prescribe heroin, cocaine, or any other available drug
After the 1965 Drug Abuse Control amendments, for the first time, the Bureau of Narcotics and Dangerous Drugs faced widespread disregard of drug laws by young people who ______.
were not members of the underprivileged and criminal classes
What do an 1875 San Francisco ordinance, an 1882 New York law, and an 1890 federal act in the US all have in common?
They all regulated the manufacture and use of opium
Identify the important classes of drug laws.
A group of laws that has resulted in the criminalization of certain types of drug use, possession, and sales A group of laws that regulates the practices of entities that manufacture or dispense legal drugs
What were the provisions added by the 1962 Kefauver-Harris amendments to federal law?
Advertisements for prescription drugs need to summarize adverse reactions to the drug. Companies need approval before conducting clinical trials on humans.
What were the provisions added by the 1962 Kefauver-Harris amendments to federal law?
Advertisements for prescription drugs need to summarize adverse reactions to the drug. Companies need to seek approval before conducting clinical trials on humans.
In response to the end of the Prohibition and to charges of corruption in the previous Narcotics Devision, Congress formed a _____ in the Treasury Department in 1930.
Bureau of Narcotics
Who drafted the bill that later came to be known as the Harrison Act?
Dr. Hamilton Wright, the father of American narcotics laws
As part of international efforts aimed at reducing drug supply, the ______ has agents in more than 40 countries assisting the local authorities in eradicating drug crops, locating and destroying illicit laboratories, and interfering with the transportation of drugs out of those countries.
Drug Enforcement Agency
Identify the reasons why the new drug application provision under the 1938 Food, Drug, and Cosmetic Act was important?
It increased the power and responsibility of the FDA as well as its size. It reduced the likelihood of companies run by untrained people introducing new drugs.
What did the Jones-Miller Act passed by Congress in 1922 do?
It officially made the user of illegally obtained opioids and cocaine a criminal. It more than doubled the maximum penalties for dealing in illegally imported drugs.
The Treasury Department
It was responsible for taxing alcohol, and it would later be responsible for enforcing Prohibition
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 as the side effects it may trigger?
Phase One
Which sedative and sleeping pill caused a disaster in the late 1950s that raised public awareness and congressional concern about ineffective medicines in the US, causing major reforms to be implemented?
Thalidomide
Which sedative and sleeping pill caused the disaster in the late 1950s that raised public awareness and congressional concern about ineffective medicines in the US, causing major reforms to be implemented?
Thalidomide
Which law was passed as a result of the poisoning of 107 people by Elixir Sulfanilamide?
The 1938 Food, Drug, and Cosmetic Art
What is otherwise known as "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?"
The Harrison Act of 1914
Identify the costs involved in drug-control enforcement by federal agencies.
The cost of housing drug-law violators in state prisons and local jails. The incalculable price of placing federal agents in danger of losing their lives to combat the drug trade. The cost of crimes committed to purchase drugs at black-market prices.
Identify an issue that was cleared up by the 1994 Dietary Supplement Health and Education Act regarding the marketing of dietary supplements.
The labels are permitting to make general statements about their contribution to overall health and well-being.
What are the two main reasons for which private corporations adopt drug tests?
They believe that the company will be protected against suits for drug-related negligence. They believe that drug-free workers will have better productivity.
Phase Three
This phase administers a drug to 1,000 to 5,000 individuals with the disease or symptom for which the drug is intended
Phase One
This phase encompasses studies with relatively low doses of a drug on a limited number of healthy people
Phase Two
This phase involves a few hundred patients who have the condition a drug is designed to treat
The Department of Health, Education, and Welfare
This was given funding for drug-related research, treatment, and prevention efforts.
The Justice Department's Drug Enforcement Agency
This was given responsibility for controlling certain drugs directly rather than through tax or interstate commerce laws.
T or F 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
One of the precursors to the Pure Food and Drugs Act was the 1906 publication of ________, which exposed the horrible unsanitary conditions in the meatpacking industry and shocked Congress and America.
Upton Sinclair's The Jungle
When does a pharmaceutical company, desiring to introduce a new drug, supply to the FDA a "Notice of Claimed Investigational Exemption for a New Drug" (IND)?
When it is ready to study the effects of a compound on humans
A critical change in the 1938 Food, Drug, and Cosmetic Act was the requirement that ______.
a manufacturer must test a new drug for toxicity before it could be marketed
According to the 1956 Narcotic Drug Control Act, ______ had to result in a jail term, and no suspension, probation, or parole was allowed.
any drug offense except first offense possession
The US is providing increased military aid in the form of helicopters, defensive weapons, uniforms, and other supplies to be used in combating drug trafficking only to countries that ______.
do not engage in a consistent pattern of gross violations of human rights
What changes were introduced by the Comprehensive Drug Abuse Prevention and Control Act of 1970?
drug control was based on both a health and law enforcement perspective the death penalty was eliminated mandatory minimum penalties were discontinued
In 1986, President Reagan first declared that random urine tests for drugs should be performed on all _______.
federal employees in sensitive jobs
The greatest discrepancy between state and federal drug laws is in the realm of _____ regulation.
marijuana
During the period after the Civil War in the US, concerns about drunkenness, crime, drug misuse, and other forms of deviant behavior came to be associated with ______.
minority racial groups
According to the 1938 Food, Drug, and Cosmetic Act, a company had to submit a(n) _______ ______ _______ (NDA) to the FDA that included "full reports of investigations 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
Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, Schedule I drugs have _____ in the US.
no currently acceptable medical use in treatment
According to the 1906 Pure Food and Drugs Act, misbranding referred ______.
only to labels, not to general advertising
In the early 1800s in the US, physicians prescribed various forms of _____ liberally and with only limited concern about patients developing dependence.
opium
Until the 1920s, following the passage of the Harrison Act, most users of opioids continued to receive them legally through ______.
private physicians or public clinics
As of 2012, the legality of random, suspicionless urine testing for _______ has not been established at the federal level.
public school students
In the early 1900s, Dr. Hamilton Wright, the father of American narcotics laws, decided the US could gain favored trading status with China by leading international efforts to _______.
reduce opium importation
Early enforcements efforts of the Harrison Act, prior to the 1920s, focused on _______.
smugglers and opium dens
Which of the following drug testing methods is more invasive of privacy than the rest?
supervised urine testing
Rank the regulations in the US in the order in which they were implemented, beginning with the first to be implemented.
the regulation of pharmaceutical manufacturing and sales the regulation of opioids and cocaine the prohibition of alcohol
After the Narcotic Division in the US arrested around 25,000 physicians between 1919 and 1929 for supplying opioids and cocaine to dependent users, _______.
there was no legal way to obtain these drugs then
symbolic impacts
these cause people who promote such laws to gain immediate social status by being identified with political power and as supporting goodness, morality, and decency
instrumental impacts
these refer to the consequences to those affected by the implementation of such laws, including those who are arrested and their families, and those whose livelihood depend upon the implementation of these laws
Until 1912, the US Food and Drug Administration tested products and pursued any that ______.
were adulterated or didn't properly list any important ingredients
According to the 1906 Pure Food and Drugs Act, the packaging of drugs had to indicate _____.
what proportion of habit forming drugs they included
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 1988 amendment of the Anti-Drug Abuse Act brought back the death penalty for drug-related murders, and a further amendment in 1994 extended the death penalty to ______.
drug kingpins
By 1928, individuals sentenced for _______ comprised 1/3 of the total population in federal prisons in the US.
drug violations
The 1850s in the US saw the introduction of _____, which was a potent delivery system for morphine that led to increasing medical recognition of the negative aspects of "morphinism".
hypodermic syringes
The 1850s in the US saw the introduction of _______, which was a potent delivery system for morphine that led to increasing medical recognition of the negative aspects of "morphinism".
hypodermic syringes
The 1906 Pure Food and Drugs Act prohibited _______.
interstate commerce in adulterated or misbranded food and drugs
The people enforcing the Harrison Act changed in 1919, and they believed that the cure for narcotic dependence was to ________.
prevent users from having access to drugs
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 period between 1890 and 1920 has been called the "nadir" (lowest point) of _______ in the US.
race relations
The Orphan Drug Act passed by Congress in 1938 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
What happened as more states and municipalities outlawed opium dens in the US?
the cost of black market opium increased
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