ADA section 3
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
In the early 1800s, the most reliable and effective medicine of medical doctors, used for a variety of conditions but most notable as a pain reliever, was
opium
One of the consequences of the 1938 Food, Drug and Cosmetic Act was that the federal law of the United States now recognized a difference between____drugs
over-the-counter and prescription-only
What happened as more states and municipalities outlawed opium dens in the US
The cost of black-market opium increased
When 107 people in the US died in 1937 from taking Elixir Sulfanilamide containing diethylene glycol that causes kidney poisoning, why was the federal government unable to intervene on the grounds that the mixture was toxic
There was no legal requirement that medicine be safe
The Department of Agriculture
Administered a law aimed at ensuring that drugs were pure and honestly labeled
What were the provisions added by the 1962 Kefauver-Harris amendments to federal law?
Advertisements for prescriptions drugs need to summarize adverse reactions to the drugs Companies need to seek approval before conducting clinical on humans
A supplement and the primary active chemical in coca, the pure form of which became available in the US in the mid-1800s
Cocaine
Who drafted the bill that later came to be known as the Harrison Act
Dr. Hamilton Wright, the father of American narcotics laws
Match the types of substances that were regulated from the 1980s in the US
Drug precursors - chemical diversion and trafficking Designer Drugs - analogue drug act
By 1928, individuals sentenced for _____ comprised one-third of the total population in federal prisons in the US
Drug violations
The Harrison Act criminalized individual use or possession of certain habit-forming drugs
False
When was the first time that dealers and dispensers of opioids and cocaine in the US had to register, pay a small fee, and use special order forms provided by the Bureau of Internal Revenue
Harrison Act 1914
Identify the reasons why the new drug application provision under the 1938 Food, Drug, and Cosmetic Act was important
It reduced the likelihood of companies run by untrained people introduced new drugs It increased the power and responsibility of the FDA as well as its size
What did the Jones-Miller Act 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
What changes were introduced by the comprehensive Drug Abuse Prevention and Control Act of 1970?
Mandatory minimum penalties were discontinued Drug control was based on both a health and law enforcement perspective The death penalty was eliminated
Under the Comprehensive Drug Prevention and Control Act of 1970, Schedule I drugs have ______ in the US
No currently acceptable medical use in treatment
One of the precursors to the_____ was President Roosevelt's recommendation in 1905 that a law be enacted to regulate interstate commerce in misbranded and adulterated food, drinks, and drugs
Pure Food and Drugs Acts
Match the kinds of impacts of passing laws that criminalize behavior like drug use with the things they influence
Symbolic impacts - these provide status benefits to the supporters of capitalization regardless of how effectively the laws are actually enforced Instrumental impacts - these have effects on local, state, and federal budgets
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
an act to provide the registration of, which collectors of internal revenue,
The Harrison Act 1914
Identify the costs incurred due to drug control enforcement
The cost of imprisoning drug-law violators The cost of crimes committed to purchase black-market drugs The cost of placing law enforcement officers at risk The cost of supporting repressive governments in combating drug trade
How were physisians, dentists, and centenary surgeons affected by the Harrison Act
They had to register to be potential lawful distributers of opioids and cocaine
Which class of drug laws is simular to laws that regulate the safety of other products such as automobiles, furnaces, and toys
The group of laws that regulates the practices of entities that manufactures or dispense legal drugs
Rank the following regulations in the US in the order in which they were implemented, beginning with the first to be implemented
The regulation of pharm manufacturing and sales the regulation of opioids and cocaine the prohibition of alcohol
Critics of the effectiveness of drug-enforcement efforts in the US have pointed out that even as expenditures are escalating, agents are increasing in number, and supply-reduction efforts are increasing in variety,
The supplies of cocaine, heroin, and marijuana appear to have increased
What do an 1875 San Francisco ordinance, and 1882 New York law and an 1890 federal act in the US all have in common
They are regulated the manufacture and the use of opium
How are dietary supplements viewed by federal law?
They are treated more as foods
What are dietary supplements able to of under federal law?
They do not need to be proved to be effective for intended propose They are permitted to make general statements about their contribution to overall health
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
The 1965 Drug Abuse Control amendments referred to amphetamines, barbiturates, and hallucinogens as _____
dangerous drugs
The 1899 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
The most important change brought in by the 1962 Kefauver-Harris amendments was on requiring that every new drug be demonstrated to be
effective for the illnesses mentioned on the label
In 1986, President Reagan first declared that random urine tests for drugs should be performed on all
federal employees in sensitive jobs
Evidence that drug control is effective in restricting supply is found in the
high prices charged on the streets
One of the major concerns of the US Sentate in the late 1950s was that some of the most widely sold over-the-counter medicines were probably____, and there was no law against this
ineffective
The treasury Department
it was responsible for taxing alcohol, and it would later be responsible for enforcing Prohibition
Many orphan drugs are extremely expensive, with some costing more than $100,000 per patient per year because of the
limited market for them
The greatest discrepancy between state and federal drug laws in the realm of ______ regulation
marijuana
Match the models of morphine dependences in the 19th century in the US
medical model of dependence - viewed model morphine-dependent patients as having developed a unique disorder requiring continued treatments moral model of dependence - viewed patients as being merely weak-willed or simply seeking pleasure int the drug's effects
During the period after the Civil War in the US, concerns about drunkenness, crime, and drug misuse, and other forms of deviant behavior came to be associated with___
minority racial groups
An international conference met in 1912 to discuss controls on the opium trade. Great Britian wanted ____ included as well, because these were replacing opium, which led to several countries agreeing to control international trade and domestic sale and use of these substances
morphine, heroin, and cocaine
medicines sold directly to the public under various trademark names and are primarily associated with the period before 1906 in the US
patient medicines
When a company submits an application to investigate a new drug in human clinical trial to the FDA, it is also required to submit all information from
preclinical
The people enforcing the Harrison Act changed in 1919, and they believed that the cure for narcotic dependence was to q
prevent users from having access to drugs
Until the 1920s, following the passage of the Harrison Act, most users of opioids continues to receive them legally through
provate physicians or public clinics
As of 2012, the legality of random, suspicions urine testing for ____ has not been established at the federal level
public school students
The serious between 1890 and 1920 has been called the "nadir" (lowest point) of ________ in the US
race régulations
According to the 1956 Narcotic Drug Control Act, anyone caught____ could receive the death penalty
selling heroin to a person younger than 18
Match the departments
the department of Health, Education, and Welfare - funding for drug-related research, treatment, and prevention efforts the Justice Department's Drug Enforcement Agency - controlling certain drugs directly rather than through tax or interstate commerce laws
The 1906 Pure Food and Drugs Act required habit-forming ingredients to be clearly listed on a drug's label, but____
there was no other federal restrictions on the sale and purchase of drugs
What are the two main reasons for which private corporations adopt tests
they believe that drug-free workers will have better productivity they believe that the company will be protected against suits for drug=related negligence
According tot eh Harrison Act of 1914, physicians_______
were still free to describe heroin, cocaine, or any other available drug