2. A. Cat
B. Dog
C. Both
D. Neither
Cat
Dog
Both
Neither
8%
4%
19%
69%
3. Attempts have been made to
regulate the use of mind-
altering substances since
settlers first arrived in the New
World
The first substance regulated
was alcohol
The temperance movement
in the late 1700s advocated
that people become more
educated about the hazards of
alcohol
Click picture for video
4. Alcohol
1791: Congress passed an excise tax
on whiskey
Opium
1833: US treaty regulated international opium trade
1842:Tax on crude opium shipped to the US
1875: San Francisco prohibiting smoking in opium dens
1890: Only US citizens could manufacture or import opium
Proprietary drugs (over-the-counter drugs)
Pure Food and Drug Act of 1906
5. Do drug laws affect whether people use drugs?
Should drug laws be aimed at drug users, sellers,
or traffickers?
Should the role of government be to inform its
citizens about drugs or to prevent its citizens
from using drugs?
Should a person be prevented from engaging in
self-destructive behavior?
6. Before 1906, patent medicines were
largely unregulated
US Food and Drug Administration (FDA)
was created to assess drug hazards and
prohibit sale of dangerous drugs
Law required drug manufacturers to
report adverse reactions to their
products
Law required that the amount or
proportion of drugs in the medicine had
to be listed on the label
7. A. Stop people from
using opium
B. Establish taxes on
drugs
C. Force people to get
prescriptions for
drugs
D. Keep dangerous
drugs off the market
Stop
peoplefrom
using...
Establish
taxeson
drugs
Force
peopleto
getpresc...
Keep
dangerousdrugsoff...
0%
93%
7%
0%
8. The Harrison Act resulted from the need
to limit opiate use
Law governed the marketing and sale of
narcotics, regulated nonmedical narcotic
use, and made possession of narcotics
without a prescription illegal
Doctors and pharmacists had to keep
records of the prescriptions they wrote
To obtain drugs, an increasing number of
people resorted to criminal activity
9. A. Established taxes
on drugs
B. Made opium illegal
without a
prescription
C. Established jail
time for drug
offenses
Established
taxeson
drugs
M
ade
opium
illegalw
ith...
Established
jailtim
e
for...
8%
0%
92%
10. Began with the
Temperance
Movement
19th Amendment
passed in 1919
Speak-easies
Bootlegging
Increase in organized
crime
Repealed in 1933 by
the 21st Amendment
11. Forbade the recreational use of marijuana,
but not medicinal or industrial uses
Anyone using marijuana was required to pay
a tax – failure to comply meant a large fine
or prison term for tax evasion
AMA and others opposed marijuana
legislation
The Federal Bureau of Narcotics,
established in 1932, later became the Drug
EnforcementAdministration (DEA)
13. Under 1906 guidelines, a drug manufacturer
could not be prosecuted for fatalities due to
toxic drugs
1938 Act required pharmaceutical companies to
file applications with the federal government
demonstrating that all new drugs were safe and
properly labeled
Manufacturers had to submit a “new drug
application” to the FDA, giving the FDA more
authority and responsibility
14. Did not cover drugs that were previously marketed
Drugs had to be proven safe, but not effective
Government had little authority to enact penalties
Manufacturers determined whether a drug would be
sold as a prescription or over-the-counter
Manufacturers conducted their own tests to
determine a drug’s effectiveness
15. A. Established taxes on
new drugs
B. Ensured that drugs
were proven
effective
C. Ensured that drugs
were proven safe
D. Enacted stiff
penalties for false
advertising
Established
taxeson
new
...
Ensured
thatdrugsw
ere...
Ensured
thatdrugsw
ere...
Enacted
stiffpenaltiesfor...
0% 4%
93%
4%
16. A. Absolutely.
B. No, I disagree, it
was a bad idea.
C. I’m not sure or have
no opinion.
Absolutely.
No,Idisagree,itw
asab..
I’m
notsure
orhaveno
...
59%
41%
0%
17. Serious birth defects caused by
thalidomide resulted in
implementation of stronger
regulations regarding drug testing
Kefauver-Harris Amendments, 1962,
gave the FDA the authority to
withdraw drugs from the
marketplace
Drug advertisements directed to
physicians were required to include
the drug’s side effects and its
contraindicated uses
Testing procedures required prior
approval from the FDA
18. 1972 Drug Efficacy Study:The FDA asked the National
Research Council to conduct a study of new drugs
Active ingredients were placed in one of three
categories:
Category I drugs: Determined to be safe, effective, and
properly labeled
Category II drugs: Not generally recognized as safe and
effective, or recognized as mislabeled; must be removed
from medications within six months
Category III drugs: Data insufficient to determine general
recognition of safety and effectiveness
19. A. The FDA had the
authority to remove
unsafe drugs from the
market
B. Taxes on drug
advertisements were
enacted
C. Advertisements must
include side-effects
D. Tests were required
prior to a drug’s
approval
TheFDA
had
theauthorit...
Taxeson
drugadvertise...
Advertisem
entsm
ustinc...
Testsw
ererequired
prior..
7%
0%
7%
85%
20. Comprehensive Drug Abuse Prevention and Control Act
(Controlled Substances Act), effectively replaced all
previous laws dealing with narcotics and dangerous drugs
Expanded community health centers and Public Health
Service hospitals for drug abusers
Established a commission on marijuana and drug abuse
Divided drugs into five categories called schedules
22. Schedule Criteria Examples
I a. High potential for abuse
b. No accepted medical use
c. Lack of accepted safety
Heroin,
marijuana, MDMA
(Ecstasy)
II a. High potential for abuse
b. Currently accepted medical use
c. Abuse may lead to severe dependence
Morphine,
cocaine,
methamphetamine
III a. Potential for abuse less than I and II
b. Currently accepted medical use
c. Abuse may lead to moderate physical dependence or high
psychological dependence
Anabolic steroids,
most barbiturates,
Dronabinol (THC in pill
form)
IV a. Low potential for abuse relative to III
b. Currently accepted medical use
c. Abuse may lead to limited physical or psychological
dependence relative to III
Xanax, barbital,
chloral hydrate,
fenfluramine
V a. Low potential for abuse relative to IV
b. Currently accepted medical use
c. Abuse may lead to limited physical or psychological
dependence relative to IV
Mixture with small
amounts of codeine or
opium
23.
24. Legislation that emphasizes stringent
punishment of the drug user, to reduce drug
demand
Punishment could be waived if the user
completes a drug rehabilitation program
Greatly increased federal prison population and led to
a new Cabinet position, Director of National Drug
Control Policy
Under this law, drug users are punished more
stringently than rapists or robbers
25. A. Emphasized strict
punishment for drug
infractions
B. Allowed offenders to
complete treatment
rather than jail
C. Created lighter
sentences for drug
offenses
D. A & B
E. All of the above
Em
phasized
strictpunis...
Allow
ed
offendersto
co...
Created
lightersentences...
A
&
B
Alloftheabove
11%
4% 7%
78%
0%
26. 1. Should the sale of drug paraphernalia be illegal?
2. Should people using small amounts of illegal drugs for
personal enjoyment receive harsh criminal penalties?
3. What are the advantages and disadvantages of
decriminalizing or legalizing drugs?
4. What impact has drug enforcement had on drug use?
5. Should the vast amount of money spent on stopping
drugs be used differently?
27. Drug paraphernalia:
Items that are aids to using drugs (cigarette-
rolling papers, water pipes, razors, clay pipes,
roach clips, spoons, mirrors, and other products)
Prosecuting individuals for possessing drug
paraphernalia is viewed as a deterrent for
drug use
28. In 1988, Congress proclaimed that the
US would be drug-free by 1995
The monetary expense and human
resources employed to combat illicit
drug use are enormous – yet, the
number of Americans who have used
illegal drugs has increased
The government’s assault on illicit
drugs has resulted in social tension, ill
health, violent crime, compromised
civil liberties, and international conflict
30. A. For legalization
B. Against legalization
C. For legalization,
but only for some
drugs
Forlegalization
Againstlegalization
Forlegalization,butonly...
22%
56%
22%
31. Some argue that
decriminalization would increase
drug use, addiction, and drug-
related deaths
Drug-related crimes might fall,
but the number of addicts would
rise
Legalization would result in more
dysfunctional addicts who would
be unable to support their
lifestyles and drug use through
legitimate means
32. Legal regulation of drugs
would protect drug takers
and save money
Billions of dollars spent on
drug enforcement might
be put to use more
effectively if the money
were directed toward
education and treatment
programs
33.
34. Drug enforcement is
designed to stem the flow of
drugs coming into the US
and to punish the user
To stop drugs at their source,
the State Department works
with a number of foreign
governments
DEA agents help block drugs
from leaving other countries,
eradicate crops, and find and
dismantle illegal laboratories
35. Farmers make more money from coca or
opium crops than from legal crops
On a global scale, less than 10% of illegal
crops are consistently eradicated
Interdiction is especially difficult because of
numerous points of entry
36. Harm reduction
Interventions that respond to
needs of drug users and the
community to reduce harm
caused by illicit drug use
Includes providing sterile syringes to reduce
spread of HIV infection, education, and increased
treatment
Treats drug abuse as a public health problem, not
a criminal problem
37. Normalization
Term used by the Dutch for the
practice of not prosecuting users of
soft drugs such as marijuana
Using some drugs is not illegal, but
drug traffic is illegal
Treatment assists physical and
social well-being of addicts rather
than try to stop their addiction
Result: Netherlands has less drug
use than the US and other
European countries
38. Questionable search warrants in
inner-city communities
People of color are stopped and
searched more often than others
on the basis of “drug courier”
profiles
Despite comparable drug usage, Blacks are
incarcerated at a higher rate thanWhites
Penalties for crack cocaine, used more by poor, are
greater than those for powder cocaine, used more by
middle class
39. Starting in 1984, Congress enacted
mandatory minimum penalties
specifically focusing on drugs and
violent crimes
It has been shown that mandatory
minimum drug sentences have not acted as
deterrents to further crime
Mandatory minimum drug sentences give no latitude
to judges to determine appropriate punishments
Treatment is 15 times more effective for reducing
serious crime than mandatory minimum sentencing
Editor's Notes
Current laws trace back to two pieces of legislation from the early 1900s
Racist fears about deviant behavior, including drug misuse, played a role in the development of drug regulation
Laws were developed to regulate undesirable behaviors
Fraud in patent medicines that were sold directly to the public
False therapeutic claims
Habit-forming drug content
In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines—
“Great American Fraud”
Opium and the Chinese
U.S. was involved in international drug trade
Opium smoking brought to U.S. by Chinese workers
Laws passed against the importation, manufacture, and use of opium– racism involved?
Cocaine
Present in many patent medicines (and, yes, Coca-Cola!)
Viewed as a cause of increasing crime
Racist connections
Required accurate labeling and listing of ingredients
Later amended to require safety testing and testing for effectiveness
A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax
Later expanded to include other federal controlled-substance regulations
The Pure Food and Drugs Act (1906)
U.S. Department of Agriculture
Goal: drugs are pure and honestly labeled
Harrison Act (1914)
U.S. Treasury Department
Goal: taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers
1. Purity
The contents of the product must be accurately listed on the label
FDA encouraged voluntary cooperation and compliance
1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels
Safety
Originally—no legal requirement that medications be safe
1938 Food, Drug, and Cosmetic Act required pre-market testing for toxicity
Companies required to submit a New Drug Application (NDA) to the FDA
FDA became a gatekeeper and expanded greatly
Directions must be included
Adequate instructions for consumer OR
Drug can be used only with physician prescription
3. Effectiveness
1962 Kefauver-Harris Amendments
Pre-approval required before human testing
Advertising for prescription drugs must include information about adverse reactions
Every new drug must be demonstrated to be effective for the illnesses mentioned on label
DIETARY SUPPLEMENTS Regulated more like food than drugs
Labels must be accurate
Products can’t make unsubstantiated direct claims
Products can make general health claims
Products can be marketed without first proving safety
Early enforcement
18th Amendment
Physicians and pharmacists arrested; growth of illegal drug trade
Stiffer penalties
Jones-Miller Act
Prohibition on importation of opium for heroin
Prison vs. rehabilitation
Punishment seemed not to be working
“Narcotic farms”
Bureau of Narcotics (Treasury Department)
“Drug Czar”
Marijuana Tax Act
Mandatory minimum sentences (1951)
1956 Narcotic Drug Control Act toughened penalties
Drug Abuse Control Act Amendments of 1965
Added new classes of drugs
Comprehensive Drug Abuse Prevention and Control Act of 1970
Replaced or updated all previous laws
Drugs controlled by the Act are under federal jurisdiction
In some cases, state and federal laws conflict
Prevention and treatment funding increased
Direct control of drugs, not control through taxation, is the goal
Enforcement separated from scientific and medical decisions
Possession and selling penalties
Omnibus Drug Act
Drug precursors
Drug paraphernalia
Office of National Drug Control Policy established
Preclinical research and development
IND submitted to the FDA
Clinical research and development
Phase One—low doses, 20-80 healthy volunteers
Phase Two—few hundred patients who could benefit
Phase Three—typically 1,000-5,000 patients
Permission to market
May require 10+ years and costs $1+billion
Only 31 new drugs approved by FDA in 2008
Orphan Drug Act—tax and other financial incentives
Prescription Drug Marketing Act of 1988—regulation of free samples, etc.
1997 FDA Modernization Act—guidelines for postmarketing reporting, distribution of information on off-label uses
Budget
International programs
Other federal agencies
Other costs
Cost of prison population
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom
Drug use has not been eliminated
About 10-15 percent of illegal drug supply is seized each year
When supplies are restricted, prices go up
Higher prices and increased difficulty in obtaining drugs may deter some would-be users
Difference in
penalties from state
to state
Federal law
overrides state law
Significant growth
in number of
Americans in prison
In 2007 the number
rose to 5.06 prisoners
per thousand and in
2008 it dropped
slightly to 5.04 per
thousand.