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Goldberg Chapter 4 Drugs & the Law
A. Cat
B. Dog
C. Both
D. Neither
Cat
Dog
Both
Neither
0% 0%
50%50%
 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
 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
 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?
A. A problem best
handled by the
legal system
B. A problem best
handled as a public
health issue
A
problem
besthandled...
A
problem
besthandled...
100%
0%
A. Go to the future
B. Go to the past
C. Stay right here
Go
to
the
future
Go
to
the
past
Stayrighthere
0% 0%0%
 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
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...
25%
50%
0%
25%
 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
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...
0% 0%
100%
 Began with the
Temperance
Movement
 19th Amendment
passed in 1919
 Speak-easies
 Bootlegging
 Increase in organized
crime
 Repealed in 1933 by
the 21st Amendment
 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)
A. True
B. False
True
False
100%
0%
 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
 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
A. Established taxes on
new drugs
B. Ensured that drugs
were proven
effective
C. Ensured that new
drugs were proven
safe
D. Enacted stiff
penalties for false
advertising
Established
taxeson
new
...
Ensured
thatdrugsw
ere...
Ensured
thatnew
drugs...
Enacted
stiffpenaltiesfor...
0% 0%
75%
25%
 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
 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
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..
0%
25%25%
50%
 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
A. True
B. False
True
False
0%0%
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
 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
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
0% 0% 0%0%0%
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
...
25%
75%
0%
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?
A. Yep, already looked
at it.
B. Yeah…heard you
say that, but where
is it?
C. No, didn’t know
that.
D. There’s an exam
tomorrow???
Yep,alreadylooked
atit.
Yeah…heard
you
saythat...
No,didn’tknow
that.
There’san
exam
tom
orr...
0% 0%0%0%
 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
A. Yes
B. No
C. Maybe in some
cases
Yes
No
M
aybe
in
som
e
cases
0% 0%0%
 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
A. True
B. False
True
False
0%0%
http://ezproxy.wwcc.edu:
2048/login?url=http://digit
al.films.com/PortalPlaylist
s.aspx?aid=7539&xtid=501
27
A. For legalization
B. Against legalization
C. For legalization,
but only for some
drugs
Forlegalization
Againstlegalization
Forlegalization,butonly...
0% 0%0%
 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
 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
 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
 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
 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
 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
 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
 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

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Goldberg Ch 4 hybrid f15

  • 1. Goldberg Chapter 4 Drugs & the Law
  • 2. A. Cat B. Dog C. Both D. Neither Cat Dog Both Neither 0% 0% 50%50%
  • 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. A. A problem best handled by the legal system B. A problem best handled as a public health issue A problem besthandled... A problem besthandled... 100% 0%
  • 7. A. Go to the future B. Go to the past C. Stay right here Go to the future Go to the past Stayrighthere 0% 0%0%
  • 8.  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
  • 9. 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... 25% 50% 0% 25%
  • 10.  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
  • 11. 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... 0% 0% 100%
  • 12.  Began with the Temperance Movement  19th Amendment passed in 1919  Speak-easies  Bootlegging  Increase in organized crime  Repealed in 1933 by the 21st Amendment
  • 13.  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)
  • 15.  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
  • 16.  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
  • 17. A. Established taxes on new drugs B. Ensured that drugs were proven effective C. Ensured that new drugs were proven safe D. Enacted stiff penalties for false advertising Established taxeson new ... Ensured thatdrugsw ere... Ensured thatnew drugs... Enacted stiffpenaltiesfor... 0% 0% 75% 25%
  • 18.  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
  • 19.  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
  • 20. 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.. 0% 25%25% 50%
  • 21.  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
  • 23. 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
  • 24.
  • 25.  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
  • 26. 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 0% 0% 0%0%0%
  • 27. 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 ... 25% 75% 0%
  • 28. 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?
  • 29. A. Yep, already looked at it. B. Yeah…heard you say that, but where is it? C. No, didn’t know that. D. There’s an exam tomorrow??? Yep,alreadylooked atit. Yeah…heard you saythat... No,didn’tknow that. There’san exam tom orr... 0% 0%0%0%
  • 30.  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
  • 31. A. Yes B. No C. Maybe in some cases Yes No M aybe in som e cases 0% 0%0%
  • 32.  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
  • 34. A. For legalization B. Against legalization C. For legalization, but only for some drugs Forlegalization Againstlegalization Forlegalization,butonly... 0% 0%0%
  • 35.  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
  • 36.  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
  • 37.
  • 38.  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
  • 39.  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
  • 40.  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
  • 41.  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
  • 42.  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
  • 43.  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

Notes de l'éditeur

  1. 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
  2. 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
  3. 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
  4. http://www.druglibrary.org/schaffer/library/studies/cu/cu8.html
  5. http://www.history.com/topics/prohibition
  6. TIMELINE: http://www.pbs.org/wgbh/pages/frontline/shows/dope/etc/cron.html
  7. 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
  8. 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
  9. http://www.pharmacytimes.com/print.php
  10. https://www.govtrack.us/congress/bills/100/hr5210#summary
  11. 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.