Chapter 3
Drug Policy
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Two Classes of Drug Laws
Regulation of “legal” drugs for:
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pharmaceutical companies
pharmacists
physicians
others who manufacture and dispense them
Criminalization of certain drugs for their:
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use
possession
sales
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Beginnings of Regulation
Issues leading to legislation
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Widespread legal distribution of patent medicines
Concerns about drug abuse being associated with morality
Three pieces of legislation inform current drug laws
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1906 Pure Food and Drugs Act
1914 Harrison Act
18th Amendment, Alcohol Prohibition in 1918
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Issues Leading to Legislation, 1
Fraud in patent medicines sold directly to the public
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False therapeutic claims
Habit-forming drug content
Source: Library of Congress Prints and Photographs
Division [LC-USZ62-9194]
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Issues Leading to Legislation, 2
Opium
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The United States signed its first treaty to control international opium
trade in 1833
Laws passed against the importation, manufacture,
and use of opium were:
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Issues Leading to Legislation, 3
Cocaine
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Was present in products such as:
• Patent medicines and tonics
• Coca-Cola
Source: National Library of Medicine
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1906 Pure Food and Drugs Act
Prohibited interstate commerce in misbranded and
adulterated foods and drugs
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Misbranding referred only to labeling and not advertising
Specifically referred to alcohol, morphine, opium,
cocaine, heroin, Cannabis indica, and other agents
Protected people from unscrupulous merchants, not
from themselves
Provided the basis on which all modern laws
regulating pharmaceuticals have been grafted
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Harrison Act of 1914
Required those who “produce, import, manufacture,
compound, deal in, dispense, or give away” certain
drugs to register and pay a special tax
Initially controlled opium and cocaine
Later expanded to include other federal controlledsubstance regulations
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Two Types of Regulation
The Pure Food and Drugs Act, 1906
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Administered within the United States Department of Agriculture
Goal: to ensure that drugs are pure and honestly labeled
Harrison Act, 1914
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Administered by the United States Treasury Department
Goal: taxation of drugs to restrict commerce in opioids and cocaine to
authorized physicians, pharmacists, and legitimate manufacturers
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Regulation of Pharmaceuticals, 1
Purity
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1906 Pure Food and Drugs Act
• Product contents must be accurately listed on the label
From its beginning, Food and Drug Administration or F D A has
encouraged voluntary cooperation rather than forced compliance
1912 Sherley Amendment outlawed “false and fraudulent” therapeutic
claims on labels
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Regulation of Pharmaceuticals, 2
Safety
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1906 Pure Food and Drugs Act had no legal requirement that medicines
be safe
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1938 Food, Drug, and Cosmetic Act
• Required premarket testing of new drugs for toxicity
• F D A became a gatekeeper
• Companies were required to submit a New Drug Application or N D A
• Reduced the likelihood of new drugs being introduced by small
companies run by untrained people
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Directions that must be included
• Adequate instructions for consumer
• Statement that the drug can be used only upon a physician’s
prescription
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Regulation of Pharmaceuticals, 3
Effectiveness
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1938 Food, Drug, and Cosmetic Act
• No legal requirement that medications be effective
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1962 Kefauver-Harris Amendments
• Required approval for human testing before clinical trials begin
• Advertising for prescription drugs must include information about
adverse reactions
• Every new drug must be demonstrated to be effective for the
illnesses mentioned on the label
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Process for Introducing a New Drug
Preclinical research and development
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Company submits a “Notice of Claimed Investigational Exemption for a
New Drug” or I N D to the F D A
Company also submits all preclinical investigations, including effects of
drug on animals
Clinical research and development
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Phase One: How the drug is absorbed and excreted
• Who is tested: 20 to 80 healthy volunteers who are given low doses
Phase Two: Initial effectiveness testing
• Who is tested: a few hundred patients who could benefit
Phase Three: Broader effectiveness testing
• Who is tested: typically 1,000 to 5,000 patients
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Dietary Supplements
1994 Dietary Supplement Health and Education Act
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Labels must be accurate
Products can’t make unsubstantiated direct claims
Products can make general health claims
©McGraw-Hill Education/Jill Braaten, photographer
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Legislation of Controlled Substances, 3
Comprehensive Drug Abuse Prevention and Control
Act of 1970
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Replaced or updated all previous laws
• In some cases, state and federal laws conflict
Part of the law gave increased funding for:
• Research, treatment, and prevention efforts by Department of
Health and Human Services
Established direct control over drugs by Drug Enforcement
Administration or D E A
• Taxation was no longer a strategy
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Controlled Substance Schedules, 1
Schedule
Criteria
Schedule 1
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Schedule 2
Schedule 3
High potential for abuse
No currently acceptable medical use in treatment
in the United States
Lack of accepted safety for use under medical
supervision
Examples
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Heroin
Marijuana
M D M A or Ecstasy
• High potential for abuse
• Currently accepted medical use
• Abuse may lead to severe psychological or
physical dependence
• Morphine
• Cocaine
• Methamphetamine
• Potential for abuse less than 1 and 2
• Currently accepted medical use
• Abuse may lead to moderate physical
dependence or high psychological
dependence
• Anabolic steroids
• Most barbiturates
• Dronabinol or T H C
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Controlled Substance Schedules, 2
Schedule
Criteria
Examples
Schedule 4
• Low potential for abuse relative to 3
• Currently accepted medical use
• Abuse may lead to limited physical or
psychological dependence relative to 3
• Alprazolam or
Xanax
• Fenfluramine
• Zolpidem or
Ambien
Schedule 5
• Low potential for abuse relative to 4
• Currently accepted medical use
• Abuse may lead to limited physical or
psychological dependence relative to 4
• Mixtures having
small amounts of
codeine or opium
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Federal Support for Drug Screening
Examples of tested populations
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Military and federal employees
Transportation workers
Employees at private companies
Students in public schools
Testing method issues
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Different tests equal different results
Rate of false-positive results, which indicate drug use when the person
did not actually take the drug being tested for
Some tests detect the presence of drugs, but they do not tell anything
about the state of impairment of the individual at the time of the test
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Impact of Drug Enforcement, 1
Budget
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Less than 1 billion dollars in 1980
27.6 billion dollars in 2016
International programs
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D E A has agents in over 40 countries
Uruguay recently legalized marijuana
• United Nations has criticized the Uruguay government for
international treaty violations
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Impact of Drug Enforcement, 2
Other federal agencies involved in drugcontrol efforts
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Department of Homeland Security
Federal Aviation Administration
National Park Service, Department of Agriculture, and Bureau of Land
Management
Other costs
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Maintaining prisons and caring for prisoners
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom
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Effectiveness of Control
Approximately 10 to 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 users
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