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Chapter 3

Drug Policy

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Two Classes of Drug Laws

Regulation of “legal” drugs

pharmaceutical companies

pharmacists

physicians

all others who manufacture and dispense

Criminalization of certain drugs

use

possession

sales

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Beginnings of Regulation

Issues leading to legislation

Fraud (patent medicines)

Morality and race (drugs of abuse)

3 pieces of legislation inform current drug laws

1906 Pure Food and Drugs Act

1914 Harrison Act

18th Amendment (Alcohol Prohibition: 1918)

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Image source: Library of Congress Prints and Photographs Division (Image Ch03_09OpiumPoster1)

Fraud in patent medicines sold directly to the public

False therapeutic claims

Habit-forming drug content

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Issues Leading to Legislation

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Opium

Opium smoking brought to U.S. by Chinese workers

U.S. was involved in international drug trade

Laws passed against the importation, manufacture, and use of opium

Role of racism

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Issues Leading to Legislation

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Image Source: Library of Congress Prints and Photographs Division

Cocaine

Present in products:

Patent medicines

Coca-Cola

Viewed as a cause of increasing crime

Role of racism

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Issues Leading to Legislation

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Image Source: National Library of Medicine

Purpose of the legislation

Prohibited interstate commerce in misbranded and adulterated food and drugs

Misbranding referred only to labeling not advertising

Later amendments for:

Testing for safety

Testing for effectiveness

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1906 Pure Food and Drug Act

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Harrison Act of 1914

Purpose of the legislation

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 controlled-substance regulations

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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

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Two Types of Regulation

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Purity

1906 Pure Food and Drug Act:

Product contents must be accurately listed on the label

Initially, FDA encouraged voluntary cooperation and compliance

1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels

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Regulation of Pharmaceuticals

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Safety

1906 Pure Food and Drug Act:

No legal requirement that medications be safe

1938 Food, Drug, and Cosmetic Act:

FDA became a gatekeeper and expanded greatly

Required pre-market testing for toxicity

Companies required to submit a New Drug Application (NDA)

Directions must be included:

Adequate instructions for consumer or

Drug can be used only with physician prescription

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Regulation of Pharmaceuticals

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Effectiveness

1938 Food, Drug, and Cosmetic Act:

No legal requirement that medications be effective

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

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Regulation of Pharmaceuticals

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Preclinical research and development

Company submits “Notice of Claimed Investigational Exemption for a New Drug” (IND)

Clinical research and development

Phase One: How the drug is absorbed and excreted

Who is tested: low doses, 20-80 healthy volunteers

Phase Two: Initial effectiveness testing

Who is tested: a few hundred patients who could benefit

Phase Three: Broader effectiveness testing

Who is tested: typically 1,000-5,000 patients

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Process for Introducing a New Drug

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Orphan Drug Act (1983)

Developing drugs for rare disorders

Tax and other financial incentives

Prescription Drug Marketing Act of 1988

Regulation of free samples to physicians

1997 FDA Modernization Act

Guidelines for:

postmarketing reporting of adverse effects

distribution of information on off-label uses

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Additional FDA Legislation

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1994 Dietary Supplement Health and Marketing Act

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

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Dietary Supplements

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Image source: Image source: © The McGraw-Hill Companies, Inc./Jill Braaten, photographer

Early enforcement

1914 Harrison Act

Narcotics Division’s interpretation of Act led to criminalization of drug use

Physicians and pharmacists arrested

18th Amendment (Alcohol Prohibition: 1918)

Jones-Miller Act of 1922

Doubled the penalties for dealing in illegal drugs

Prison vs. rehabilitation

Congress deemed punishment ineffective

Established “Narcotic farms” for rehabilitation (1935)

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Legislation of Controlled Substances

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Bureau of Narcotics

Formed in 1930 in the Treasury Department

Harry Anslinger (first “Drug Czar”)

Instrumental in passing the Marijuana Tax Act (1937)

1956 Narcotic Drug Control Act

Toughest penalties to date

Drug Abuse Control Act Amendments of 1965

Added new classes of drugs

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Legislation of Controlled Substances

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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

Increased funding for:

Prevention and treatment (Department of Heath and Human Services)

Direct control of drugs (Drug Enforcement Agency)

Taxation was no longer a strategy

Enforcement separated from scientific and medical decisions

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Legislation of Controlled Substances

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Controlled Substance Schedules

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Schedule	Criteria	Examples
I	High potential for abuse No accepted medical use Lack of accepted safety	Heroin, marijuana, MDMA (Ecstasy)
II	High potential for abuse Currently accepted medical use Abuse may lead to severe dependence	Morphine, cocaine, methamphetamine
III	Potential for abuse less than I and II Currently accepted medical use Abuse may lead to moderate physical dependence or high psychological dependence	Anabolic steroids, most barbiturates, Dronabinol (THC in pill form)
IV	Low potential for abuse relative to III Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to III	Xanax, barbital, chloral hydrate, fenfluramine
V	Low potential for abuse relative to IV Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to IV	Mixture with small amounts of codeine or opium

Amendments to Comprehensive Drug Abuse Prevention and Control Act of 1970

1986

Stiffened possession and selling penalties

Crack vs powder cocaine sentencing

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Legislation of Controlled Substances

1988

Control of drug precursors

Control of drug paraphernalia

Established the Office of National Drug Control Policy

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Penalties differ from state to state

Federal law overrides state law

Significant growth in number of Americans in prison

Increased awareness of high incarceration rate has recently led to a decline in prison population

But U.S. still has greatest proportion of citizens in prison compared to other countries

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State and Local Regulations

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Figure from Drugs in Depth box in text

Examples of tested populations:

Military and federal employees

Transportation workers

Employees at private companies

Public schools employees

Testing method issues

Different test = different results

Different levels of sensitivity

Different detection ability

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Federal Support for Drug Screening

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Budget

$1 billion in 1980

$25.6 billion in 2013

International programs

DEA has agents in over 40 countries

Uruguay recently legalized marijuana

United Nations has criticized government for treaty violations

Other federal agencies

Homeland Security

Federal Aviation Administration

National Park Service

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Impact of Drug Enforcement

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Other costs

Maintaining prisons and caring for prisoners

Crimes committed to purchase drugs

Corruption in law enforcement

Conflicting international policy goals

Loss of individual freedom

Drug use has not been eliminated

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Impact Of Drug Enforcement

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Approximately 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 users

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Effectiveness of Control

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