This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict regulatory system continue to be debated.

1. Chapter 3
Drug Products and
Their Regulations
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2. Chapter 3: Regulation &
Legislation
 What is being targeted?
 Certain substances
 Recreational use
 Medicinal use
 Who is doing the regulating?
 U.S. Department of Agriculture/FDA
 U.S. Treasury Department
 Motives
 Public safety concerns?
 Revenue & trade status?
 Impact
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3. Reformism
 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
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4. 3 Issues Leading to
Legislation
 Fraud in patent medicines that were
sold directly to the public
 False therapeutic claims
 Habit-forming drug content
 Collier’s magazine series: Great
American Fraud
 Opium
 Sale of opium by merchants
 Reactions
 Cocaine
 Availability led to concerns of overuse
 Concerns of crime
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5. Two Bureaus, Two Types
of Regulation
 The Pure Food and Drugs Act (1906)
 U.S. Department of Agriculture
 Goal: drugs are pure and honestly labeled
 Foundation for modern laws
 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
 Question of motives
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6. From 1906 Act: Regulation of
Pharmaceuticals
1. Purity
 The contents of the product must be accurately listed on the label
 FDA encouraged voluntary cooperation and compliance
2. 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
 Directions must be included
 Adequate instructions for consumer OR
 Drug can be used only with physician prescription
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7. Regulation of
Pharmaceuticals
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
 Steps
 Preclinical research and development
 Clinical research and development
 Permission to market
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8. From 1914 Act: Registration &
Taxation
 Early enforcement
 Dr. Webb
 1919 Volstead act & Bureau of Prohibition
 Prohibited sale of alcohol
 Penalties for production
 18th Amendment: Prohibition – 1920
 Repealed in 1933 by the 21st Amendment
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9. Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Replaced or updated all previous laws
 Drugs controlled by the Act are under federal
jurisdiction
 Prevention and treatment funding increased
 Direct control of drugs, not control through
taxation, is the goal
 Enforcement separated from scientific and
medical decisions
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10. Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Drug Schedules
 I – No medical use; high potential for abuse
 II – Medical use; high potential for abuse
 III – Medical use; moderate potential for abuse
 IV – Medical use; mild potential for abuse
 V – Medical use; low potential for abuse
 Penalties for illegal manufacture, distribution or
possession were assigned by category
 Rules for prescribing physicians
 Amendments
 1984
 1986
 1988
 2010
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11. Impact of Drug Enforcement
 Early enforcement
 Prison vs. rehabilitation
 Punishment seemed not to be working
 “Narcotic farms”
 Current issues
 Bureau of Narcotics (Treasury Department)
 “Drug Czar”
 Mandatory minimum sentences (1951)
 1956 Narcotic Drug Control Act toughened penalties
 DEA formed
 State vs. federal law
 Drug screening
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12. Impact of Drug
Enforcement
 Budget
 Other costs
 Cost of prison population
 Crimes committed to purchase drugs
 Corruption in law enforcement
 Conflicting international policy goals
 Loss of individual freedom
 Effectiveness of control?
© 2011 McGraw-Hill Higher Education. All rights reserved.