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Chapter 3Chapter 3Drug Products andTheir Regulations

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Chapter 3: Regulation & Chapter 3: Regulation & LegislationLegislation

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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ReformismReformism

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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3 Issues Leading to 3 Issues Leading to LegislationLegislation

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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Two Bureaus, Two TypesTwo Bureaus, Two Typesof Regulationof 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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From 1906 Act: Regulation of From 1906 Act: Regulation of Pharmaceuticals 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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Regulation of Regulation of PharmaceuticalsPharmaceuticals

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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From 1914 Act: Registration & From 1914 Act: Registration & TaxationTaxation

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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Comprehensive Drug Abuse Comprehensive Drug Abuse

Prevention and Control Act of 1970Prevention 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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Comprehensive Drug Abuse Comprehensive Drug Abuse

Prevention and Control Act of 1970Prevention 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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Impact of Drug EnforcementImpact 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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Impact of Drug Impact of Drug EnforcementEnforcement

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?