Chemical Dependency, Chapter 3

Whiskey Rebellion

(1790s) - 1791: Congress passed excise tax on whiskey ~ Farmers refused to pay the tax - 1794: George Washington called in the milita ~ They tried people for not paying the tax - Important historical reference for federal government being able to enforce drug laws

Opium and the Chinese

(1800s) - The Opium Wars due to China's ban on opium ~ British defeated China and signed treaty in 1842

1906 Pure Food and Drug Act

(Dept. of Agriculture) - Prohibited interstate commerce in adulterated or misbranded foods and drugs - Drug was defined as "any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease" - Basis for all modern laws regulating pharmaceuticals

Harrison (Tax) Act of 1914

(Treasury Dept) - Special tax for those dealing with opium or coca, including doctors and pharmacists - 1st step in making drugs illegal federally

The Vaccine Act of 1813

- First federal law dealing with consumer protection and therapeutic substances - Federal authority was limited mostly to imported foods and drugs

1962 Kefauver-Harris Amendments

- Had to submit plans before human testing - Drugs had to contain a summary of adverse effects possible -Drug had to be proven effective for the intended ailment

1937 Marijuana Tax Act

- Have to get special stamp for marijuana, but it has to be "in hand"-immediate violation - Deemed unconstitutional in 1970

Morphinism

- Hypodermic Syringe introduced in the US 1856 - Referred to as GOM (God's Own Medicine) - Civil War addictions: "The Army's Disease"

Cocaine

- Touted as cure for morphine addiction -Later found to be highly addictive

Patent Medicines

-Dispensed by peddlers and local stores - Bogus Claims - Ingredients not listed Ex: snake oil

Dietary Supplements

-Drug-like products that are not treated as drugs, rather treated like food - Don't need to prove effectiveness or purpose

1994 Dietary Supplement Heath and Education Act

-Expanded definition beyond vitamins, minerals and proteins, to include herbs and herbal extracts - FDA has to prove danger, rather than check quality - Cannot make direct claims, but claims of general well-being are okay

1988 Omnibus Drug Act

-Made adjustments to the Controlled Substance Act - Toughened penalties toward drug users to reduce demand - Funded treatment and education programs - Established cabinet position of National Drug Control Policy - Current director: Michael Botticelli

Interdiction

-Only 10-15% of illegal drugs supply seized annually - increased prices for street drugs due to enforcement - inability to buy illegal drugs conveniently

1965 Drug Abuse Control Amendments

-Tighter controls on amphetamines, barbiturates, hallucinogens

1882: NY State

Banned opium in Chinatown

1875 Ordinance

Banning opium smoking in San Francisco

1901

Became Bureau of Chemistry

Jones Miller Act of 1992

Doubled penalties for dealing narcotics - 1st time possession became illegal

Phase Three

Extensive study administered to large numbers (1,000-5,000) with the noted disease

Marketing a New drug

FDA established certain standards and procedures before marketing a new drug (1962) Includes 3 phases - Clinical trials take an average of 7 years

F.D.A

Grew from Harvey Wiley as the Division of Chemistry in the US Dept. of Agriculture in 1862

1982 Reagan Policy

Involves DEA, FBI, IRS, ATF, Immigration, US Marshals, Customs, Coast Guard, Defense Department

FDA

It is a scientific, regulatory, and public health agency with jurisdiction over: - most food products (other than meat and poultry) - Human and animal drugs - Therapeutic agents of biological origin - Medical devices - Cosmetics -Animal Feed

William Hearst

Links marijuana to crime in the newspapers

1912 Sherley Amendment

No false claims on the label - Response to drug claiming to cure cancer with accurate ingredient labels

1890: Federal Act

Permitting only American citizens the right to import or manufacture opium

1938 Food, Drug, and Cosmetic Act

Required toxicity testing before marketing a drug - Led to expanded role of the FDA as testers and gatekeepers of drug development

Phase One

Studies with small amounts of drug on a limited number of healthy people

Phase Two

Studying patients who have the condition that the drug is diagnosed to treat

1983 Orphan Drug Act

Tax incentives and exclusive sales rights give to develop drugs for rare diseases

Federal Food and Drug Act 1906

This added regulatory fucntions

1988 Prescription Drug Marketing Act

Tightened restrictions on "free samples"

Bureau of Narcotics

Was formed in 1930 to go after dealers, not addicts. Harry Anslinger was the commissioner ("drug czar") from 1932-1962

Comprehensive Drug Abuse Prevention and Control Act of 1970

aka Controlled Substance Act - replaced all previous laws on narcotics and dangerous substances - all drugs listed are under federal control - created new guidelines on: ~ prevention and treatment- given funding ~ control issues reassigned: All to the DEA in Dept. of Justice ~ scheduling of drugs recommended by Heath and Human Services ~penalties for possession ~ penalties for selling