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Soc 204 goldberg ch 4
This document discusses the history of drug regulation in the United States from the 18th century to present day. Early attempts focused on alcohol and opium, establishing taxes and restrictions. The 20th century saw the passage of laws regulating proprietary drugs, narcotics, and the creation of the FDA. Modern drug laws classify substances by schedule and aim to balance public health and criminal enforcement, though debates continue around decriminalization and legalization.
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Soc 204 goldberg ch 4
- 1. Goldberg Chapter 4Drugs & the Law
- 2. A. Cat B. Dog C.Both D. Neither Cat Dog Both Neither 14% 5% 14% 68%
- 4. A. Fabulous B. Meh C.Don’t even ask Fabulous M eh Don’teven ask 40% 12% 48%
- 5. Attempts havebeen made to regulate the use of mind- altering substances since settlers first arrived in the New World The first substance regulated was alcohol The temperance movement in the late 1700s advocated that people become more educated about the hazards of alcohol Click picture for video
- 6. Alcohol 1791:Congress passed an excise tax on whiskey Opium 1833: US treaty regulated international opium trade 1842:Tax on crude opium shipped to the US 1875: San Francisco prohibiting smoking in opium dens 1890: Only US citizens could manufacture or import opium Proprietary drugs (over-the-counter drugs) Pure Food and Drug Act of 1906
- 7. Do druglaws affect whether people use drugs? Should drug laws be aimed at drug users, sellers, or traffickers? Should the role of government be to inform its citizens about drugs or to prevent its citizens from using drugs? Should a person be prevented from engaging in self-destructive behavior?
- 8. A. A problembest handled by the legal system B. A problem best handled as a public health issue A problem besthandled... A problem besthandled... 75% 25%
- 9. Before 1906,patent medicines were largely unregulated US Food and Drug Administration (FDA) was created to assess drug hazards and prohibit sale of dangerous drugs Law required drug manufacturers to report adverse reactions to their products Law required that the amount or proportion of drugs in the medicine had to be listed on the label
- 10. A. Stop peoplefrom using opium B. Establish taxes on drugs C. Force people to get prescriptions for drugs D. Keep dangerous drugs off the market Stop peoplefrom using... Establish taxeson drugs Force peopleto getpresc... Keep dangerousdrugsoff... 0% 88% 4%8%
- 11. The HarrisonAct resulted from the need to limit opiate use Law governed the marketing and sale of narcotics, regulated nonmedical narcotic use, and made possession of narcotics without a prescription illegal Doctors and pharmacists had to keep records of the prescriptions they wrote To obtain drugs, an increasing number of people resorted to criminal activity
- 12. A. Established taxes ondrugs B. Made opium illegal without a prescription C. Established jail time for drug offenses Established taxeson drugs M ade opium illegalw ith... Established jailtim e for... 4% 0% 96%
- 13. Began withthe Temperance Movement 19th Amendment passed in 1919 Speak-easies Bootlegging Increase in organized crime Repealed in 1933 by the 21st Amendment
- 14. Forbade therecreational use of marijuana, but not medicinal or industrial uses Anyone using marijuana was required to pay a tax – failure to comply meant a large fine or prison term for tax evasion AMA and others opposed marijuana legislation The Federal Bureau of Narcotics, established in 1932, later became the Drug Enforcement Administration (DEA)
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- 16. Under 1906guidelines, a drug manufacturer could not be prosecuted for fatalities due to toxic drugs 1938 Act required pharmaceutical companies to file applications with the federal government demonstrating that all new drugs were safe and properly labeled Manufacturers had to submit a “new drug application” to the FDA, giving the FDA more authority and responsibility
- 17. Did notcover drugs that were previously marketed Drugs had to be proven safe, but not effective Government had little authority to enact penalties Manufacturers determined whether a drug would be sold as a prescription or over-the-counter Manufacturers conducted their own tests to determine a drug’s effectiveness
- 18. A. Established taxeson new drugs B. Ensured that drugs were proven effective C. Ensured that new drugs were proven safe D. Enacted stiff penalties for false advertising Established taxeson new ... Ensured thatdrugsw ere... Ensured thatnew drugs... Enacted stiffpenaltiesfor... 0% 4% 96% 0%
- 19. Serious birthdefects caused by thalidomide resulted in implementation of stronger regulations regarding drug testing Kefauver-Harris Amendments, 1962, gave the FDA the authority to withdraw drugs from the marketplace Drug advertisements directed to physicians were required to include the drug’s side effects and its contraindicated uses Testing procedures required prior approval from the FDA
- 20. 1972 DrugEfficacy Study:The FDA asked the National Research Council to conduct a study of new drugs Active ingredients were placed in one of three categories: Category I drugs: Determined to be safe, effective, and properly labeled Category II drugs: Not generally recognized as safe and effective, or recognized as mislabeled; must be removed from medications within six months Category III drugs: Data insufficient to determine general recognition of safety and effectiveness
- 21. A. The FDAhad the authority to remove unsafe drugs from the market B. Taxes on drug advertisements were enacted C. Advertisements must include side-effects D. Tests were required prior to a drug’s approval TheFDA had theauthorit... Taxeson drugadvertise... Advertisem entsm ustinc... Testsw ererequired prior.. 0% 0% 8% 92%
- 22. Comprehensive DrugAbuse Prevention and Control Act (Controlled Substances Act), effectively replaced all previous laws dealing with narcotics and dangerous drugs Expanded community health centers and Public Health Service hospitals for drug abusers Established a commission on marijuana and drug abuse Divided drugs into five categories called schedules
- 23.
- 24. Schedule Criteria Examples Ia. High potential for abuse b. No accepted medical use c. Lack of accepted safety Heroin, marijuana, MDMA (Ecstasy) II a. High potential for abuse b. Currently accepted medical use c. Abuse may lead to severe dependence Morphine, cocaine, methamphetamine III a. Potential for abuse less than I and II b. Currently accepted medical use c. Abuse may lead to moderate physical dependence or high psychological dependence Anabolic steroids, most barbiturates, Dronabinol (THC in pill form) IV a. Low potential for abuse relative to III b. Currently accepted medical use c. Abuse may lead to limited physical or psychological dependence relative to III Xanax, barbital, chloral hydrate, fenfluramine V a. Low potential for abuse relative to IV b. Currently accepted medical use c. Abuse may lead to limited physical or psychological dependence relative to IV Mixture with small amounts of codeine or opium
- 26. Legislation thatemphasizes stringent punishment of the drug user, to reduce drug demand Punishment could be waived if the user completes a drug rehabilitation program Greatly increased federal prison population and led to a new Cabinet position, Director of National Drug Control Policy Under this law, drug users are punished more stringently than rapists or robbers
- 27. A. Emphasized strict punishmentfor drug infractions B. Allowed offenders to complete treatment rather than jail C. Created lighter sentences for drug offenses D. A & B E. All of the above Em phasized strictpunis... Allow ed offendersto co... Created lightersentences... A & B Alloftheabove 8% 0% 8% 84% 0%
- 28. A. Absolutely. B. No,I disagree, it was a bad idea. C. I’m not sure or have no opinion. Absolutely. No,Idisagree,itw asab.. I’m notsure orhaveno ... 100% 0%0%
- 29. 1. Should thesale of drug paraphernalia be illegal? 2. Should people using small amounts of illegal drugs for personal enjoyment receive harsh criminal penalties? 3. What are the advantages and disadvantages of decriminalizing or legalizing drugs? 4. What impact has drug enforcement had on drug use? 5. Should the vast amount of money spent on stopping drugs be used differently?
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- 31. A. Yep, alreadylooked at it. B. Yeah…heard you say that, but where is it? C. No, didn’t know that. D. There’s an exam tomorrow??? Yep,alreadylooked atit. Yeah…heard you saythat... No,didn’tknow that. There’san exam tom orr... 0% 0%0%0%
- 32. Drug paraphernalia: Items that are aids to using drugs (cigarette- rolling papers, water pipes, razors, clay pipes, roach clips, spoons, mirrors, and other products) Prosecuting individuals for possessing drug paraphernalia is viewed as a deterrent for drug use
- 33. In 1988,Congress proclaimed that the US would be drug-free by 1995 The monetary expense and human resources employed to combat illicit drug use are enormous – yet, the number of Americans who have used illegal drugs has increased The government’s assault on illicit drugs has resulted in social tension, ill health, violent crime, compromised civil liberties, and international conflict
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- 35. A. For legalization B.Against legalization C. For legalization, but only for some drugs Forlegalization Againstlegalization Forlegalization,butonly... 0% 0%0%
- 36. Some arguethat decriminalization would increase drug use, addiction, and drug- related deaths Drug-related crimes might fall, but the number of addicts would rise Legalization would result in more dysfunctional addicts who would be unable to support their lifestyles and drug use through legitimate means
- 37. Legal regulationof drugs would protect drug takers and save money Billions of dollars spent on drug enforcement might be put to use more effectively if the money were directed toward education and treatment programs
- 39. Drug enforcementis designed to stem the flow of drugs coming into the US and to punish the user To stop drugs at their source, the State Department works with a number of foreign governments DEA agents help block drugs from leaving other countries, eradicate crops, and find and dismantle illegal laboratories
- 40. Farmers makemore money from coca or opium crops than from legal crops On a global scale, less than 10% of illegal crops are consistently eradicated Interdiction is especially difficult because of numerous points of entry
- 41. Harm reduction Interventions that respond to needs of drug users and the community to reduce harm caused by illicit drug use Includes providing sterile syringes to reduce spread of HIV infection, education, and increased treatment Treats drug abuse as a public health problem, not a criminal problem
- 42. Normalization Termused by the Dutch for the practice of not prosecuting users of soft drugs such as marijuana Using some drugs is not illegal, but drug traffic is illegal Treatment assists physical and social well-being of addicts rather than try to stop their addiction Result: Netherlands has less drug use than the US and other European countries
- 43. Questionable searchwarrants in inner-city communities People of color are stopped and searched more often than others on the basis of “drug courier” profiles Despite comparable drug usage, Blacks are incarcerated at a higher rate thanWhites Penalties for crack cocaine, used more by poor, are greater than those for powder cocaine, used more by middle class
- 44. Starting in1984, Congress enacted mandatory minimum penalties specifically focusing on drugs and violent crimes It has been shown that mandatory minimum drug sentences have not acted as deterrents to further crime Mandatory minimum drug sentences give no latitude to judges to determine appropriate punishments Treatment is 15 times more effective for reducing serious crime than mandatory minimum sentencing
Editor's Notes
- #7 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 Fraud in patent medicines that were sold directly to the public False therapeutic claims Habit-forming drug content In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines— “Great American Fraud” Opium and the Chinese U.S. was involved in international drug trade Opium smoking brought to U.S. by Chinese workers Laws passed against the importation, manufacture, and use of opium– racism involved? Cocaine Present in many patent medicines (and, yes, Coca-Cola!) Viewed as a cause of increasing crime Racist connections
- #8 Required accurate labeling and listing of ingredients Later amended to require safety testing and testing for effectiveness A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax Later expanded to include other federal controlled-substance regulations 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
- #11 1. Purity The contents of the product must be accurately listed on the label FDA encouraged voluntary cooperation and compliance 1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels 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 FDA became a gatekeeper and expanded greatly Directions must be included Adequate instructions for consumer OR Drug can be used only with physician prescription 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
- #13 http://www.druglibrary.org/schaffer/library/studies/cu/cu8.html
- #15 http://www.history.com/topics/prohibition
- #16 TIMELINE: http://www.pbs.org/wgbh/pages/frontline/shows/dope/etc/cron.html
- #18 DIETARY SUPPLEMENTS Regulated more like food than drugs 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 Early enforcement 18th Amendment Physicians and pharmacists arrested; growth of illegal drug trade Stiffer penalties Jones-Miller Act Prohibition on importation of opium for heroin Prison vs. rehabilitation Punishment seemed not to be working “Narcotic farms” Bureau of Narcotics (Treasury Department) “Drug Czar” Marijuana Tax Act Mandatory minimum sentences (1951) 1956 Narcotic Drug Control Act toughened penalties Drug Abuse Control Act Amendments of 1965 Added new classes of drugs 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 Prevention and treatment funding increased Direct control of drugs, not control through taxation, is the goal Enforcement separated from scientific and medical decisions Possession and selling penalties Omnibus Drug Act Drug precursors Drug paraphernalia Office of National Drug Control Policy established
- #19 Preclinical research and development IND submitted to the FDA Clinical research and development Phase One—low doses, 20-80 healthy volunteers Phase Two—few hundred patients who could benefit Phase Three—typically 1,000-5,000 patients Permission to market May require 10+ years and costs $1+billion Only 31 new drugs approved by FDA in 2008 Orphan Drug Act—tax and other financial incentives Prescription Drug Marketing Act of 1988—regulation of free samples, etc. 1997 FDA Modernization Act—guidelines for postmarketing reporting, distribution of information on off-label uses
- #24 http://www.pharmacytimes.com/print.php
- #28 https://www.govtrack.us/congress/bills/100/hr5210#summary
- #36 Budget International programs Other federal agencies Other costs Cost of prison population Crimes committed to purchase drugs Corruption in law enforcement Conflicting international policy goals Loss of individual freedom Drug use has not been eliminated About 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 would-be users Difference in penalties from state to state Federal law overrides state law Significant growth in number of Americans in prison In 2007 the number rose to 5.06 prisoners per thousand and in 2008 it dropped slightly to 5.04 per thousand.