1. © 2009 McGraw-Hill Higher Education. All rights reserved. Drug Products and Their Regulations

2. © 2009 McGraw-Hill Higher Education. All rights reserved. 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

3. © 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation  Fraud in patent medicines that were sold directly to the public  False therapeutic claims  Habit-forming drug content

4. © 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines— “Great American Fraud”

5. © 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation  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?

6. © 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation  Cocaine  Present in many patent medicines (and, yes, Coca-Cola!)  Viewed as a cause of increasing crime  Racist connections

7. © 2009 McGraw-Hill Higher Education. All rights reserved. 1906 Pure Food and Drugs Act  The Jungle  Required accurate labeling and listing of ingredients  Initially, intended to protect people from frauds, not themselves (did not limit drug sale or purchase-still legal)  Later amended to require safety testing and testing for effectiveness

8. © 2009 McGraw-Hill Higher Education. All rights reserved. Harrison Act of 1914  A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” cocaine and opioids to register and pay a special tax (think whiskey & rebellion)  Later expanded to include other federal controlled-substance regulations

9. © 2009 McGraw-Hill Higher Education. All rights reserved. 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  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

10. © 2009 McGraw-Hill Higher Education. All rights reserved. Regulation of Pharmaceuticals 1. Purity  The contents of the product must be accurately listed on the label  FDA encouraged voluntary cooperation and compliance – used education, not penalties, to correct  1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels

11. © 2009 McGraw-Hill Higher Education. All rights reserved. Regulation of Pharmaceuticals 2. Safety  Originally—no legal requirement that medications be safe  1938 Food, Drug, and Cosmetic Act required pre- market testing for toxicity following poisonings  Companies required to submit a New Drug Application (NDA) to the FDA  Implication: FDA became a gatekeeper and expanded greatly  Directions must be included  Adequate instructions for consumer OR  Drug can be used only with physician prescription

12. © 2009 McGraw-Hill Higher Education. All rights reserved. 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

13. © 2009 McGraw-Hill Higher Education. All rights reserved. Marketing a New Drug  Preclinical research and development  IND (claim for exemption as investigational new drug 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 $800+ million  Only 22 new drugs approved by FDA in 2007

14. © 2009 McGraw-Hill Higher Education. All rights reserved. Marketing a New Drug – more recent changes  Orphan Drug Act, 1983—tax and other financial incentives for drug dev’t for rare disorders  Prescription Drug Marketing Act of 1988—regulation of free samples, etc.  1997 FDA Modernization Act— guidelines for post-marketing reporting of adverse reactions, distribution of information on off-label uses

15. © 2009 McGraw-Hill Higher Education. All rights reserved. Dietary Supplements 1994 Dietary Supplement Health and Marketing Act  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 (FDA must show it is unsafe – e.g., ephedra

16. © 2009 McGraw-Hill Higher Education. All rights reserved. Controlled Substances  Early enforcement  18th Amendment prohibiting etoh emphasized idea of avoidance/abstinence  Physicians and pharmacists arrested; growth of illegal drug trade  Stiffer penalties  Jones-Miller Act 1922- illegal imported drugs  Prohibition on importation of opium for heroin  Prison vs. rehabilitation  Punishment seemed not to be working  “Narcotic farms”

17. © 2009 McGraw-Hill Higher Education. All rights reserved. Controlled Substance  Bureau of Narcotics (Treasury Department)  “Drug Czar”  Marijuana Tax Act in order to legally import, buy or sell pot  Mandatory minimum sentences (1951)  1956 Narcotic Drug Control Act toughened penalties  Drug Abuse Control Act Amendments of 1965  Added new classes of drugs – speed, barbs, LSD etc

18. © 2009 McGraw-Hill Higher Education. All rights reserved. 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

19. Summary of Controlled Substance Schedules ScheduleCriteriaExamples Ia.High potential for abuse b.No accepted medical use c.Lack of accepted safety Heroin, marijuana, MDMA (Ecstasy) IIa.High potential for abuse b.Currently accepted medical use c.Abuse may lead to severe dependence Morphine, cocaine, methamphetamine IIIa.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) IVa.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 Va.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 © 2009 McGraw-Hill Higher Education. All rights reserved.

20. Comprehensive Drug Abuse Prevention and Control Act of 1970  Possession and selling penalties  Omnibus Drug Act  Drug precursors  Drug paraphernalia  Office of National Drug Control Policy established – 1988  Combat Meth Epidemic Act - 2005 It is illegal to sell drug paraphernalia; these items were seized in a raid.

21. © 2009 McGraw-Hill Higher Education. All rights reserved. State and Local Regulations  Difference in penalties from state to state  Federal law overrides state law  Significant growth in number of Americans in prison

22. © 2009 McGraw-Hill Higher Education. All rights reserved. Federal Support for Drug Screening  Military and federal employees  Transportation workers  Employees at private companies  Public schools employees  Testing methods  Different test = different results  Different levels of sensitivity  Different detection ability

23. © 2009 McGraw-Hill Higher Education. All rights reserved. Impact of Drug Enforcement  Budget  International programs  Other federal agencies In this raid, an international task force seized two tons of cocaine in the Caribbean Basin.

24. © 2009 McGraw-Hill Higher Education. All rights reserved. Impact of Drug Enforcement  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

25. © 2009 McGraw-Hill Higher Education. All rights reserved. Effectiveness of Control  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 Seized Ecstasy

26. © 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use 1791 Congress Passes Excise Tax on Whiskey leading to Whiskey Rebellion 1874 Women’s Christian Temperance Union Formed 1906 Pure Food & Drug Act 1913 Cigarette Brands Introduced 1914 Harrison Act

27. © 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use 1919 – 1933 Prohibition 1937 Marijuana added to list of controlled drugs 1938 Food, Drug, & Cosmetic Act 1939 - Alcoholics Anonymous Founded 1954 Alcoholism Declared a Disease by the American Medical Association First Publication Suggests Link Between Smoking and Cancer

28. © 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use 1956 Narcotic Control Act 1960’s Low Tar Cigarettes Introduced 1964 First Surgeon General’s Report to link smoking to health problems 1965 amphetamines barbiturates, & hallucinogens brought under federal control 1970 Comprehensive Drug Abuse Prevention and Control Act, National Organization for Reform of Marijuana Laws Founded, Justice Department Creates the Drug Enforcement Agency (DEA)

29. © 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use 1973 Arizona 1 st State to restrict smoking in public places, Nixon declares War on Drugs 1977 First Great American Smokeout 1982 “Just Say No” Campaign Started 1987 All States comply with age 21 drinking requirement 1988 Creation of the Office on National Drug Control Policy

30. © 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use 1991 Nicotine Patch Introduced 1993 Widespread Binge Drinking documented in 1 st College Alcohol Study by Harvard 1996 Marijuana approved for medical use in CA and AZ, EPA classifies 2 nd Hand Smoke as a Group-A carcinogen 1997 Heroin Chic promoted by fashion industry 1999 National Alcohol Screening Day Created, Multistate Master Tobacco Settlement Agreement Approved, Club Drugs get national attention