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

© 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

© 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation  Fraud in patent medicines that were sold directly to the public 

© 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”

© 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 ________________  Laws passed against the importation, manufacture, and use of opium– racism involved?

© 2009 McGraw-Hill Higher Education. All rights reserved. Issues Leading to Legislation  Cocaine  Present in ________________  Viewed as a _____________________  _____________________

© 2009 McGraw-Hill Higher Education. All rights reserved Pure Food and Drugs Act  _________________________________ _________________________________ _________________________________  Later amended to _________________________________ _________________________________ _________________________________

© 2009 McGraw-Hill Higher Education. All rights reserved. Harrison Act of 1914  A law that required those who _________________________________ _________________________________ _________________________________  Later expanded to include: _________________________________ _________________________________

© 2009 McGraw-Hill Higher Education. All rights reserved. Two Bureaus, Two Types of Regulation  The Pure Food and Drugs Act (1906)  U.S. __________________________  Goal: ______________________________  Harrison Act (1914)  U.S. ___________________________  Goal:_______________________________ ___________________________________ ___________________________________ ___________________________________

© 2009 McGraw-Hill Higher Education. All rights reserved. Regulation of Pharmaceuticals 1. ___________________________ 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

© 2009 McGraw-Hill Higher Education. All rights reserved. Regulation of Pharmaceuticals 2. ____________________  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  Major implication: _________________________________  Directions must be included  Adequate instructions for consumer OR  Drug can be used only with physician prescription

© 2009 McGraw-Hill Higher Education. All rights reserved. Regulation of Pharmaceuticals 3. _______________________  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

© 2009 McGraw-Hill Higher Education. All rights reserved. Marketing a New Drug  Preclinical research and development  IND submitted to the FDA  Clinical research and development  Phase One—  Phase Two—  Phase Three—  Permission to market  May require 10+ years and $800+ million

© 2009 McGraw-Hill Higher Education. All rights reserved. Marketing a New Drug  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

© 2009 McGraw-Hill Higher Education. All rights reserved. Dietary Supplements Dietary Supplement Health and Marketing Act  Regulated______________ ______________________  Labels must be __________  Products can’t make __________________ direct claims  Products can make _______ health claims  Products can be marketed ? ______________________

© 2009 McGraw-Hill Higher Education. All rights reserved. Controlled Substances  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”

© 2009 McGraw-Hill Higher Education. All rights reserved. Controlled Substance  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  ___________________________________

© 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  ___________________________________  Prevention and treatment funding increased  ______________________________________ _____________________________________  Enforcement separated from scientific and medical decisions

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

© 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

© 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  __________________________ __________________________ __________________________

© 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.

© 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

© 2009 McGraw-Hill Higher Education. All rights reserved. Effectiveness of Control  About 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

© 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

© 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 Alcoholics Anonymous Founded 1954 Alcoholism Declared a Disease by the AMA First Publication Suggests Link Between Smoking and Cancer

© 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, and Drug Enforcement Agency (DEA) created

© 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

© 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

© 2009 McGraw-Hill Higher Education. All rights reserved. Key Dates In American Drug, Alcohol, and Tobacco Use By 2012 Twenty states legalize medical marijuana 2013 Washington and Colorado legalize marijuana