Chapter 3 Drug Products and Their Regulations Reformism Current laws trace back to two pieces of legislation from the early 1900s Fears about deviant behavior, including drug misuse, played a role in the development of drug regulation Laws were developed to regulate undesirable behaviors Issues Leading to Legislation Fraud in patent medicines that were sold directly to the public False therapeutic claims Habit-forming drug content Issues Leading to Legislation In the early 1900s, Collier?s magazine ran a series of articles attacking patent medicines: ?Great American Fraud.? 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 Issues Leading to Legislation Cocaine Present in many patent medicines Concerns about the effects of overuse grew Viewed as a cause of increasing crime 1906 Pure Food and Drugs Act Prohibited interstate commerce in adulterated or misbranded foods, drinks, and drugs Required accurate labeling and listing of ingredients Later amended to require safety testing and testing for effectiveness Harrison Act of 1914 A law that required those who produce, import, manufacture, compound, deal in, dispense, or give away opium or coca leaves (including their derivatives) to register and pay a special tax Later expanded to include other federal controlled-substance regulations Two Bureaus, Two Types of Regulation The Pure Food and Drugs Act U.S. Department of Agriculture Goal = drugs are pure and honestly labeled Harrison Act U.S. Treasury Department Goal = taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers Regulation of Pharmaceuticals 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 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 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 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 Marketing a New Drug Preclinical research and development Clinical research and development Phase One?small doses, healthy volunteers Phase Two?small number of patients w/ the condition for which the drug is designed to treat Phase Three?larger number of patients w/ the condition for which the drug is designed to treat FDA balances dangers against benefits Permission to market May require 10+ years and $800+ million Dietary Supplements 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 Controlled Substances Early enforcement 18th Amendment?prohibited alcohol; Prohibition unit established & included Narcotics Division who believed in opioid prohibition Physicians and pharmacists arrested; growth of illegal drug trade b/c users could no longer legally get drug Harsher Penalties Jones-Miller Act?more than doubled maximum penalties for dealing in illegal drugs; users became criminals Prohibition on importation of opium for heroin Controlled Substance Bureau of Narcotics (Treasury Department) Created to answer call for new approaches to dependence (?curing? rather than jailing) ?Drug Czar? began, but was not called this name Pledged to go after big dealers instead of jailing users Marijuana Tax Act passed b/c article linked marijuana w/ crime Mandatory minimum sentences 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 Attempted to balance public health concerns with law enforcement issues Drugs controlled by the act are under federal jurisdiction (Justice Department?DEA) In some cases, state and federal laws conflict Prevention and treatment Direct control of drugs, not control through taxation, is the goal Enforcement separated from scientific and medical decisions Summary of Controlled Substance Schedules Schedule Criteria Examples I High potential for abuse No accepted medical use Lack of accepted safety Heroin, marijuana, MDMA (Ecstasy) II High potential for abuse Currently accepted medical use Abuse may lead to severe dependence Morphine, cocaine, methamphetamine III Potential for abuse less than I and II Currently accepted medical use Abuse may lead to moderate physical dependence or high psychological dependence Anabolic steroids, most barbiturates IV Low potential for abuse relative to III Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to III Xanax, barbital, chloral hydrate, fenfluramine V Low potential for abuse relative to IV Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to IV Mixture with small amounts of codeine or opium Comprehensive Drug Abuse Prevention and Control Act of 1970 Possession and selling penalties Drug precursors Drug paraphernalia Office of National Drug Control Policy established It is illegal to sell drug paraphernalia; these items were seized in a raid. State and Local Regulations Difference in penalties from state to state Federal law overrides state law Significant growth in number of Americans in prison Federal Support for Drug Screening Military and federal employees People in high-risk or high-profile jobs Transportation workers Employees at private companies Public school employees Testing methods Different test = different results 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. 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 Effectiveness of Control About 10-15% 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
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