Two Classes of Drug LawsBeginnings of RegulationIssues Leading to Legislation1906 Pure Food and Drug ActHarrison Act of 1914Two Types of RegulationRegulation of PharmaceuticalsProcess for Introducing a New DrugAdditional FDA LegislationDietary SupplementsLegislation of Controlled SubstancesControlled Substances SchedulesState and Local RegulationsFederal Support for Drug ScreeningImpact of Drug EnforcementEffectiveness of ControlDrug Policy Two Classes of Drug Laws- Regulation of “legal” drugs pharmaceutical companies pharmacists physicians all others who manufacture and dispense- Criminalization of certain drugs use possession salesBeginnings of Regulation- Issues leading to legislation Fraud (patent medicines) Morality and race (drugs of abuse)- 3 pieces of legislation inform current drug laws 1906 Pure Food and Drugs Act 1914 Harrison Act 18th Amendment (Alcohol Prohibition: 1918)Issues Leading to Legislation- Fraud in patent medicines sold directly to the public False therapeutic claims Habit-forming drug content- Opium Opium smoking brought to U.S. by Chinese workers U.S. was involved in international drug trade- Laws passed against the importation, manufacture, and use of opium Role of racism- Cocaine Present in products:o Patent medicineso Coca-Cola- Viewed as a cause of increasing crime Role of racism1906 Pure Food and Drug Act- Purpose of the legislation Prohibited interstate commerce in misbranded and adulterated food and drugs Misbranding referred only to labeling not advertising- Later amendments for: Testing for safety Testing for effectivenessHarrison Act of 1914- Purpose of the legislation required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax Initially controlled opium and cocaine- Later expanded to include other federal controlled-substance regulationsTwo 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 manufacturersRegulation of Pharmaceuticals- Purity 1906 Pure Food and Drug Act:o Product contents must be accurately listed on the label Initially, FDA encouraged voluntary cooperation and compliance  1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels- Safety 1906 Pure Food and Drug Act:o No legal requirement that medications be safe  1938 Food, Drug, and Cosmetic Act:o FDA became a gatekeeper and expanded greatlyo Required pre-market testing for toxicityo Companies required to submit a New Drug Application (NDA) Directions must be included:o Adequate instructions for consumer oro Drug can be used only with physician prescription- Effectiveness 1938 Food, Drug, and Cosmetic Act:o No legal requirement that medications be effective 1962 Kefauver-Harris Amendments:o Pre-approval required before human testingo Advertising for prescription drugs must include information about adverse reactionso Every new drug must be demonstrated to be effective for the illnesses mentioned on labelProcess for Introducing a New Drug- Preclinical research and development Company submits “Notice of Claimed Investigational Exemption for a New Drug” (IND)- Clinical research and developmentPhaseTesting Who is tested1 How the drug is absorbed and excreted low doses, 20-80 healthy volunteers2 Initial effectiveness testing A few hundred patients who could benefit3 Broader effectiveness testing typically 1,000-5,000 patientsAdditional FDA Legislation- Orphan Drug Act (1983) Developing drugs for rare disorders Tax and other financial incentives - Prescription Drug Marketing Act of 1988 Regulation of free samples to physicians- 1997 FDA Modernization Act Guidelines for:o postmarketing reporting of adverse effectso distribution of information on off-label usesDietary Supplements- 1994 Dietary Supplement Health and Marketing Act Labels must be accurate Products can’t make unsubstantiated direct claims Products can make general health claims Products can be marketed without first proving safetyLegislation of Controlled Substances- Early enforcement 1914 Harrison Acto Narcotics Division’s interpretation of Act led to criminalization of drug useo Physicians and pharmacists arrested 18th Amendment (Alcohol Prohibition: 1918)- Jones-Miller Act of 1922 Doubled the penalties for dealing in illegal drugs- Prison vs. rehabilitation Congress deemed punishment ineffective Established “Narcotic farms” for rehabilitation (1935)- Bureau of Narcotics Formed in 1930 in the Treasury Department Harry Anslinger (first “Drug Czar”) Instrumental in passing the Marijuana Tax Act (1937)- 1956 Narcotic Drug Control Act Toughest penalties to date- 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 jurisdictiono In some cases, state and federal laws conflict- Increased funding for: Prevention and treatment (Department of Heath and Human Services) Direct control of drugs (Drug Enforcement Agency)o Taxation was no longer a strategy- Enforcement separated from scientific and medical decisions- Amendments to Comprehensive Drug Abuse Prevention and Control Act of 1970 1986o Stiffened possession and selling penaltieso Crack vs powder cocaine sentencing 1988o Control of drug precursorso Control of drug paraphernaliao Established the Office of National Drug Control PolicyControlled Substances SchedulesScheduleCriteria ExamplesI a. High potential for abuseb. No accepted medical usec. Lack of accepted safetyHeroin,marijuana, MDMA (Ecstasy)II a. High potential for abuseb. Currently accepted medical usec. Abuse may lead to severe dependenceMorphine,cocaine, methamphetamineIII a. Potential for abuse less than I and IIb. Currently accepted medical usec. Abuse may lead to moderate physical dependence or high psychological dependenceAnabolic steroids, most barbiturates,Dronabinol (THC in pill form)IV a. Low potential for abuse relative to IIIb. Currently accepted medical usec. Abuse may lead to limited