The Regulation of Human Drugs

1. The Regulation of Human Drugs FSC-421

2. What is a Drug?

3. Section 201 (G) • (A) Aricles recognized in Official Pharmacoepia • (B) Articles intended for use in cure, mitigation, treatment or prevention of diseases in man • (C) Articles intended to affect structure and function of body of man or animals

4. The History of Drug Regulation in the United States

5. The Early Days • No Regulation • Early 1900's anything available • Any Claim could be made • Ingredient declaration not required • Opium, Cocaine, Heroin freely distributed and used in medicines

6. History of Drug Regulation • 1820 -- Physicians meet in D.C. to establish U.S. Pharmacopeia, first compendium of drugs • 1848 -- The Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop the entry of adulterated drugs from overseas

7. History of Drug Regulation • 1862 -- President Lincoln creates Bureau of Chemistry within USDA and appoints Charles Wetherill as Chief Chemist • 1883 -- Harvey Wiley becomes Chief Chemist in charge of adulteration studies and campaigns for "Pure Food and Drugs Act" • 1902 -- Biologics Control Act passed to ensure purity and safety of vaccines, serums etc. used to treat humans

8. History of Drug Regulation • 1901 - Contaminated Smallpox Vaccines (New Jersey) • 1902 - Contaminated diptheria vaccine (St. Louis) • 1902 - Coca-Cola / cocaine • Drug scares • "Cocaine crazed Negroes" • "Reefer Madness"

9. History of Drug Regulation • New Laws • 1906 --Pure Food and Drugs Act and Meat Inspection Act signed into law by President Roosevelt on same day • Problem: • 1911-- U.S. v Johnson FDCA does notprohibit "false theraputic claims", only false and misleading statements about ingredients

10. History of Drug Regulation • Response: • 1912 -- Shirley Amendments enaacted to overcome U.S. v Johnson • Legislative action required after Sup. Ct. ruling to make a change • Prohited false theraputic claims intended to defraud

11. History of Drug Regulation • 1914 -- THE HARRISON NARCOTIC ACT • required prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

12. History of Drug Regulation • 1927 -- Bureau of Chemistry becomes Food, Drug and Insecticide Admistration • 1930 -- FDIA renamed FDA • 1938 -- Federal Food Drug and Cosmetics Act passed • Premarket approval of new drugs

13. History of Drug Regulation • 1938 -- Wheeler-Lea Act requires FTC to oversee advertising of FDA products (except prescription drugs) • 1943 -- U.S. Dotterwich • 1945 -- Penicillin Amendments requires testing of safety of all penicillin products

14. History of Drug Regulation • 1950 -- Albert Foods v. U.S. - directions on label must include purpose for which drug is offered • 1951 -- Durham-Humphrey Amendment defines safe OTC vs. Prescription drugs • 1954 -- Radiological examination of foods after radioactive tuna suspected from H-bombs

15. History of Drug Regulation • 1958 -- Food Additives Amendment • Explosive growth in medical device technology • 1972 -- Labeling and safety of OTC drugs reviewed • 1976 Medical Devices Amendment • Premarket approval of devices

16. Controlled Substances Act of 1970 • Result of Nixon's war on LSD • Hippies, Timothy Leary, and Vietnam War • Created Schedules • Schedule 1 = no medical use • Heroin, Marijuana, LSD • Schedule 2 • Cocaine

17. Controlled Substances Act of 1970 • Simply move drug to higher schedule • No need for congressional acts • Harrison Act • 5 - 40 years imprisonment / 2 million fine

18. History of Drug Regulation • 1990 -- Safe Medical Devices Act • 1994 -- Dietary Supplement Health and Education Act • 1997 -- FDA Modernization Act • Accelerated review for new devices • Regulation of approved and unapproved uses of drugs • Regulation of Health Claims

19. Current Drug Regulation • FDCA requires "pre-market approval" of all new drugs • Manufacturer must demonstrate "safety and efficacy" • Animal testing studies • Post-market surveillence • GMP's

20. Current Drug Regulation • FDA has jurisdiction over: • Drugs • Biologics • Medical Devices • Cosmetics

21. How are Drugs Approved?

22. Drugs Approval Process: • Studies by manufacturer to prove safety and efficacy • Animal and Clinical tests • Investigational Exemption • Can sell limited quantities for clinical testing • New Drug Application (NDA) • Postmarket surveillance

23. The Regulation of Tobacco

24. Tobacco Regulation • FDA issued proposed regulations (ANPRM) in August 1996, finding that tobacco products were a combination of a drug and a drug delivery device • Nicotine in tobacco is a drug and sustains addiction and that cigarette makers intend its effects.

25. Tobacco Regulation • Nicotine’s widely recognized properties were foreseeable to any manufacturer (Negligence std) • Had documents suggesting that cigarette companies had long known that smokers use tobacco products to get the effects of nicotine

26. Tobacco Regulation • Major tobacco companies challenged the rules in court • Lower court judge upheld the FDA’s authority but said it could not limit advertising • 4th Circuit Court of Appeals ruled 2-1 that “FDA lacks jurisdiction to regulate tobacco products"

27. FDA Agruments: • The law allows regulation of any drug “intended” to affect the functioning of the body • Cigarette manufacturers engineer their products to deliver active doses of nicotine • Cigarette makers manipulate the content of cigarettes to promote nicotine’s effects.

28. Manufacturer's Argument: • Never suggested that people should smoke to get nicotine • Companies have no duty over uses of their products that they do not promote • FDA cannot regulate unpromoted uses of lawfully sold products

29. Manufacturer Arguments: • If FDA were to undertake regulation, it would have no choice but to ban cigarettes, because it cannot allow an unsafe product to remain on the market • Not what Congress intended under the legion of laws that regulate the tobacco industry

30. Amicus Briefs: • FDA • Public interest in protecting 3,000 children a day from becoming addicted to nicotine far outweighs the industry’s interest in avoiding regulations • Industry • Congress should decide whether tobacco products should be regulated by the FDA

31. FDA vs. Brown & Williamson • March 21, 2000 • Held: Federal government lacks authority to regulate tobacco as an addictive drug because it contains nicotine • FDA does not have jurisdiction over tobacco products (Butt Kicking)

32. FDA vs. Brown & Williamson • FDA has authority to regulate only products that are safe and effective, it cannot have authority over tobacco an inherently dangerous product • Clear that Congress never intended the FDA to have such authority

33. Summary • 1906 Pure Food and Drug Act enacted as "drug" law as much as a "food" law • Drug defined as articles intended to affect structure and function of body of man or animals • New drugs require premarket approval • Manufacturer must prove safety and efficacy • Currently, FDA has no jurisdiction over tobacco • Controlled substances regulated by schedules