the regulation of human drugs
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The Regulation of Human Drugs. FSC-421. What is a Drug?. Section 201 (G). (A) Aricles recognized in Official Pharmacoepia (B) Articles intended for use in cure , mitigation , treatment or prevention of diseases in man

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section 201 g
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
the early days
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
history of drug regulation
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
history of drug regulation7
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
history of drug regulation8
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"
history of drug regulation9
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
history of drug regulation10
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
history of drug regulation11
History of Drug Regulation
    • required prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
history of drug regulation12
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
history of drug regulation13
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
history of drug regulation14
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
history of drug regulation15
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
controlled substances act of 1970
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
controlled substances act of 197017
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
history of drug regulation18
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
current drug regulation
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
current drug regulation20
Current Drug Regulation
  • FDA has jurisdiction over:
    • Drugs
    • Biologics
    • Medical Devices
    • Cosmetics
drugs approval process
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
tobacco regulation
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.
tobacco regulation25
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
tobacco regulation26
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"
fda agruments
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.
manufacturer s argument
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
manufacturer arguments
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
amicus briefs
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
fda vs brown williamson
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)
fda vs brown williamson32
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
  • 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