The Regulation of Human Drugs

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The Regulation of Human Drugs

• FSC-421

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What is a Drug?
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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

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The History of Drug Regulation in the United
States
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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

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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

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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

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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"

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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 not prohibit
  "false theraputic claims", only false and
  misleading statements about ingredients

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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Current Drug Regulation

• FDA has jurisdiction over
• Drugs
• Biologics
• Medical Devices
• Cosmetics

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How are Drugs Approved?
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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

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The Regulation of Tobacco
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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.

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Tobacco Regulation

• Nicotines 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

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Tobacco Regulation

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

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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 nicotines effects.

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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

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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

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Amicus Briefs

• FDA
• Public interest in protecting 3,000 children a
  day from becoming addicted to nicotine far
  outweighs the industrys interest in avoiding
  regulations
• Industry
• Congress should decide whether tobacco
  products should be regulated by the FDA

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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)

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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

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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