FDA: History and Organization

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FDA History and Organization

• Edward P. RichardsHarvey A. Peltier Professor of
  LawLouisiana State University School of
  Lawrichards_at_lsu.eduhttp//biotech.law.lsu.edu
• Click Here For Updated Slides

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Colonial Efforts

• Public Health and Safety
• Central Concern
• Raked by Diseases
• Unsanitary Food
• Nuisance
• No Good Science

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An Act against selling unwholesome Provisions.

• Whereas some evilly disposed persons, from
  motives of avarice and filthy lucre, have been
  induced to sell diseased, corrupted, contagious
  or unwholesome provisions, to the great nuisance
  of public health and peace
• Be it therefore enacted by the Senate and House
  of Representatives, in General Court assembled,
  and by the authority of the same, That if any
  person shall sell any such diseased, corrupted,
  contagious or unwholesome provisions, whether for
  meat or drink, knowing the same without making it
  known to the buyer, and being thereof convicted
  before the Justices of the General Sessions of
  the Peace, in the county where such offence shall
  be committed, or the Justices of the Supreme
  Judicial Court, he shall be punished by fine,
  imprisonment, standing in the pillory, and
  binding to the good behaviour, or one or more of
  these punishments, to be inflicted according to
  the degree and aggravation of the
  offence.Massachusetts, March 8, 1785

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1800s - Era of the States

• Not Laissez-Faire
• Police Powers Were Reserved to the States
• Mostly Local, not State-Wide
• Strong Protectionist Bias
• Not Well-Suited to a National Market

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1862 - Agriculture Department

• Chemical Division
• One Chemist
• Adulterated Food
• Foods and Food Adulterants, a ten-part study
  published from 1887 to 1902
• Many Potted Meats Contained None of the Labeled
  Meat
• Many Adulterants were Dangerous

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1862 - 1940 - USDA

• 1862-1890 Chemical Division
• 1890-1901 Division of Chemistry
• 1901-1927 Food, Drug, and Insecticide
  Administration
• 1927-1930 Food and Drug Administration

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1940 - Present - FDA

• 1940-1953 Federal Security Agency
• 1953-1979 Department of Health, Education, and
  Welfare
• 1979-2002 Department of Health and Human Services

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Organization

• Executive Branch Agency
• Under the Secretary of HHS
• Senate Confirmation
• Much More of a Political Appointment than in the
  Past

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Early Laws

• The Vaccine Act of 1813
• Bad Smallpox Vaccine
• First Federal Law Dealing with Consumer
  Protection and Drugs
• Short-lived
• Biologics Act of 1902
• Passed after Deaths Due to Bad Diphtheria
  Antitoxin

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The Jungle

• Story of the Plight of Workers in the Food
  Processing Industry
• The Public was Horrified by the Food Processing,
  not the Workers
• Lead to the 1906 Act

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1906 Act

• Basic Structure of the FDA
• Followed in Broad Outline Today
• Authority over Interstate Shipment of Adulterated
  Foods and Drugs
• Narrow Use of Commerce Clause Power

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1938 Act

• Had been proposed 5 years earlier
• Pediatric Elixir Put Up In Ethylene Glycol
• Sweet and Viscous
• Deadly
• Public Outcry Lead to the Passage of the 1938 Act
• Included Cosmetics
• Broadened Definitions of Adulteration and
  Misbranding

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1962 Amendments

• Shifted from Premarket Notification to Premarket
  Approval
• Required Drugs to be Effective
• Required Reevaluation of All Marketed Drugs
• Still not Done

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MDA - 1976

• Medical Device Amendments
• Passed after Pacemaker and other Medical Device
  Scandals
• Risk Class Regulation
• New Devices Must Be Safe and Effective
• 510(k) Grandfathering
• Substantially Equivalent to a 1976 Device
• Most Devices Qualify

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Subsequent Acts

• Added User Fees to Pay for Reviews
• Reorganized FDA Functions
• Took Away Most Power over Food Supplements
• Still a Work in Progress

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Other Laws

• Biologics
• Radiation Products
• Nuclear Medicine
• X-rays
• Microwaves and Ultrasound
• Some Role in Food Service and Carriage

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Key Principles

• Regulates Products
• Must Be Interstate Commerce
• Does Not Regulate Practice of Medicine
• Docs can give what they want, as long as they do
  not ship it
• Can be regulated by the States
• Growing Free Speech Questions