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FDA: History and Organization

FDA: History and Organization . Edward P. Richards Harvey A. Peltier Professor of Law Louisiana State University School of Law richards@lsu.edu http://biotech.law.lsu.edu Click Here For Updated Slides. Colonial Efforts. Public Health and Safety Central Concern Raked by Diseases

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FDA: History and Organization

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  1. FDA: History and Organization Edward P. RichardsHarvey A. Peltier Professor of LawLouisiana State University School of Lawrichards@lsu.eduhttp://biotech.law.lsu.edu Click Here For Updated Slides

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 1940 - Present - FDA • 1940-1953 Federal Security Agency • 1953-1979 Department of Health, Education, and Welfare • 1979-2002 Department of Health and Human Services

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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 1962 Amendments • Shifted from Premarket Notification to Premarket Approval • Required Drugs to be Effective • Required Reevaluation of All Marketed Drugs • Still not Done

  14. 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

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

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

  17. 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

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