1. 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

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

3. 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. 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. 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. 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. 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. 8 Organization Executive Branch Agency Under the Secretary of HHS Senate Confirmation Much More of a Political Appointment than in the Past

9. 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

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11. 11 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

12. 12 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

13. 13 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

14. 14 1962 Amendments Shifted from Premarket Notification to Premarket Approval Required Drugs to be Effective Required Reevaluation of All Marketed Drugs Still not Done

15. 15 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

16. 16 Subsequent Acts Added User Fees to Pay for Reviews Reorganized FDA Functions Took Away Most Power over Food Supplements Still a Work in Progress

17. 17 Other Laws Biologics Radiation Products Nuclear Medicine X-rays Microwaves and Ultrasound Some Role in Food Service and Carriage

18. 18 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