The Regulation of Human Drugs 1700 1938 What

The Regulation of Human Drugs 1700 -1938

What is a Drug?

The Simple Definition l (A) Substances recognized in Official Pharmacoepia l (B) Substances intended for use in cure, mitigation, treatment or prevention of diseases in man l (C) Substances intended to affect structure and function of body of man or animals

The History of Drug Regulation in the United States

The Early Days l 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 l 1820 -- Physicians meet in D. C. to establish U. S. Pharmacopeia, first compendium of drugs l 1848 -- The Drug Importation Act passed by Congress requires U. S. Customs Service inspection to stop the entry of “impure” drugs from overseas

History of Drug Regulation President Lincoln creates Bureau of Chemistry within USDA l 1883 -- Harvey Wiley becomes Chief Chemist in charge of “adulteration” studies and campaigns for "Pure Food and Drugs Act" l 1902 -- Biologics Control Act passed to ensure purity and safety of vaccines, serums etc. used to treat humans l 1862 --

History of Drug Regulation 1901 - Contaminated Smallpox Vaccines (New Jersey) led to a tetanus outbreak l 1902 - Contaminated diptheria vaccine (St. Louis) led to another l 1902 - Coca-Cola / cocaine controversy l Drug scares l – – "Cocaine crazed Negroes" "Reefer Madness” “Marihuana crazed Mexicans” “Opium crazed Orientals

History of Drug Regulation l New Laws – 1906 -- Pure Food and Drugs Act and Meat Inspection Act signed into law by President Roosevelt on same day l Problem: – 1911 -- U. S. v Johnson FDCA does not prohibit "false theraputic claims", only false and misleading statements about ingredients

History of Drug Regulation l 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 Regulation l 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.

History of Drug Regulation 1927 -- Bureau of Chemistry becomes Food, Drug and Insecticide Admistration l 1930 -- FDIA renamed FDA l 1938 -- Federal Food Drug and Cosmetics Act passed – Premarket approval of new drugs l