Hart13 ppt ch03 2012 pt 1

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  • Image sources: National Library of Medicine (Image Ch03_01CocaWine) Library of Congress Prints and Photographs Division (Image Ch03_02PatMedHoofland) PhotoLink/Getty Images (Image Ch03_11DrugDevelopment)
  • Image source: Library of Congress Prints and Photographs Division (Image Ch03_09OpiumPoster1)
  • Image source: Library of Congress Prints and Photographs Division (Image Ch03_09OpiumPoster1)
  • Image source: Library of Congress Prints and Photographs Division (Images Ch03_06PatMedKentucky, Ch03_04PatMedJayne)
  • Hart13 ppt ch03 2012 pt 1

    1. 1. Chapter 3 Drug Products and Their Regulations© 2011 McGraw-Hill Higher Education. All rights reserved.
    2. 2. Chapter 3: Regulation & Legislation  What is being targeted?  Certain substances  Recreational use  Medicinal use  Who is doing the regulating?  U.S. Department of Agriculture/FDA  U.S. Treasury Department  Motives  Public safety concerns?  Revenue & trade status?  Impact© 2011 McGraw-Hill Higher Education. All rights reserved.
    3. 3. Reformism  Current laws trace back to two pieces of legislation from the early 1900s  Racist fears about deviant behavior, including drug misuse, played a role in the development of drug regulation  Laws were developed to regulate undesirable behaviors© 2011 McGraw-Hill Higher Education. All rights reserved.
    4. 4. 3 Issues Leading to Legislation  Fraud in patent medicines that were sold directly to the public  False therapeutic claims  Habit-forming drug content  Collier’s magazine series: Great American Fraud  Opium  Sale of opium by merchants  Reactions  Cocaine  Availability led to concerns of overuse  Concerns of crime© 2011 McGraw-Hill Higher Education. All rights reserved.
    5. 5. Two Bureaus, Two Types of Regulation  The Pure Food and Drugs Act (1906)  U.S. Department of Agriculture  Goal: drugs are pure and honestly labeled  Foundation for modern laws  Harrison Act (1914)  U.S. Treasury Department  Goal: taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers  Question of motives© 2011 McGraw-Hill Higher Education. All rights reserved.
    6. 6. From 1906 Act: Regulation of Pharmaceuticals 1. Purity  The contents of the product must be accurately listed on the label  FDA encouraged voluntary cooperation and compliance 2. Safety  Originally—no legal requirement that medications be safe  1938 Food, Drug, and Cosmetic Act required pre-market testing for toxicity  Companies required to submit a New Drug Application (NDA) to the FDA  Directions must be included  Adequate instructions for consumer OR  Drug can be used only with physician prescription© 2011 McGraw-Hill Higher Education. All rights reserved.
    7. 7. Regulation of Pharmaceuticals 3. Effectiveness  1962 Kefauver-Harris Amendments  Pre-approval required before human testing  Advertising for prescription drugs must include information about adverse reactions  Every new drug must be demonstrated to be effective for the illnesses mentioned on label  Steps  Preclinical research and development  Clinical research and development  Permission to market© 2011 McGraw-Hill Higher Education. All rights reserved.
    8. 8. From 1914 Act: Registration & Taxation  Early enforcement  Dr. Webb  1919 Volstead act & Bureau of Prohibition  Prohibited sale of alcohol  Penalties for production  18th Amendment: Prohibition – 1920  Repealed in 1933 by the 21st Amendment© 2011 McGraw-Hill Higher Education. All rights reserved.

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