hart13 ppt ch03 2012 pt 1
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© 2011 McGraw-Hill Higher Education. All rights reserved.
Chapter 3Chapter 3Drug Products andTheir Regulations
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Chapter 3: Regulation & Chapter 3: Regulation & LegislationLegislation
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
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ReformismReformism
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
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© 2011 McGraw-Hill Higher Education. All rights reserved.
3 Issues Leading to 3 Issues Leading to LegislationLegislation
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
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Two Bureaus, Two TypesTwo Bureaus, Two Typesof Regulationof 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
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From 1906 Act: Regulation of From 1906 Act: Regulation of Pharmaceuticals 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
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Regulation of Regulation of PharmaceuticalsPharmaceuticals
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
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From 1914 Act: Registration & From 1914 Act: Registration & TaxationTaxation
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