More Related Content Similar to Hart13 ppt ch03 2012 (20) More from JJJulieann (15) Hart13 ppt ch03 20121. Chapter 3
Drug Products and
Their Regulations
© 2011 McGraw-Hill Higher Education. All rights reserved.
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. 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. 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. 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. 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. 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. 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.
9. Comprehensive Drug Abuse
Prevention and Control Act of 1970
Replaced or updated all previous laws
Drugs controlled by the Act are under federal
jurisdiction
Prevention and treatment funding increased
Direct control of drugs, not control through
taxation, is the goal
Enforcement separated from scientific and
medical decisions
© 2011 McGraw-Hill Higher Education. All rights reserved.
10. Comprehensive Drug Abuse
Prevention and Control Act of 1970
Drug Schedules
I – No medical use; high potential for abuse
II – Medical use; high potential for abuse
III – Medical use; moderate potential for abuse
IV – Medical use; mild potential for abuse
V – Medical use; low potential for abuse
Penalties for illegal manufacture, distribution or
possession were assigned by category
Rules for prescribing physicians
Amendments
1984
1986
1988
2010
© 2011 McGraw-Hill Higher Education. All rights reserved.
11. Impact of Drug Enforcement
Early enforcement
Prison vs. rehabilitation
Punishment seemed not to be working
“Narcotic farms”
Current issues
Bureau of Narcotics (Treasury Department)
“Drug Czar”
Mandatory minimum sentences (1951)
1956 Narcotic Drug Control Act toughened penalties
DEA formed
State vs. federal law
Drug screening
© 2011 McGraw-Hill Higher Education. All rights reserved.
12. Impact of Drug
Enforcement
Budget
Other costs
Cost of prison population
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom
Effectiveness of control?
© 2011 McGraw-Hill Higher Education. All rights reserved.
Editor's Notes 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) Image source: Fancy photographer/Veer (Image Ch03_17OpiumPoppy)