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hart14_ppt_ch03.ppt© 2011 McGraw-Hill Higher Education. All rights reserved.
Chapter 3
Drug Products and
Their Regulations
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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)
© 2011 McGraw-Hill Higher Education. All rights reserved.
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
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Image source: Library of Congress Prints and Photographs Division (Image Ch03_09OpiumPoster1)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Issues Leading to Legislation
- Fraud in patent medicines that were sold directly to the public
- False therapeutic claims
- Habit-forming drug content
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Image source: Library of Congress Prints and Photographs Division (Images Ch03_06PatMedKentucky, Ch03_04PatMedJayne)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Issues Leading to Legislation
- Opium and the Chinese
- U.S. was involved in international drug trade
- Opium smoking brought to U.S. by Chinese workers
- Laws passed against the importation, manufacture, and use of opium– racism involved?
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Image source: Library of Congress Prints and Photographs Division (Image Ch03_08OpiumDen)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Issues Leading to Legislation
- Cocaine
- Present in many patent medicines (and, yes, Coca-Cola!)
- Viewed as a cause of increasing crime
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Image source: National Library of Medicine, National Institutes of Health (See image bank for Chapter 6; Image Ch06_07CocaineDrops)
© 2011 McGraw-Hill Higher Education. All rights reserved.
1906 Pure Food and Drugs Act
- Required accurate labeling and listing of ingredients
- Later amended to require safety testing and testing for effectiveness
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Harrison Act of 1914
- A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax
- Later expanded to include other federal controlled-substance regulations
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© 2011 McGraw-Hill Higher Education. All rights reserved.
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
- 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
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© 2011 McGraw-Hill Higher Education. All rights reserved.
Regulation of Pharmaceuticals
1. Purity
- The contents of the product must be accurately listed on the label
- FDA encouraged voluntary cooperation and compliance
- 1912 Sherley Amendment outlawed “false and fraudulent” therapeutic claims on labels
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© 2011 McGraw-Hill Higher Education. All rights reserved.
Regulation of Pharmaceuticals
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
FDA became a gatekeeper and expanded greatly
- Directions must be included
Adequate instructions for consumer OR
Drug can be used only with physician prescription
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© 2011 McGraw-Hill Higher Education. All rights reserved.
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
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Marketing a New Drug
- Preclinical research and development
- IND submitted to the FDA
- Clinical research and development
- Phase One—low doses, 20-80 healthy volunteers
- Phase Two—few hundred patients who could benefit
- Phase Three—typically 1,000-5,000 patients
- Permission to market
- May require 10+ years and costs $1+billion
- Only 31 new drugs approved by FDA in 2008
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Marketing a New Drug
- Orphan Drug Act—tax and other financial incentives
- Prescription Drug Marketing Act of 1988—regulation of free samples, etc.
- 1997 FDA Modernization Act—guidelines for postmarketing reporting, distribution of information on off-label uses
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Dietary Supplements
Dietary Supplement Health and Marketing Act
- Regulated more like food than drugs
- Labels must be accurate
- Products can’t make unsubstantiated direct claims
- Products can make general health claims
- Products can be marketed without first proving safety
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Image source: Image source: © The McGraw-Hill Companies, Inc./Jill Braaten, photographer (Image Ch03_12DietarySupplement)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Controlled Substance
- Bureau of Narcotics (Treasury Department)
- “Drug Czar”
- Marijuana Tax Act
- Mandatory minimum sentences (1951)
- 1956 Narcotic Drug Control Act toughened penalties
- Drug Abuse Control Act Amendments of 1965
- Added new classes of drugs
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Comprehensive Drug Abuse Prevention and Control Act of 1970
- Replaced or updated all previous laws
- Drugs controlled by the Act are under federal jurisdiction
- In some cases, state and federal laws conflict
- Prevention and treatment funding increased
- Direct control of drugs, not control through taxation, is the goal
- Enforcement separated from scientific and medical decisions
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Summary of Controlled Substance Schedules
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| Schedule | Criteria | Examples |
| I | High potential for abuse No accepted medical use Lack of accepted safety | Heroin, marijuana, MDMA (Ecstasy) |
| II | High potential for abuse Currently accepted medical use Abuse may lead to severe dependence | Morphine, cocaine, methamphetamine |
| III | Potential for abuse less than I and II Currently accepted medical use Abuse may lead to moderate physical dependence or high psychological dependence | Anabolic steroids, most barbiturates, Dronabinol (THC in pill form) |
| IV | Low potential for abuse relative to III Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to III | Xanax, barbital, chloral hydrate, fenfluramine |
| V | Low potential for abuse relative to IV Currently accepted medical use Abuse may lead to limited physical or psychological dependence relative to IV | Mixture with small amounts of codeine or opium |
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Federal Support for
Drug Screening
- Military and federal employees
- Transportation workers
- Employees at private companies
- Public schools employees
- Testing methods
- Different test = different results
- Different levels of sensitivity
- Different detection ability
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Image source: Spike Mafford/Getty Images (Image Ch03_16DrugTesting)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Impact of Drug Enforcement
- Other costs
- Cost of prison population
- Crimes committed to purchase drugs
- Corruption in law enforcement
- Conflicting international policy goals
- Loss of individual freedom
- Drug use has not been eliminated
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Image source: Fancy photographer/Veer (Image Ch03_17OpiumPoppy)
© 2011 McGraw-Hill Higher Education. All rights reserved.
Effectiveness of Control
- About 10-15 percent of illegal drug supply is seized each year
- When supplies are restricted, prices go up
- Higher prices and increased difficulty in obtaining drugs may deter some would-be users
Seized Ecstasy
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Image source: U.S. Immigration and Customs Enforcement (Image Ch03_19SeizedEcstasy)
