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Drug Products and
Their Regulations
© 2009 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
© 2009 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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Issues Leading to
Legislation
In the early 1900s, Collier’s
magazine ran a series of articles
attacking patent medicines—
“Great American Fraud”
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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?
© 2009 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
 Racist connections
© 2009 McGraw-Hill Higher Education. All rights reserved.
1906 Pure Food and
Drugs Act
 The Jungle
 Required accurate labeling and listing of
ingredients
 Initially, intended to protect people from
frauds, not themselves (did not limit drug
sale or purchase-still legal)
 Later amended to require safety testing
and testing for effectiveness
© 2009 McGraw-Hill Higher Education. All rights reserved.
Harrison Act of 1914
 A law that required those who “produce,
import, manufacture, compound, deal in,
dispense, or give away” cocaine and
opioids to register and pay a special tax
(think whiskey & rebellion)
 Later expanded to include other federal
controlled-substance regulations
© 2009 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
© 2009 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 – used education, not penalties,
to correct
 1912 Sherley Amendment outlawed “false
and fraudulent” therapeutic claims on labels
© 2009 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 premarket testing for toxicity following poisonings
 Companies required to submit a New Drug
Application (NDA) to the FDA
 Implication: FDA became a gatekeeper and expanded greatly
 Directions must be included
 Adequate instructions for consumer OR
 Drug can be used only with physician prescription
© 2009 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 (claim for exemption as investigational new drug
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 $800+ million
 Only 22 new drugs approved by FDA in 2007
© 2009 McGraw-Hill Higher Education. All rights reserved.
Marketing a New Drug –
more recent changes
 Orphan Drug Act, 1983—tax and other
financial incentives for drug dev’t for rare
disorders
 Prescription Drug Marketing Act of
1988—regulation of free samples, etc.
 1997 FDA Modernization Act—
guidelines for post-marketing reporting of
adverse reactions, distribution of
information on off-label uses
© 2009 McGraw-Hill Higher Education. All rights reserved.
Dietary Supplements
1994
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
(FDA must show it is unsafe –
e.g., ephedra
© 2009 McGraw-Hill Higher Education. All rights reserved.
Controlled Substances
 Early enforcement
 18th Amendment prohibiting etoh emphasized idea of
avoidance/abstinence
 Physicians and pharmacists arrested; growth of illegal
drug trade
 Stiffer penalties
 Jones-Miller Act 1922- illegal imported drugs
 Prohibition on importation of opium for heroin
 Prison vs. rehabilitation
 Punishment seemed not to be working
 “Narcotic farms”
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Controlled Substance
 Bureau of Narcotics (Treasury Department)
 “Drug Czar”
 Marijuana Tax Act in order to legally import, buy or
sell pot
 Mandatory minimum sentences (1951)
 1956 Narcotic Drug Control Act toughened penalties
 Drug Abuse Control Act Amendments of
1965
 Added new classes of drugs – speed, barbs, LSD etc
© 2009 McGraw-Hill Higher Education. All rights reserved.
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
© 2009 McGraw-Hill Higher Education. All rights reserved.
Summary of Controlled Substance Schedules
Schedule
Criteria
Examples
I
a.
b.
c.
High potential for abuse
No accepted medical use
Lack of accepted safety
Heroin,
marijuana, MDMA
(Ecstasy)
II
a.
b.
c.
High potential for abuse
Currently accepted medical use
Abuse may lead to severe dependence
Morphine,
cocaine,
methamphetamine
III
a.
b.
c.
Potential for abuse less than I and II
Currently accepted medical use
Abuse may lead to moderate physical dependence or high
psychological dependence
IV
a.
b.
c.
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
a.
b.
c.
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
© 2009 McGraw-Hill Higher Education. All rights reserved.
Anabolic steroids,
most barbiturates,
Dronabinol (THC in pill
form)
Comprehensive Drug Abuse
Prevention and Control Act of 1970
 Possession and selling
penalties
 Omnibus Drug Act
 Drug precursors
 Drug paraphernalia
 Office of National Drug
Control Policy
established – 1988
 Combat Meth Epidemic
Act - 2005
© 2009 McGraw-Hill Higher Education. All rights reserved.
It is illegal to sell drug paraphernalia;
these items were seized in a raid.
State and Local
Regulations
 Difference in
penalties from state
to state
 Federal law
overrides state law
 Significant growth
in number of
Americans in prison
© 2009 McGraw-Hill Higher Education. All rights reserved.
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
© 2009 McGraw-Hill Higher Education. All rights reserved.
Impact of Drug
Enforcement
 Budget
 International
programs
 Other federal
agencies
In this raid, an international task force seized
two tons of cocaine in the Caribbean Basin.
© 2009 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
© 2009 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
© 2009 McGraw-Hill Higher Education. All rights reserved.
Seized Ecstasy
Key Dates In American Drug,
Alcohol, and Tobacco Use
1791 Congress
Passes Excise
Tax on Whiskey
leading to
Whiskey
Rebellion
1906 Pure
Food &
Drug Act
1874
Women’s
Christian
Temperance
Union
Formed
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1914
Harrison
Act
1913
Cigarette
Brands
Introduced
Key Dates In American Drug,
Alcohol, and Tobacco Use
1954
Alcoholism
Declared a
Disease by the
American Medical
Association
First Publication
Suggests Link
Between Smoking
and Cancer
1938
Food,
Drug, &
Cosmetic
Act
1919 –
1933
Prohibition
1937
Marijuana
added to
list of
controlled
drugs
© 2009 McGraw-Hill Higher Education. All rights reserved.
1939 Alcoholics
Anonymous
Founded
Key Dates In American Drug,
Alcohol, and Tobacco Use
1964 First
Surgeon
General’s
Report to link
smoking to
health
problems
1956 Narcotic
Control Act
1960’s Low
Tar Cigarettes
Introduced
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1965
amphetamines
barbiturates, &
hallucinogens
brought under
federal control
1970
Comprehensive
Drug Abuse
Prevention and
Control Act,
National
Organization for
Reform of
Marijuana Laws
Founded,
Justice
Department
Creates the Drug
Enforcement
Agency (DEA)
Key Dates In American Drug,
Alcohol, and Tobacco Use
1973
Arizona 1st State
to restrict
smoking in
public places,
Nixon declares
War on Drugs
1988
Creation of the
Office on
National Drug
Control Policy
1982 “Just
Say No”
Campaign
Started
1977
First Great
American
Smokeout
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1987 All
States
comply with
age 21
drinking
requirement
Key Dates In American Drug,
Alcohol, and Tobacco Use
1996
Marijuana
approved for
medical use in
CA and AZ,
EPA classifies
2nd Hand
Smoke as a
Group-A
carcinogen
1991
Nicotine
Patch
Introduced
1993
Widespread
Binge
Drinking
documented
in 1st College
Alcohol Study
by Harvard
© 2009 McGraw-Hill Higher Education. All rights reserved.
1999 National Alcohol
Screening Day
Created,
Multistate Master
Tobacco Settlement
Agreement Approved,
Club Drugs get
national attention
1997
Heroin
Chic
promoted
by fashion
industry