psy 65: chapter 3 | outines

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Chapter 3: Drug Use, Regulation, and the Law

I. Introduction

II. Cultural Attitudes About Drug Use

A. Society has the right to protect itself from the damaging impact of drug use

B. Society has the right to demand safe and effective drugs

III. The Road to Regulation and the FDA

A. Introduction

1. Patent Medicines

a. The term patent medicines signified that the ingredients were secret,

not patented

b. The patent medicines demonstrated the problems of insufficient

regulation of the drug industry

2. The 1906 Pure Food and Drug Act

a. Required manufacturers to include on labels the amounts of

alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each

product

b. The law did not allow the government to stop the distribution of

dangerous preparations

c. The Supreme Court ruled that this Act did not prohibit false therapeutic

Drugs and Society, Twelfth Edition Chapter 3: Drug Use, Regulation, and the Law

Copyright © 2015 by Jones & Bartlett Learning, LLC, an Ascend Learning Company

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claims, but only misleading and false statements about the ingredients or

identity of a drug

3. The Sherley Amendment in 1912

a. Accuracy of manufacturers’ therapeutic claims was not controlled

by the Pure Food and Drug Act

b. The Sherley Amendment in 1912 was passed to strengthen existing

laws and required that labels should not contain “any statement...regarding

the curative or therapeutic effect...which is false and fraudulent.”

B. Prescription Versus OTC Drugs

1. Food, Drug, and Cosmetic Act

a. The sale and use of Elixir Sulfanilamide led to a tragic accident

that killed over 100 people

b. Companies required to file applications with the government

showing that new drugs were safe

c. Drug label had to list all ingredients, as well as provide

instructions regarding safe use of the drug

d. Demanded that safe tolerances be set for unavoidable poisonous

substances, and authorized the establishment of standards of identity,

quality, and fill-of-container for foods

2. Durham-Humphrey Amendment

a. Made formal distinction between prescription and nonprescription drugs



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b. Required that any drug that is potentially harmful or habit-forming to be

dispensed under the supervision of a health practitioner as a prescription

drug and must carry the statement, "Caution: Federal law prohibits

dispensing without prescription.”

3. Kefauver-Harris Amendment

a. Passed, in part, as a consequence of the thalidomide tragedy

b. Drug manufacturers had to demonstrate the efficacy and safety of drugs

c. The FDA was empowered to withdraw approval of a drug that

was already being marketed

d. The FDA was permitted to regulate and evaluate drug testing by

pharmaceutical companies

C. The Rising Demand for Effectiveness in Medicinal Drugs

D. Regulating the Development of New Drugs

1. Regulatory steps for new prescription drugs

a. Step 1: Preclinical research and development

b. Step 2: Clinical research and development

i. Phase I: Initial clinical stage

ii. Phase II: Clinical pharmacological evaluation stage

iii. Phase III: Extended clinical evaluation

c. Step 3: Permission to market

2. Post-marketing surveillance

3. New Drug Application (NDA)



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a. “Fast-track” rule: Applied to testing of certain drugs for rare

cancers, AIDS, etc.

b. Orphan Drug Law: Tax advantages for development of drugs to

treat “rare diseases” since this can be otherwise unprofitable

c. Prescription Drug User Fee Act of 1992: Increase reviewers and

decrease review time

d. Secure and Responsible Drug Disposal Act

E. The Regulation of Nonprescription Drugs

1. The FDA evaluated each active ingredient in OTC medications and

placed ingredients into three categories: I. Safe and effective; II. Not safe and effective

or unacceptable indications; III. Insufficient data to permit final classification

F. The Effects of the OTC Review on Today’s Medications

1. Switching Policy

a. The drug must have been used by prescription for 3 years

b. Use must have been relatively high during the time it was used

by prescription

c. Adverse drug reactions must not be alarming, and the frequency of

side effects must not have increased during the time the drug was available

to the public

IV. The Regulation of Drug Advertising

A. Direct-to-Consumer (DTC) Advertising: Affects the patient–doctor relationship



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B. Federal Regulation and Quality Assurance

V. Drug Abuse and the Law

A. The Harrison Act of 1914

1. Marked the first legitimate effort by the federal government to regulate

and control the production, importation, etc., of addicting substances

B. The Comprehensive Drug Abuse Prevention and Control Act of 1970

1. This act divided substances with abuse potential into categories based on

the degree of their abuse potential and clinical usefulness

2. Factors Determining Scheduling determined by:

a. The actual or relative potential for abuse of the drug.

b. Scientific evidence of the pharmacological effects of the drug.

c. The state of current scientific knowledge regarding the

substance. (Criteria [2] and [3] are closely related. However, the second is

primarily concerned with pharmacological effects whereas the third deals

with all scientific knowledge with respect to the drug.)

d. Its history and current pattern of abuse.

e. What, if any, risk there is to the public health.

f. The psychological or physiological dependence liability of the drug.

g. The scope, duration, and significance of abuse.

h. Whether the substance is an immediate precursor of a substance

already controlled. The Controlled Substance Act allows inclusion of



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immediate precursors on this basis alone into the appropriate schedule, and

thus safeguards against possibilities of clandestine manufacture.

C. Drug Laws and Deterrence

1. Drug laws often do not serve as a satisfactory deterrent against the use of

illicit drugs. People have used and abused drugs for thousands of years, despite

governmental restrictions. It is very likely they will continue to do so

despite stricter laws and greater support for law enforcement.

D. Factors in Controlling Drug Abuse

1. Three principal issues influence laws regarding drug abuse, including the following:

a. If a person abuses a drug, should he or she be treated as a criminal or as a

sick person afflicted with a disease?

b. How is the user (supposedly the victim) distinguished from the pusher

(supposedly the criminal) of an illicit drug, and who should be more

harshly punished—the person who creates the demand for the drug or the person

who satisfies the demand?

c. Are the laws and associated penalties effective deterrents against drug use

or abuse, and how is effectiveness determined?

VI. Strategies for Preventing Drug Abuse

A. Supply Reduction Strategy

1. Interdiction: Decreasing the amounts of these agents that are carried

across U.S. borders by using foreign crop eradication measures and agreements,



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by imposing stiff penalties for drug trafficking, and by controlling alcoholic

beverages through licensing

B. Demand Reduction Strategy

C. Inoculation: Aims to protect drug users by teaching them responsibility

D. Drug Courts

1. Drug courts integrate mandatory drug testing, substance abuse

treatment, sanctions, and incentives in a judicially supervised setting

2. These courts hold offenders accountable for their actions and provide

them with the support and tools necessary to rebuild their lives and become

productive members of the community

VII. Current and Future Drug Use

A. Drug Legalization Debate

B. Drug Testing

1. Urine and blood testing are preferred for detecting drug use

C. Pragmatic Drug Policies

1. It is important that the government develop programs that are consistent

with the desires of the majority of the population

2. Given the difficulties and high cost of efforts to prevent illicit drugs

from reaching the market, it is logical to deemphasize interdiction and instead

stress programs that reduce demand



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3. Government and society need to better understand the role played by law

in their efforts to reduce drug addiction

4. Programs that employ “public consensus” should be implemented more

effectively to campaign against drug abuse



psy 65: chapter 3 | outines

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