Health EDU
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ch03_2015.pptxDrug Use, Regulation, and the Law Chapter 3
Guidelines for Controlling Drug Development and Marketing
Society has the right to protect itself from the damaging impact of drug use.
Society has the right to demand safe and effective drugs.
Strategies for Preventing Drug Abuse
Supply reduction
Using drug laws to control the manufacturing and distribution of classified drugs
Inoculation
Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning
Demand reduction strategy
Aims to reduce the actual demand for drugs
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Patent Medicines
The term patent medicines signified that the ingredients were secret, not patented.
The patent medicines of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry.
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_05PatMedKentucky, Ch03_03PatMedJayne)
Issues Leading to Legislation
Cocaine
Present in many patent medicines
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_06CocaineDrops)
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_08OpiumPoster1)
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 (myth)
Laws passed against the importation, manufacture, and use of opium
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Image source: Library of Congress Prints and Photographs Division (Image Ch03_07OpiumDen)
Issues Leading to Legislation
In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines.
Drug manufacturers have a history of selling ineffective, addictive and even harmful products to the public.
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Image source: Library of Congress Prints and Photographs Division (Image Ch03_06ColliersMagazine)
1906 Pure Food and Drugs Act
Federal government law to protect the public (Dept. of Agriculture)
Required accurate labeling and listing of ingredients
US Government intervenes in commerce of adulterated or misbranded drugs and food
Misbranding only refers to the label, not advertising
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The 1906 Pure Food and Drug Act
Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product
Did not prohibit distribution of dangerous preparations
The Sherley Amendment in 1912
Accuracy of manufacturers’ therapeutic claims was not controlled by the Pure Food and Drug Act.
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.”
Food, Drug, and Cosmetic Act
The sale and use of Elixir Sulfanilamide led to a tragic accident that killed over 100 people.
Companies required to file applications with the government showing that new drugs were safe.
Food, Drug, and Cosmetic Act
A drug is a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
Before marketing, drugs must be shown to be
Safe when used as directed
Effective for their intended use
Food products and ingredients must be
Safe
Pure (unadulterated)
They are not required to show that they are effective or provide any benefit
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Food, Drug, and Cosmetic Act (continued)
Required safe tolerances be set for unavoidable poisonous substances.
Authorized establishment of identity and quality for foods.
Durham-Humphrey Amendment
Made formal distinction between prescription and nonprescription drugs
Established drug classification categories:
Drug is habit-forming
Drug is not safe for self-medication
Drug is a new drug and not shown to be completely safe
Kefauver-Harris Amendments
Passed, in part, as a consequence of the thalidomide tragedy
Drug manufacturers had to demonstrate the efficacy and safety of drugs
The FDA was empowered to withdraw approval of a drug that was already being marketed
The FDA was permitted to regulate and evaluate drug testing by pharmaceutical companies
Thalidomide Tragedy
Regulating New Drug Development
The amended Food, Drug, and Cosmetic Act requires that all new drugs be registered with and approved by the FDA.
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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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
Directions must be included
Adequate instructions for consumer OR
Drug can be used only with physician prescription
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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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Regulating New Drug Development (continued)
The FDA is mandated by Congress to:
Ensure the rights and safety of human subjects during clinical testing
Evaluate the safety and efficacy of new treatments
Compare benefits and risks of new drugs and determine if approval for marketing is appropriate
Marketing a New Drug
1) Preclinical research and development
Testing on animals (ED, LD, toxicity)
2) Clinical research and development
Phase One—small doses, healthy volunteers
Phase Two—small number of patients
Phase Three—larger number of patients
3) Permission to market (NDA)
May require 10+ years and $800+ million
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Regulatory Steps for New Prescription Drugs
Regulatory Steps for New Prescription Drugs (continued)
Step 1: Preclinical research and development
Step 2: Clinical research and development
Initial clinical stage
Clinical pharmacological evaluation stage
Extended clinical evaluation
Step 3: Permission to market
Postmarketing surveillance
New Drug Application (NDA)
If there is sufficient data to demonstrate that a drug is safe and effective, the company submits an NDA as a formal request that the FDA approve it for marketing.
Exceptions: Special Drug-Marketing Laws
“Fast-track” rule
Applied to testing of certain drugs, such as ones for rare cancers and AIDS
Orphan Drug Law
Tax advantages for development of drugs to treat “rare diseases” since this can be otherwise unprofitable
Prescription Drug User Fee Act of 1992
Increase reviewers and decrease review time
Secure and Responsible Drug Disposal Act
Addresses the problem that patients were not allowed to return drugs to DEA registrants
Prescription Drugs were legally “controlled substances” and people were not allowed to “give” it to other unauthorized people
The Regulation of Nonprescription Drugs
In 1972, the FDA initiated a program to evaluate the effectiveness and safety of nonprescription drugs.
The FDA evaluated each active ingredient in OTC medications and placed ingredients into three categories:
I. Generally recognized as safe and effective
II. Not safe and effective or unacceptable indications
III. Insufficient data to permit final classification
Switching Policy
The drug must have been used by prescription for 3 years.
Use must have been relatively high during the time it was used by prescription.
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.
Drug Advertising
Promotional efforts by pharmaceutical companies have a large impact on the drug-purchasing habits of the general public and health professionals.
As a general rule, the FDA oversees most issues related to advertising of prescription products. The FTC regulates OTC advertising.
Direct-to-Consumer (DTC) Advertising
Most physicians surveyed agreed that because their patient saw a DTC advertisement, he/she asked thoughtful questions during the visit. Approximately the same percentage of physicians thought the advertisements made their patients more aware of possible treatments.
The physicians surveyed indicated that the advertisements did not convey information about risks and benefits equally well.
Direct-to-Consumer (DTC) Advertising (continued)
Approximately 75% of physicians surveyed indicated that DTC ads cause patients to think that the drug works better than it does, and many physicians felt some pressure to prescribe something when patients mentioned DTC ads.
The physicians surveyed reported that patients understand that they need to consult a health care provider concerning appropriate treatments.
The Harrison Act of 1914
Marked the first legitimate effort by the federal government to regulate and control the production and importation of addicting substances
The Comprehensive Drug Abuse Prevention and Control Act
This 1970 act divided substances with abuse potential into categories based on the degree of their abuse potential and clinical usefulness.
Schedules I, II, III, IV, and V
“Scheduling”
Schedule I substances have high-abuse potential and no currently approved medicinal uses.
Schedule II substances have high-abuse potential but are approved for medical uses and can be prescribed.
Schedule II–V substances reflect the likelihood of abuse and clinical usefulness.
Summary of Controlled Substance Schedules
| 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 |
| 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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Factors Determining Scheduling
The actual or relative potential for abuse of the drug.
Scientific evidence of the pharmacological effects of the drug.
The state of current scientific knowledge regarding the substance.
Its history and current pattern of abuse.
What, if any, risk there is to the public health.
Factors Determining Scheduling (continued)
The psychological or physiological dependence liability of the drug.
The scope, duration, and significance of abuse.
Whether the substance is an immediate precursor of a substance already controlled.
Principal Issues Influencing Laws Regarding Substance Abuse
If a person abuses a drug, should he or she be treated as a criminal or as a sick person inflicted with a disease?
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?
Are the laws and associated penalties effective deterrents against drug use or abuse, and how is effectiveness determined?
Strategies for Preventing Drug Abuse
Supply Reduction
– Attempts to curtail the supply of illegal drugs or their precursors and exert greater control over other, more therapeutic drugs
– Includes interdiction, the policy of cutting off or destroying supplies of illicit drugs
– Limited success
Strategies for Preventing Drug Abuse (continued)
Inoculation
– Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning
Demand Reduction
– Aims to reduce the actual demand for drugs
Suggestions for Reducing Demand
A top priority of prevention is to reduce demand by youth.
Education must be carefully designed for the target population.
Attitudes toward drug abuse must be changed.
Replacement therapy can be useful.
Drug Courts
Designed to deal with nonviolent, drug-abusing offenders
Integrate mandatory drug testing, substance abuse treatment, sanctions, and incentives in a judicially supervised setting
© BrandX Pictures/Creatas
Drug Legalization Debate
Violence and crime would decrease/increase?
Profits associated with illegal trade would decrease/increase?
Law enforcement costs would decrease/increase?
Addiction would decrease/increase?
Societal/health costs would decrease/increase?
Consumption would increase/decrease?
Drug Testing
In response to the demand by society to stop the spread of drug abuse and its adverse consequences, drug testing has been implemented in some situations to detect drug users.
Breathalyzers
Urine, blood, and hair specimens
Federal Support for Drug Screening
Military and federal employees
People in high-risk or high-profile jobs
Transportation workers
Employees at private companies
Public schools employees
Testing methods
Different test = different results
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Image source: Spike Mafford/Getty Images (Image Ch03_13DrugTesting)
Pragmatic Drug Policies
The government must develop programs that are consistent with the desires of the majority of the population.
Programs must consider de-emphasizing interdiction and stress programs that reduce demand.
State and Local Regulations
Difference in penalties from state to state
Federal law overrides state law
Significant growth in number of Americans in prison
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Figure from Drugs in Depth box in text
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.
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Image source: U.S. Immigration and Customs Enforcement (Image Ch03_14InternationalDrugControl)
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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Effectiveness of Control
About 10-15% 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_15SeizedEcstasy)
Pragmatic Drug Policies (continued)
Government and society must better understand how laws, used properly and selectively, can reinforce and communicate expected social behavior and values.
Programs, such as anti-smoking campaigns, should be implemented that employ “public consensus” more effectively.
