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									Chapter 3
Drug Products and Their Regulations

Chapter Objectives

After reading this chapter, students should be able to:

      Discuss the role of reformist attitudes and social concerns in moving the U.S. government
       toward drug regulations.
      Understand the major purposes and influence of the 1906 Pure Food and Drugs Act.
      Understand the evolution, major purposes, and influence of the 1914 Harrison Act.
      Describe the process of approval for new pharmaceuticals.
      Describe drugs and dietary supplements as defined by the FDA.
      Describe the historical sequence of controls on opioids, cocaine, marijuana, and other
       controlled substances.
      Understand controlled substance schedules (I-V).
      Explain the impact of mandatory minimum sentencing.
      Explain what makes particular drug paraphernalia illegal.
      Compare and contrast the major types of drug testing.
      Explain how drug control efforts affect the federal budget, international relations, and the
       criminal justice systems.


Chapter Vocabulary (in order of appearance in chapter)

morphine
patent medicines
cocaine
FDA
NDA
IND
purity
effectiveness
narcotics
DEA
scheduling (drugs)
paraphernalia
“drug czar”
THC




                                                3-1
Chapter Outline

I.    The Beginnings
      A.    Reformism
            1.      Current laws trace back to two pieces of legislation from early 1900s
            2.      Racist fears about deviant behavior, including drug misuse
            3.      Laws to regulate undesirable behaviors
      B.    Issues Leading to Legislation
            1.      Patent medicines sold directly to the public
                    a.      False therapeutic claims
                    b.      Habit-forming drug content
            2.      Opium and the Chinese
                    a.      United States involved in international drug trade
                    b.      Habit of smoking opium brought to U.S. by Chinese workers
                    c.      Laws passed on importation, manufacture, and use of opium
            3.      Cocaine
                    a.      Present in many patent medicines
                    b.      Viewed as causing an increase in crime
      C.    1906 Pure Food and Drugs Act
            1.      Required accurate labeling and listing of ingredients
            2.      Later amended to require safety testing and testing for effectiveness
      D.    Harrison Act of 1914
            1.      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
            2.      Later expanded to include other federal controlled-substance regulations
      E.    Two Bureaus, Two Types of Regulation
            1.      Pure Food and Drugs Act administered by the USDA
            2.      Harrison Act administered by the U.S. Treasury Department

II.   Regulation of Pharmaceuticals
      A.     Purity
             1.      Early court cases were based on inaccurate labeling of content and claims
                     about effectiveness.
             2.      FDA encouraged voluntary cooperation and compliance.
             3.      1912 Sherley Amendment outlawed false and fraudulent therapeutic
                     claims on labels.
      B.     Safety
             1.      Originally, there were no legal requirement that medications be safe.
             2.      The 1938 Food, Drug, and Cosmetic Act required pre-market testing for
                     toxicity.
             3.      Companies are required to submit a New Drug Application (NDA) to the
                     FDA.
             4.      A label was required to give adequate directions for consumers or the drug
                     could be used only on the prescription of a physician (first distinction
                     between over-the-counter and prescription drugs).



                                             3-2
       C.     Effectiveness
              1.      Many over-the-counter medications were believed to be ineffective.
              2.      1962 Kefauver-Harris amendments
                      a.      Pre-approval is required before any human testing can be done.
                      b.      Advertising for prescription drugs must include information about
                              adverse reactions.
                      c.      Every new drug must be demonstrated to be effective for the
                              illnesses mentioned on label.
       D.     Marketing a New Drug
              1.      Drug development may require more than 10 years and cost $800 million.
              2.      Preclinical research and development
              3.      Clinical research and development (FDA involved)
                      a.      Phase One—small doses given to a small number of healthy
                              volunteers
                      b.      Phase Two—small number of patients with the condition the drug
                              is designed to treat
                      c.      Phase Three—larger number of patients with the condition the
                              drug is designed to treat
              4.      The Orphan Drug Act of 1983 provided tax incentives and special rights
                      for development of drugs for rare disorders
              5.      The Prescription Drug Marketing Act of 1988 regulated things including
                      free sample procedures.
              6.      The 1997 FDA Modernization Act included additional guidelines for
                      postmarketing reporting, distribution of information on off-label uses.
       E.     Dietary Supplements
              1.      1994 Dietary Supplement Health and Education Act
                      a.      Dietary supplements are regulated more like food than drugs.
                      b.      Labels must be accurate.
                      c.      Products can’t make unsubstantiated direct claims.
                      d.      Products can make general health claims.
                      e.      Products can be marketed without first proving safety.

III.   Controlled Substances
       A.     After the Harrison Act
              1.      Early enforcement focused on smuggling
              2.      18th Amendment prohibited alcohol
              3.      Physicians and pharmacists were arrested, resulting in the growth of the
                      illegal drug trade
              3.      Stiffer penalties
                      a.       Jones-Miller Act
                      b.       Prohibition of importation of opium for heroin
              4.      Prison vs. treatment
              5.      The Bureau of Narcotics (Treasury Department)
                      a.       “Drug czar”
                      b.       Marijuana Tax Act




                                             3-3
      B.     Narcotic Control Act of 1956
             1.     The 1951 Boggs amendment to the Harrison Act established mandatory
                    minimum sentences for drug offenses.
             2.     The 1956 Narcotic Drug Control Act toughened penalties.
      C.     Drug Abuse Control Act Amendments of 1965
             1.     New classes of drugs added
      D.     Comprehensive Drug Abuse Prevention and Control Act 1970
             1.     Replaced or updated all previous laws
             2.     Drugs controlled by the Act are under federal jurisdiction
             3.     Prevention and treatment
             4.     Control issues resolved
                    a.      Enforcement authority moved to the new DEA
                    b.      Separation of enforcement from scientific and medical decisions
             5.     Drugs classified in five sechedules
             6.     Penalties for possession made more lenient than previously
             7.     Penalties for selling became much more complex
      E.     Anti-Drug Abuse Acts of 1986 and 1988
             1.     Scheduling
                    a.      The DEA determines which drugs to schedule and at what level.
             2.     Sentencing
                    a.      The old sentencing guidelines were too complex to be useful.
                    b.      New sentencing guidelines include civil fines, forfeiture of
                            vehicles used with drugs, and loss of all federal benefits.
                    c.      Death penalty allowed for drug-related murders and drug kingpins
                    d.      Penalties on possession increased to reduce demand for drugs
             3.     Drug Precursors
                    a.      Drug precursors (raw materials that can be made intro controlled
                            substances)
             4.     Drug paraphernalia
             5.     Office of National Drug Control Policy established to better coordinate
                    federal efforts

IV.   State and Local Regulations
      A.      Difference in penalties from state to state
              1.     Federal law overrides state law

V.    Federal Support for Drug Screening
      A.     Military and Federal Employees
             1.      Military began to use random urine screening
             2.      Tests of people in various high-risk or high-profile jobs
      B.     Transportation Workers
      C.     Private Employers
      D.     Public Schools
      E.     Testing Methods




                                               3-4
VI.       The Impact of Drug Enforcement
          A.    Budget
          B.    International Programs
          C.    Other Federal Agencies
          D.    Other Costs
                1.      Cost of prisoners
                2.      Crimes committed to purchase drugs
                3.      Corruption in law enforcement
                4.      Conflicting international policy goals
                5.      Loss of individual freedom
          E.    Effectiveness of Control
                1.      About 10 to 15 percent of the illegal drug supply is seized each year.
                2.      When supplies are restricted, prices go up.
                3.      Higher prices and increased difficulty in obtaining drugs may deter some
                        would-be users.


Key Points

         Deviant behaviors associated with drugs were linked to certain races. Lawmakers used
          this to create tough drug laws.
         The moral model of addiction was the prevailing ideology of the time and addicts were
          considered weak-willed.
         Many patent medicines made great claims for curative powers but instead contained
          alcohol, cocaine, and other habit-forming drugs.
         The first drug treaty was signed into 1833 to control the international opium trade.
         A regulatory tax on imported opium was imposed in 1842. Many felt that this was a
          racist act directed against the Chinese workers, who had been brought in to help build the
          railroad system.
         Cocaine became available in the 1800s, and by the early 1900s it was widely used and
          integrated into mainstream society.
         Public concern was raised by linking sniffing cocaine to “negroes” and a rise in violent
          crime, helping build support for federal drug laws.
         The 1906 Pure Food and Drug Act centered on cleaning up the food processing plants as
          well as the labeling of food and drugs. Packages had to list the proportion of each
          ingredient but any drug could be in a product.
         The Harrison Act of 1914 came out of Dr. Hamilton Wright wanting to gain trade status
          with China. The Act, which was drafted by Wright and proposed by Senator Harrison,
          imposed a tax on all people who produce, import, manufacture, deal in, dispense, or give
          away opium or anything dealing with it. There was no penalty for possession of the drug.
          It was simply a tax law, but it was the starting point for all federal substance laws.
         The Pure Food and Drugs Act and the Harrison Act were under two very different types
          of regulation.
         With $180+ billion in sales in the U.S. alone, the pharmaceutical industry is one of the
          largest industries in the world.



                                                 3-5
   In the U.S., prescription and nonprescription drugs are subject to numerous laws that
    grew from the Pure Food and Drugs Act.
   According to the Act, which focused on foods, the percentage of each ingredient was
    monitored as were claims made about the drug.
   The 1912 Sherley Amendment made “false and fraudulent” clams illegal.
   Due to deaths from untested drugs, the 1938 Food, Drug and Cosmetics Act was passed.
    This Act turned the FDA from tester to gatekeeper. From this point forward, drug
    companies had to test the drugs first and show that the drugs were safe before they could
    market them. Companies now had to put safe directions on the bottles to show how the
    drug should be taken. Drugs were also separated into two categories: prescription and
    over-the-counter.
   The 1962 Kefauver-Harris amendments added to the law that, among other things, a drug
    had to show effectiveness and the company had to get approval before any tests on
    humans were done. Companies were also required to include adverse reactions of taking
    the drug in all advertisements.
   The process of getting a new drug on the market now takes over 10 years and costs over
    $800 million according to pharmaceutical companies. The FDA is involved only at the
    end of the process when the company wants to do testing on humans, after preliminary
    laboratory and animal tests have indicated that the drug is safe and effective.
   Three phases in clinical research and development of a drug:
     Phase one: low dose study on a small number of healthy people
     Phase two: a few hundred patients who have the condition that the new drug might
        help
     Phase three: much larger study from 1,000 to 5,000 patients who have the condition
        that the new drug might help
   The 1997 FDA Modernization Act added a step that is sometimes called “phase four”
    because it called for drug companies to continue to inform about adverse effects that are
    found out after a drug is approved.
   The Modernization Act also let companies tell physicians about other uses for the same
    drug, so-called off-label uses. For example, if a drug is approved for heart disease
    prevention but then later found to help prevent stroke in some people, the company can
    help cross-market the drug even if there is not as much research on the second use.
   The Orphan Drug Act offered tax relief and selling rights for companies who developed
    drugs for rare disorders that affect no more than 200,000 people.
   The Prescription Drug Marketing Act of 1988 set more rules for the way doctors hand out
    free samples. In addition, it addressed how counterfeit drugs find their way into the U.S.
   Dietary supplements are regulated more like foods than drugs are. They do not have to
    go through the three-phase testing system nor do they have to be proven effective.
    However, they do have to be labeled accurately.
   The 1994 Dietary Supplement Health and Education Act widened the definition of
    supplements to include vitamins, mineral, herbs, and herbal extracts. The Act bans
    unproven claims on labels.
   The FDA can pull a supplement from the market only after it is proven unsafe
    (e.g., ephedra).
   In the early 1900s, drug control focused on narcotics, so the people sent to enforce drug
    laws were officers of the narcotic division of the Treasury Department. Most narcotic


                                           3-6
    officers went after physicians who prescribed drugs over the phone without seeing the
    patients, much like Internet doctors do now.
   With the 18th Amendment, U.S. drug laws became about stopping access to drugs or
    alcohol. The IRS closed many clinics across the country, and the crackdown on
    physicians and pharmacists caused legal access to morphine and other opioids to dry up.
   This in turn led to a huge growth in black market opioids at a very high cost. People
    dependent on opioids started to look like a societal/criminal problem more than a medical
    one.
   Stiffer penalties began following the 1922 Jones-Miller Act, which made drug possession
    a crime and more than doubled the maximum penalties for dealing.
   As morphine and opium became more expensive, heroin became a popular alternative.
    Heroin was soon added to the list of illegal drugs.
   In 1929, Congress tried to deal with the growing number of prisoners jailed for drug
    offences with “narcotic farms.” These treatment centers were for prisoners dependent on
    drugs who were in jail for a federal offense.
   In 1932, with Harry Anslinger in charge, the Bureau of Narcotics was set up within the
    FBI.
   Marijuana came under the same legal control as cocaine and opiates with the Marijuana
    Control Act of 1937; it was listed as a narcotic from 1937 to1970.
   In the 1960s, the drug of choice changed, as did the typical user. Mood and
    consciousness altering drugs became popular with well-educated users.
   The 1965 Drug Abuse Control amendments placed mood and consciousness altering
    drugs in the same class as opioids, cocaine, and marijuana. Additional changes came
    when the Bureau of Narcotics became the Bureau of Narcotics and Dangerous Drugs.
   The Comprehensive Drug Abuse Prevention and Control Act of 1970 replaced or updated
    all federal laws related to narcotics and other drugs. Federal drug laws now supersede
    state drug laws; direct control of drugs rather than control through taxation is the focus of
    drug laws.
   The DEA in the Justice Department was the new enforcer, while scientific decisions were
    under the Department of Health and Human Services.
   Drug schedules were set up (see Table 3.1). The major difference among the different
    categories is that Schedule I drugs are classified as having no medical value.
   Penalties for selling or dealing the drugs got stiffer and were based on the schedule of the
    drug in question. This differed from possession penalties, which were reduced and did
    not depend on the drug schedule.
   In 1986, amendments were added to include crack cocaine. These amendments also
    established that lower quantities had higher penalties.
   The 1988 Omnibus Act, among other things, allowed the death penalty for any murder
    that happened in conjunction with a drug-related felony. The Act funded treatment and
    education programs. Drug paraphernalia and precursor chemicals were added to the list
    of controlled items.
   The U.S. military led the way with random urine testing. Soon other high-risk
    professions followed, and now many large companies require a drug test before
    extending an employment offer. Even public high schools can test for all types of drugs.




                                             3-7
      Testing methods include not only urine tests but hair and saliva analysis as well as others.
       There are advantages and disadvantages for each type of test.
      Money spent on drug regulation goes up every year; we are now looking at $12.6 billion
       for 2005.


Chapter Discussion Questions and Activities

Ask students to research your state’s drug laws. How do they differ from federal laws? You can
have a police officer or an attorney or DA come talk to the class about the laws and punishment.

Describe the FDA approval process for developing new drugs. What are the advantages and
disadvantages of the process? How could it be changed? How important is time in the process?

List and explain the main arguments for and against legalizing drugs.

With the “war on drugs” declared by U.S. government, what has and has not been accomplished?

What is your opinion about compulsory drug testing in the workplace? List three positive and
three negative aspects of such testing.

As individuals or in groups, students are given an island and instructed that they are the new
government. Ask the new governments to answer the following questions: What type of drug
laws would they have? How would they deal with drug abuse, misuse, and dependence
problems? What would penalties be for crimes committed for drugs or under the influence of
drugs? Would there be an age limit or minimum for drug use? If so, what would be the
penalties for underage usage or possession or sales to minors? What are some problems that
might come up with the laws?


Suggested Videos

Drugs and Punishment: Are America’s Drug Policies Fair?
Films for the Humanities and Sciences
http://www.films.com/id/9558

Altered States: A History of Drug Use in America
Films for the Humanities and Sciences
http://www.films.com/id/8215




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