CHAPTER 3 DRUG REGULATION, DEVELOPMENT, NAMES, AND INFORMATION

I. Landmark Drug Legislation

A. FEDERAL PURE FOOD AND DRUG ACT OF 1906 – only requirement was that drugs be
free of adulterants
1912 – Shirley Amendment
1914 – narcotics and habit forming drugs sales were regulated

B. FOOD, DRUG AND COSMETIC ACT OF 1938 – Congress required that all new drugs
undergo testing for toxicity
- results of testing were to be reviewed by the Food and Drug
Administration (FDA)
- only those drugs judged to be safe would receive FDA approval for
marketing

C. HARRIS-KEFAUVER AMENDMENTS (TO THE FOOD, DRUG AND COSMETIC ACT) OF 1962 –
sought to strengthen all
aspects of drug regulation
- major provisions was to require proof of effectiveness before a new drug
could be marketed
- established rigorous procedures for testing new drugs

D. CONTROLLED SUBSTANCES ACT (TITLE II OF THE COMPREHENSIVE DRUG ABUSE PREVENTION AND
CONTROL ACT)
OF 1970 – set rules for the manufacture and distribution of drugs considered to
have potential for abuse
- Schedule I = have no accepted medical use in the United States and are
deemed to have a high potential for abuse
ex. Heroin, mescaline, and lysergic acid diethylamide (LSD)
- Schedules II through V = have accepted medical applications but also
have the potential for abuse

E. FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 – called for widespread
changes in FDA
regulations
1. Fast track system created for AIDS drugs and cancer drugs now includes
drugs for other serious and
life threatening illnesses.
2. Manufacturers must inform patients at least 6 months in advance of
stopping the production of a drug,
giving them time to find another source of the drug.
3. FDA can now require drug companies to test drugs in children.
4. Clinical trial database will be established for drugs directed at serious or
life-threatening illnesses.
5. Drug companies can now give physicians journal articles and certain other
information regarding “off-
label” uses of drugs.
 Off-label – a use that has not been evaluated by the FDA

PRE-TEST ? Which one of the drug acts established the first enforcing agency to
monitor drugs:
Drug Orphan Act of 1938

PRE-TEST ? Which one of the following drugs is considered a Schedule III drug:
Codeine

PRE-TEST ? Before drugs can be tested on humans, what must be obtained:

Investigational new drug permit

II. NEW DRUG DEVELOPMENT

A. RANDOMIZED CONTROLLED TRIAL (RCT)

- most reliable way to objectively assess drug therapies
- used to evaluate all new drugs

1. Distinguishing Features
a. Use of Controls – how a drug compares with a standard drug used
for the same disorder, or
perhaps how it compares with no treatment at all
- subjects in the RCT are given the new drug and some are
given either standard
treatment or a placebo

controls – subjects receiving either the standard drug or

the placebo

b. Randomization – subjects are randomly assigned to either the

control group or the experiment
group
- purpose is to prevent allocation bias, which results when
subjects in the experimental
group are different from those in the control group
c. Blinding – a study in which the people involved do not know to
which group – control or
experimental- individual subjects have been randomized.
- done to minimize the impact of personal bias

Single blind – only the subjects have been “blinded”

Double blind – both the subjects and the researchers have
been kept in the dark
(most objective)

B. STAGES OF NEW DRUG DEVELOPMENT

 1. Preclinical Testing – required before a new drug may be tested in
humans
- drugs are evaluated for toxicity, pharmacokinetic properties, and
potentially useful biologic
effects

2. Clinical Testing
a. Phase I – usually conducted in normal volunteers
- two goals: evaluation of drug metabolism
determination of effects in humans
b. Phases II and III – tested in patients
- objective is to determine therapeutic effects, dosage range,
and safety
c. Phase IV – new drug is released for general use, permitting
observation of its effects in a large
population

C. LIMITATIONS OF TESTING PROCEDURE

1. Information on drug use in women and children has been limited.
- women of child-bearing age were excluded from early clinical trials
- only women allowed to participate in early clinical trials were those
with a life-threatening
illness that might respond to the drug under study
- data generated since the implementation of the new guidelines
have been reassuring:
most gender effects have been limited to pharmacokinetics,
and more importantly,
for most drugs, gender has shown little impact on efficacy,
safety, or dosage
- children, like women, had been excluded from clinical trials of
drugs

2. New drugs are likely to have adverse effects that were note detected
during clinical trials.
- testing procedures cannot detect all adverse effects before a new
drug is released because:
- during clinical trials a relatively small number of patients are
given the drug
- because patients are carefully selected, they do not
represent the full spectrum of
individuals who will eventually take the drug
- patients in trials take the drug for a relatively short time
- because of unavoidable limitations in the testing process, effects
that occur infrequently, take
a ling time to develop, and/or occur in certain types of patients
may go undetected

D. EXERCISING DISCRETION REGARDING NEW DRUGS

- Be neither the first to adopt the new nor the last to abandon the old
 - when weighing the benefit of a new drug against its risks, it is likely that
the benefits will be insufficient
to justify the risks – especially when an older drug, whose properties
are well known, would
probably provide adequate treatment.
- it is usually better to adopt a wait and see policy, letting more
adventurous clinicians discover the
hidden dangers that a new drug may harbor

III. DRUG NAMES

- discussion includes defining the types of names that drugs have
- consider the complications that arise from assigning multiple names to a
drug and the benefits of using
just one name: the generic (nonproprietary) name

A. THREE TYPES OF DRUG NAMES

1. Chemical Name – constitutes a description of a drug using the
nomenclature of chemistry

2. Generic Name – generic names are assigned by the United States

Adopted Names Council
- each drug has only one generic name
- also know as the nonproprietary name

3. Trade Name – also known as proprietary or brand names

- names under which a drug is marketed - must be
approved by FDS
- tries to ensure that no two trade names are too similar

B. WHICH NAME TO USE: GENERIC OR TRADE?

- drug names are employed in two ways: - for written and oral
communication about medicines
- for labeling medication containers
(accurate communication
is imperative in regard to compound)

1. Generic Name Problems

- generic names are longer and more complicated than its trade
name
- generic names can be more difficult to remember and pronounce
- pharmaceutical industry has an important role in establishing
generic names and it is to the
company’s advantage to have a product whose trade name is
more easily recognized
than its generic name; it seems unlikely that a company will
suggest a simple,
euphonious generic name

2. Trade Name Problems

 a. Single Drug can have Multiple Trade Names – principal
objection to trade names is their
vast number
- although a drug can have only one generic name, it can have
unlimited trade names
- using multiple trade names does nothing but create
confusion
- clouding communication about drugs, use of trade names
can result in “double
medication” with potentially disastrous results

b. Same Trade Name can be used for Different Products –

products that have very similar
trade names can actually contain very different drugs
- manufacturers can reformulate brand-name products
whenever they want – without
changing the name at all
- no guarantee that the brand-name product bought today
contains the same drug as
did the brand-name product bought last week, last
month, or last year

3. Drug Marketing – why do we use trade names at all? Because the

pharmaceutical industry wants
them.
- trade names give this industry a unique and powerful tool with
which to market its products
- consumers will be loyal to their product not because that product is
better or cheaper than
someone else’s, but because product labeling with trade
names makes it very difficult to identify the competition so
that comparisons can be made
- since a drug cannot be identified by looking at it, consumers
cannot escape reliance on
package labeling to inform them about the medicine inside
- identification can be marketed under a system that employs
multiple trade names,
thereby making product identification needlessly and
dangerously difficult

4. Generic Products vs. Brand-Name Products

Do significant differences exist between different brands of the same
drug?
If such differences do exist, do they justify the use of trade names?

The answer to both questions is NO.

a. Are Generic Products and Brand-Name Products

Therapeutically Equivalent?
 - generic and bran name products contain the same dose of
the same drug, the only
concern with generic formulations is the rate and extent
of their absorption
- it is reasonable to conclude that all FDA approved generic
products are
therapeutically equivalent to their brand name
counterparts
b. Would a Difference Between Brand-Name and Generic
Products Justify the Use of Trade
Names?
- even if generic formulations were significantly different from
brand name formulations,
this would not justify using trade names to identify
preferred products.

5. Conclusion Regarding Generic Names and Trade Names

- sole virtue of trade names – ease of recall and pronunciation – is far
outweighed by the
problems that stem from the existence of multiple trade
names for a single drug
- multiple trade names can impede name recognition and can
thereby promote medication
errors and miscommunication about drugs
- with generic names, facilitation of communication and promotion of
safe and effective drug is
completely opposite from trade names

IV. OVER THE COUNTER DRUGS (RTC)

- defined as drugs that can be purchased without a prescription
- whether a drug is available by prescription or over the counter is
ultimately determined by the FDA
- OTC drugs are an important part of health care
- provide relief from many ailments while saving consumers the expense
and inconvenience of visiting a
prescriber
- Americans spend about $20 billion annually on OTC drugs
- OTC drugs account for 60% of all doses administered
- 40% of Americans take at least one OTC drug every 2 days
- four times as many illnesses are treated by a consumer using an
OTC drug as by a consumer
visiting a physician
- the average home medicine cabinet contains 24 OTC preparations
- new labels titled Drug Facts will be written
- in plain language and will have a user-friendly format
- in large print that an be read
- active ingredients will be listed first, followed by uses, warnings,
directions, and inactive
 ingredients which all should help consumers select drugs that
can provide the most
benefit with the least risk

V. SOURCES OF DRUG INFORMATION

A. PEOPLE
1. Clinicians and Pharmacists
2. Poison Control Centers
3. Pharmaceutical Sales Representatives

B. PUBLISHED INFORMATION
1. Text-like Books 2. Newsletters
3. Reference Books 4. The Internet