The Law and the Legal
System
Pages 1-24
1
Treaties
Legislative Branch
Acts of Congress
(U.S. Code)
Federal
Government
Statutes Create
Agencies and
Authorize
Agencies to Pass
Regs
Executive Branch
Federal Agencies
(FDA; DEA, etc.)
Federal Regulations
(CFR)
Judicial Branch
Supreme Court
Court of Appeals
District Courts
U.S Constitution
State Government
Legislature
Statutes
Governor
State Agencies (i.e.,
Board of Pharmacy)
State Regulations
(Board of Pharmacy
Regs)
State Supreme
Court
State Appellate
Court
State Trial Courts
2

FEDERAL

U.S. Constitution
 No federal or state law may conflict

Legislature (Congress)
 House
 Senate


Administrative Agencies
Courts
 Supreme Court of United States
 Appellate Courts (11 + D.C. Circuit + Federal Circuit = 13)
 District Courts (Trial Courts)
3

STATE
State Constitution
 State Legislature
 State Administrative Agencies
 State Courts

 Supreme Court
 Appellate Court
 Trial Courts
4
Administrative agencies are created by
legislatures to administer a body of substantive
law
5


Render decisions pursuant to “hearings”
resembling court proceedings
Decisions subject to judicial review


Court will review record to determine if decision
was based upon substantial evidence
De novo: If substantial evidence lacking, court
will conduct an entirely new trial
6



Regulations published in Federal Register (Fed.
Reg.) and Code of Federal Regulations (CFR)
Federal Register: Daily publication of proposed
and final regulations and notices
CFR: Compilation of final regulations divided
and indexed by subject matter
7


Common law refers to judicial opinions and was
adopted from the English judicial system
Judicial opinions: Decisions of the court
Enforceable as law
 Binding on lower courts in the same jurisdiction


Stare decisis
Opinions are binding on lower courts in the same
jurisdiction and serve as precedent
 Reasons for deviating from precedent include factual
distinctions and changing times or circumstances.

8


Courts often must interpret the meaning and
application of statutes
Principles of interpretation include:
Determining legislative intent if possible.
 Ordinary meaning of words
 Due process rights of the individual

9

Criminal: Government v. private party



Civil: Private party v. private party



Charged with a crime as prohibited by a statute and
subject to penalties specified by statute
Objectives: Deter, punish, rehabilitate
May be based upon statute or common law legal rights
Objective: compensation to injured party
Administrative: Agency v. private party

Disciplinary determination which may include warning,
fines, licensure revocation or suspension, probation
10





When federal and state law conflict, federal law will
preempt state law under the Supremacy Clause of the U.S.
Constitution (preemption; dominating the field of law)
Conflicts generally exist when state law is less strict than
federal law.
Federal authority to regulate drugs general arises from the
Interstate Commerce Clause of the U.S. Constitution
State authority to regulate generally derives from the Tenth
Amendment to the U.S. Constitution and under its
inherent police powers.
State laws must bear a reasonable relationship to the public
health safety and welfare (pharmacy laws).
11
There is NO preemption unless contradictory
(i.e., fed law does not “occupy” the topic)
EXAMPLE
21 USC Sec. 801-970
(Drug Abuse Prevention and Control Act of 1970) also known as
(Controlled Substance Act (CSA))



21 USC Sec. 903. Application of State law
No provision of this subchapter shall be construed as indicating an intent
on the part of the Congress to occupy the field in which that provision
operates, including criminal penalties, to the exclusion of any State law
on the same subject matter which would otherwise be within the
authority of the State, unless there is a positive conflict between that
provision of this subchapter and that State law so that the two cannot
consistently stand together.
(cf., E-Sign law, discussed later)
12
•
Health and Safety
•
1850’s – Study showed decrease in life expectancy
from adulterated food and drugs
•
1937 - Elixir Sulfanilamide Tragedy
13
•
Health and Safety (cont’d)
•
Elixir Sulfanilamide – S.E. Massengill Company
• 1937, Sulfanilamide – sulfa anti-infective. S.E. Massengill
company chemist made “elixir” form of medicine (was in
tablet form only prior to this). Chemist used diethylene
glycol (DEG) and a flavoring agent for liquid formulation.
DEG is a solvent used in anti-freeze - it is a poison. 107
Deaths. Only liability was “misbranding” for calling it
“elixir” but it had no alcohol. Led to passage of Food, Drug
and Cosmetic Act of 1938.
• DEG Also used recently (2007) in tooth paste from China
found in U.S., and cough syrup from China resulting in at
least 40 deaths, mostly children, in Panama.
14
•
Health and Safety (cont’d)
•
1950’s Thalidomide
• Sedative primarily for morning sickness
• Trials in U.S. but never received FDA approval after reports
world-wide of birth defects (primarily limb deformities, but also
ear and various organ deformities)
•
Deformity from Thalidomide >>>>>
• Taken off market in 1961
• FDA approval in 1998 for multiple myeloma
• Led to Kefauver-Harris Amendment of 1962 , requiring new
drugs be not only safe but also EFFECTIVE.
15

In the late 1800s cocaine products started flooding the
market: there were lozenges and pastilles, elixirs and pills.
The most notable, however was cocaine wine, which was
first sold in Europe under the name of Vin Mariani, named
after its creator Angelo Mariani in 1860. It was a roaring
success, and spawned an army of impostors. In the US, an
enterprising chap by the name of John Styth Pemberton
brought out his own version of the drink in 1881. He was
moderately successful, but in 1885, Atlanta banned the sale
of alcohol. Clearly, something had to be done. So Pemberton
changed the recipe, took out the alcohol, and sold his new
drink under the name Coca-Cola. It was good, but not great.
Disillusioned that his fortune hadn't been made overnight,
he sold the entire operation to Asa Griggs Candler for a
paltry $2,300.
16


In the 1890s the Sears & Roebuck catalogue, which was
distributed to millions of Americans homes, offered a syringe
and a small amount of cocaine for $1.50.
Below is their ad for a cocaine drink.
17