The law attempts simultaneously to be _ and also maintain a reasonable degree of
_. – correct answer -The law attempts simultaneously to be flexible and also maintain a
reasonable degree of certainty
Laws provide a framework within society. They are made prescriptively and proscriptively. What do
each of these terms mean? – correct answer –Prescriptively – command conduct which must be done
Proscriptively – command conduct which must NOT be done
What two things are considered public goods in the drug industry? – correct answer — Orphan drugs
- Vaccines
What is an example of an externality in the healthcare industry? – correct answer –Overuse of antibiotics
an externality occurs when the production/consumption of a good affects someone who does not
fully consent to the effect (ie indirect effects of the drug beyond the consumer/patient)
What is information asymmetry? – correct answer –Information Asymmetry is when the consumer is
uninformed about the true value of the good.
The US constitution is referred to as the “______________.” The constitution also creates
three branches of government – what is the name for this and what are the three branches? – correct
answer -The constitution is referred to as the “supreme law of the land“
The constitution creates three branches of government – Tripartite
Branches:
- Legislative – makes laws
- Executive – enforces laws
- Judicial – interprets laws
What is considered the “unofficial” fourth branch of the government? – correct answer –Administrative Agencies
these have the authority to “make” laws
What is the name of the clause that states that federal law is above state law? – correct answer –The Supremacy Clause
Define Statutory Law and give the hierarchal order of statutory law – correct answer –Statutory Law
is law made by legislatures (elected body of persons with primary responsibility to enact laws (statutes).
Federal Statutes
State Constitutions
State Legislation
Ordinances
What clause gives Congress the power to regulate interstate commerce? – correct answer -Commerce
Clause
this affects the movement of medicinal drugs and medical devices across state lines
What is a Federal Statute? What is the acronym used for these? – correct answer -A Federal Statute is
enacted by congress and execute by the executive branch
USC = United States Code
Law = Code = Statute
Ex: Pure Food and Drug Act, FDCA, Harrison Narcotic Act, etc…
Administrative Agencies:
- What branch of government are these a part of?
- Authority?
- Examples of these? – correct answer — Administrative Agencies are part of the Executive Branch.
However, they are also considered QUASI-LEGISLATIVE QUASI-JUDICIAL - Administrative Agencies have the authority to administer an area of substantive law.
- Examples: CMS, FDA, DEA, FBI, etc…
In Utah, DOPL and the Board of Pharmacy fall under which state branch? – correct answer -DOPL and
BOP fall under the Executive Branch.
DOPL is responsible for overseeing professional licensing and regulation
What are the steps of the Rule Making Process for Administrative Agencies? – correct answer -1. Notice –
placing proposed rules in Federal Register or State Bulletin
- Opportunity to be heard
- Public hearing
- Publication of final rule (Federal Register, Code of Federal Regulations (CFR), or Utah Bulletin)
What is common law? What is the latin term associated with referring to common law? – correct
answer -Common law is law made by the courts
From a case the judges record their decisions which then forms a body of law that can be used as a
precedent