Exam 1 (Overview) Flashcards
Public Goods
Necessary and beneificial commodities that private entities will not supply because no incentives (ORPHAN DRUGS)
Externalities
When production or consumption of a good affects someone who does not fully consent to effect. When cost of goods are not fully incorporated into price (OVERUSE OF AB)
Natural Monopolies
When fixed cost of providing a good are high relative to the variable cost of production. Avg cost declines over time. (Gives patent holder ability yo exclude others from making products that would compete)
Information asymmetry
When consumer is uninformed about the true value of a good (More or less information from one party)
Minor Violations
Excused as long as it does not affect patient safety (ADULTERATION and MISBRANDING are unexcused)
Executive branch (FED)
Enforce laws, promote regulations, must be within agencies authority
FDA, DEA, CMS, FTC
Legislative branch (fed)
Make laws
Powers are vested in constituion (A.1 s.1)
Judicial (fed)
Interpret laws
Established by article 3 of constitution
State Law
- (3) Branches (like fed)
- Have power to legislate
- BOPh (Admin branch under executive)
- Highest is Supreme Judicial Court
- Key agencies (Dep of Med. Assistance) (Dept of Public Health)
- State license to practice, not federal
De Novo
Court demands new trial due to insufficient evidence in admin agency judicial trial
Code of Fed. Regulations
Compilation of final regulations divided and indexed by subject matter
- 50 titles.
Title 21
Title contains all of the FDA Regs in the CFG
Federal Register
Daily pub.
- Federal Actions
- Proposed Regulations
- Final regulations
- Govn notices
535, 100, 435
Congress = 535
- 100 Senate
- 435 Reps.
President Veto?
2/3 vote
