Midterm Laws Flashcards
(31 cards)
1890 Sherman Antitrust
applies to all competitive markets and prohibits competitors from price fixing, boycotting. Complex law but maintains competition and low prices.
1936 Robinson Antitrust
allows volume med discounts: large purchasers get lower prices (hospitals, HMOs). These institutions cannot compete with retail pharmacys using discounted drug prices
4 elements of negligence
- Duty owed
- Breach of Cuty
- Causation
- Damages
Tort
A civil wrong that unfairly causes someone to suffer loss/harm resulting in legal liability
Laws of contract
- mutual agreement between more than 2 people
- legally competent parties
- consideration of anything valuable promised in another contract
- lawful purpose or object
express warranty
written and available to buyer
implied of merchantibilty
not written
exclusion of implied warranties
sold as is
1906 Pure Food and Drug Act
address the ineffective and unsafe remedies
protection from adulterated/misbranded food/drugs
1938 Food Drug and Cosmetic Act
FDA regulates drug safety, quality regulations
no drug is marketed until proved safe
need adequate directions for use
1951 Durham-Humphrey Administration
RX only/established OTC drugs
based on public use safely with adequate directions for use
1962 Kefauver-Harris Administration
Proof of safety and efficacy
established good manufacturing practices=GMP
clinical trial safeguards and adverse reaction reporting
1983 Orphan Drug Act
tax/licensing incentives for drugs that have little/no commercial values for rare diseases
applies when drug development costs much more than returns
1984 Drug Price Competition
aka Waxman Hatch Administration
generic drug approval to make more readily available
the FDA determines the bio-equivalence, lists in Orange Book
1992 Prescription Drug User Fee Act
drug/biologic manufacturers pay a fee for product applications and those funds are used to hire more reviewers to speed up the review and approval process
1994 Dietary Supp Health and Education Act
specific labeling requirements and GMP for dietary supplements. The manufacturer is responsible for ensuring dietary supplements is safe. No disease prevention claims allowed
1997 Food and Drug Modernization Act
reauthorizes prescription drug use act to accelerate review of devices, regulate the unapproved uses of drugs and devices and deals with health claims for foods.
2007 FDA Administration Act
$1.2 M for New Drug Application. Encourages research on children and pediatric medicines.
Pediatric Research Equity Act
medication guide/pkg inserts
2013 Drug Quality and Security Act
large compounding pharmacies must register as outsourcing facilities
Drug supply chain security act-track and trace all Rx drug sales
product claims ad
drug, indication, claims of safety and efficacy
reminder ad
drug, dosage form, and cost
help-seeking ad
describes disease
NDC number
first 4-labeler
middle 4-product code
last 3-pkg code
1970 Poison Prevention Act
child resistant pkging for OTC and RX meds
pt can opt out in writing
exceptions: nitroglycerin and some medications for the elders
