Chapter 8- Political relatites of pharmacy Flashcards
“pocketbook” issue
experiencing RX cost indirectly through family members or paying higher premiums
What’s the avg. cost and time frame for bringing drugs to market?
10 years and over $1 billion dollars
How many drugs reach the market?
1 out of 250
What creates a prescription for political turmoil (2)?
- tremendous social value
- potentially unaffordable costs
What field is changing the basis of drug development and possibly all of health care?
genomics
What has our society began to grapple about as it pertains to genomics? (3)
- human cloning
- stem cell research
- genetic privacy
Who regulates the development, testing, marketing, and manufacture of drugs?
FDA
The Food and Drug Administration
Who issues patents that protect new drug products from competition for a period of time?
PTO
The Patent and Trademark Office
What is the “police”
force that stands between consumers and products that are unsafe, useless,
or improperly manufactured.
FDA
What directed the FDA to accelerate its review of new drug applications and
imposed fees on the companies requesting those approvals to finance the process?
Prescription Drug User Fee Act of 1992
T/F
The FDA limits financial ties between advisory committee members and companies whose products they review and DO NOT require disclosure of potential conflicts of interest.
- false
- DO
When are herbal supplements subject to much looser standards than that of the FDA?
when considered a food
Dietary Supplement Health and Education
Act (DSHEA)
classified herbal remedies as similar to foods and formally defined them as dietary supplements.
Under what act can herbal supplements be sold without pre-market approval?
DSHEA
When can the FDA prohibit the sale of herbal products?
if hazards are found, only AFTER they reached the market
