Drugs Flashcards
Trends: Drug spending has been _
Large increases in 90s:
Spike in 2006:
Decrease in 2010:
Trends: Drug spending has been increasing
Large increases in 90s:
- blockbuster drugs introduced have
- their patents have expired, leading to lower prices from generic manufacturers
Spike in 2006:
- Medicare Part D
Decrease in 2010:
- ACA - Medicaid’s provision that reduced prices paid for prescription drugs
Main drivers of prescription drug spending growth (3)
Main drivers of prescription drug spending growth (3)
Increasing prices of existing drugs
Increasing use of existing drugs
Increasing use of new (expensive) drugs: shift away from older to newer drugs
The Life Cycle of a New Drug From its Initial R&D Through its Sales Revenue
When are cost incurred?
When do they make money?
4 milestones?
The Life Cycle of a New Drug From its Initial R&D Through its Sales Revenue
When are the cost incurred?
- R&D and clinical trials
When do they make money?
- market exclusivity (Patent)
4 milestones?
- Patent before R&D
- FDA evaluation
- Market exclusivity
- Patent expires
Steps in FDA approval process (5)
Steps in FDA approval process (5)
- Discovery stage
- apply for a patent
- Pre clinical
- File IND (investigational new drug)
- Phase 1 CT
- Phase 2 CT
- Phase 3
- file NDA (new drug app)
FDA Approval’s Tradeoffs
Stringency of FDA decision to approve NDA weighs _ to patients against _ to them
Raising the bar?
Lowering the bar?
FDA Approval’s Tradeoffs
Stringency of FDA decision to approve NDA weighs benefits to patients against risks to them
Raising the bar?
- limit access to drugs
Lowering the bar?
- increase risk to patients
Prescription Drug User Fee Act (PDUFA)
What was it?
What did it do? (2)
Prescription Drug User Fee Act (PDUFA)
What was it?
- Aimed at cutting down new drug application NDA evaluation time
What did it do? (2)
- Established user fees paid by the drug companies in order to increase the amount of FDA staff
- Established standard vs priority tiers
Describe FDA Modernization Act of 1997
FDA Modernization Act of 1997
Added fast track for drugs treating serious conditions with no therapy
FDA approval in the US compared to other countries
FDA approval in the US compared to other countries
- FDA approval in the US does not incorporate the price of a drug
off-label uses for approved drugs?
Marketing?
Off-label uses for approved drugs?
- once drug approved, can be prescribed for off-label uses for conditions other than the intended use.
Marketing?
- drugs can only be marketed for their intended use (on-label)
FDA approval of new drugs has been _ over time
FDA approval of new drugs has been decreasing over time
FDA approval process is _ pharmaceutical generics and brand name drugs
1984 Hatch-Waxman?
FDA approval process is similar pharmaceutical generics and brand name drugs
1984 Hatch-Waxman?
- Made a straightforward pathway to establish equivalence (generics)
FDA approval process for “Follow-On Biologics” a.k.a. “Biosimilars”
What created the pathway?
Difficulty?
FDA approval process for “Follow-On Biologics” a.k.a. “Biosimilars”
What created the pathway?
- ACA (equivalence, patents)
Difficulty?
- difficult to establish the year when patent exclusivity ends because there can be so many patents in effect for biologics
Fraction of Costs Devoted to R&D is _ for Pharmaceuticals Relative to Most Other Industries
Fraction of Costs Devoted to R&D is high for Pharmaceuticals Relative to Most Other Industries
Controversy about Whether Federal R&D Spending Is a Substitute or Stimulant for Private R&D?
3 takeaways
Private R&D _ NIH R&D(feds)
Substitution:
Complement:
Controversy about Whether Federal R&D Spending Is a Substitute or Stimulant for Private R&D?
3 takeaways
Private R&D > NIH R&D(feds)
Substitution:
- opponents, industry unfairly benefits from all of this federal funding on research
Complement:
- proponents, encourage private spending that might not happen
- Providing some of that initial basic science to in turn encourage private spending that might not otherwise happen
Advantages and disadvantages to public from longer patent protection:
Advantages (2)
disadvantages (2)
Advantages and disadvantages to public from longer patent protection:
Advantages (2)
- Primary advantage
- innovation encouraged by potential monopoly profits,
- Secondary advantage
- public disclosure of information (research “spillovers” to other companies to examine and work)
disadvantages (2)
- Primary disadvantage
- “unfairly” high prices during longer market exclusivity
- Secondary disadvantage
- high prices = fewer people obtaining drugs
