HLTH 385 Lecture 19: Lecture 19
• Role of FDA: insure that new drugs are safe and effective
• Phase 3 trial: trail where the drug is compared to a placebo or another drug on the
market already
• Approval threshold: intermediate endpoint?**
o "Patient-centered endpoint"- this is hard to define
• When a drug is approved, it gets a product label
• Approval significance
o Impacts how the drug company can market the drug
o Coverage (impact the drug will have, whether or not its useful)
• Drug costs
o A few cases of talk about companies raising their drug costs very rapidly
o Patients out of pocket costs are high
o New drugs- more costly
o Corporate in nature- easy for politicians to single out a company that has a
high cost drug vs. hospital that has high cost surgery
• Hospitals have more favor in eyes of politicians and thus the eyes of
voters
• No drug company in your district- easy target for politicians
• 10% of all healthcare spending go towards prescription drugs
• Price setting
o On patent vs off patent drugs
• Each drug is usually covered by multiple patents
• Effective patent length
• The system encourages innovation
o Some mandates that require drug companies to give discounts to certain
groups of people
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