Author Question: The Orphan Drug Act was passed in 1983. Which statement describes the purpose of the Orphan Drug ... (Read 163 times)

123654777 · **on:** Jul 23, 2018

The Orphan Drug Act was passed in 1983. Which statement describes the purpose of the Orphan Drug Act?

a. To limit the development of single-purpose drugs for common illnesses
b. To provide a means for rewarding cost-effective behavior by pharmaceutical companies
c. To encourage pharmaceutical companies to produce a greater number of novel, or one-of-a-kind, drugs
d. To provide tax incentives to pharmaceutical companies who develop drugs to treat rare diseases

Question 2

A clinical drug trial is being conducted on 3000 people using a double-blind research design. Which clinical trial phase does this study represent?

a. Phase 1
b. Phase 2
c. Phase 3
d. None of the phases are applicable

blakeserpa · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

ANS: D
The Orphan Drug Act of 1983 was passed to motivate companies to develop orphan drugs, which are defined as those used for the diagnosis, prevention, or treatment of diseases that affect less than 200,000 people in the United States. The law offers substantial tax incentives and long-er patent protection to companies that develop drugs that would not otherwise be good financial investments.

Answer to Question 2

ANS: C
A phase 1 clinical drug trial involves healthy people. Phase 2 uses diseased or ill volunteers. Phase 3 uses a sample of people using a double-blind research design to eliminate research bias.