Testing and Approval of Drugs

1. Patents protect inventors for 20 years after discovery and give the inventor exclusive rights to market their invention during that time. Drug companies argue that the long time between discovery of a new drug and the time patents are awarded makes it difficult for them to recover the cost of discovering/testing new drugs. Should the patent system be overhauled for drugs?

2. Only a tiny percentage of drugs that enter testing ever are released to the public due to safety/effectiveness concerns. This causes drug companies to focus attention development of drugs for which there is a very big audience. Consequently, diseases for which there is a small set of clients or which strike mainly poor countries are not actively researched. What, if anything, should be done to fix this?

3. If you had a condition that had a success rate of treatment with an existing drug of 75%, would you be willing to participate in a drug safety test for a new drug of an unknown success rate? Why or why not? Remember that in order for a drug to be approved by the FDA, it must be demonstrated as safe and effective in human subjects.