Question

pharmaceutical industry is regulated by both the federal and state governments. The FDA is the primary federal agency that regulates the approval and sale of drugs. State licensing boards generally have responsibility for the distribution and sale of prescription drugs within a state’s boundaries. The FDA regulations are intentionally written to make it difficult to get new drugs approved to market to the public. Tell me at least three reasons why the federal government would want to make the approval process difficult and tell me three problems the difficult approval process causes for those in need of new drug treatment. State licensing boards have general regulatory oversight of FDA approved drugs sold in a particular state. We talked about a partular class of specially made drugs that had fallen ‘between the cracks’ of both federal and state regulation/oversight until recently. What are these specially made drugs called and what are at least two problems these type drugs have caused?

Answer 1

Three problems the process cause for those in need of new drug treatment

Why Federal Government wants such a process- 1. To promote public safety and ecourage the development of safe and effective drugs, 2. New drugs are rigorously tested for safety, efficacy and minimal side effects. 3. This regulation of the drug sector has resulted in a longer, more-expensive product development process that favors treatments for rare illnesses.

Three problems that the approval process can create:

1. The difficult approval process limits the researchers' ability to study new drugs for its medical value and hence lesser new drugs enter the market. 2. Exploring new drugs require a large amount of fixed investment which requires incentives and returns but in a stringent system like this, it is difficult as the process of introducing new drug lengthens and is tighter. 3. The process creates significant entry barriers in the market and hence lesser competition