Questions 6

Topics: Clinical trial, Pharmacology, Medicine Pages: 3 (535 words) Published: May 12, 2015
Study Questions 6

1. What is the role of the pharmaceutical industry in the health care system?

The pharmaceutical industry plays a pivotal role in the health care system. Without the pharmaceutical industry, health care would not evolve into what it is today. The reason why it plays such an important role in health care is because it helps address challenges associated with modern day diseases and illnesses. It controls prevent, treat, and cure many types of diseases. In support, according to Williams and Torren, “ Biotechnology offers new approaches to discovery, design, and production of drugs and vaccines, and diagnostics.” 2. What are the regulatory and legal issues related to drug and pharmaceutical development and sale?

The regulatory and legal issues related to drug and pharmaceutical development and sale is very complex. In order for the FDA to approve this drug for sale it must go through a very long lengthy process of it being approved. This long process can be costly and is considered highly risky. To achieve the point where you can sell your drug, the drug company must go through drug discover and testing. This is when thousands of scientists are employed to test the drug and do clinical testing. Once you pass the rigorous process of the FDA guidelines, your drug will then go through post approval safety and marketing. During this process, safety monitoring becomes a big issue. Next is labeling, advertising and promotional claims. Legal issues can occur during clinical testing to when the drug is out for the public to use.

3. What is the role of the pharmaceutical and biotechnology industry in making products available to the poor in the United States?

Underutilization of new effective drugs is a serious concern for pharmaceutical companies. There are many restrictions on pharmaceuticals companies to make their drug available for everyone. Certain restrictions like Medicaid will only allow specific medicine to be...

References: Williams, S.J, Torrens, P.R., (2008). Chapter 11: The Pharmaceutical Industry. Introduction to Health Services (7th ed).
Williams, S.J, Torrens, P.R., (2008). Chapter 11 PowerPoint Slides: The Pharmaceutical Industry. Introduction to Health Services (7th ed).
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