1. (a) Describe the essence of the process by which a pharmaceutical company and the Food and Drug Administration (FDA) function in the development of a new medication, showing understanding of conflicts of interest that sometimes occur.
(b) Describe the Comprehensive Drug Abuse Prevention and Control Act of 1970. Include the criteria for listing a drug as a Schedule 1 – Schedule V controlled substance and give some examples of drugs that are in the Schedule 1 – Schedule V.
(c) Describe the major elements of recent federal approaches to the enforcement of our drug laws, and indicate some of the enormous difficulties and apparently positive consequences associated with those
1A. The Food and Drug Administration (FDA) monitor drugs that have been altered and ones that did not correctly list certain ingredients. The FDA also looks into drugs that are considered to be therapeutic. When the FDA first came about many companies found loop holes that the FDA did not approve of. For example in 1922 the FDA went after the B&M External Remedy. Its manufacturers truly believed it was a cure for tuberculosis. This made a loop hole that made it seem like anyone who was unaware but assumed what the medication did could market it. Another issue the FDA had was the regulation that a drug had to be safe to the people that were taking it. In 1938 the FDA made drug companies turn in a “new drug application” (NDA).
A NDA was a report of a drug being safe for use. Since the FDA enforced companies submitting a NDA before a drug hit the market it made it safer for everyone. The NDA not only allowed the FDA to do testing on drugs that were already on the market it also made companies hire scientists and not be run by just anyone. Also with a NDA being submitted drugs had to be labeled with directions on how to properly use the drug or that the drug could only be used with a prescription. This was a...