Discussion
There is an overlap on the jurisdiction of the centers given that various centers exercise the authority already assigned to other centers. This overlap causes confusion over which center’s authority should be adhered to. While the authority of FDA overshadows that of center for Toxicology Research, the center for Toxicology Research reserves certain amount of authority and jurisdiction in the researching toxicology. The overlap in jurisdiction is demonstrated by the fact that FDA holds the overall authority while center for Toxicology Research practices its authority within the center (Mossinghoff, 1999).
Given that the center for Toxicology Research is not concerned with the production of a particular product, it should be allowed to stand alone. It should be noted that the centre for Toxicology Research is a branch of FDA concerned and focused research pertinent to toxicology. Also, it is significant to note that the center for Toxicology Research reports all it’s finding to FDA. As a consequence, FDA overlaps its jurisdiction past the authority exercised by center for Toxicology research. FDA exercises its authority through the center for Toxicology Research. This indicates an overlap in jurisdiction given that the center for Toxicology Research achieves FDA’s goals of protecting and promoting public health through these researches on toxicology.
There are numerous consequences associated with failure to adhere to FD&C Act: the application of a civil penalty not exceeding the amount of one million US dollar is applicable to persons who fail to adhere to FD&C Act. Also, distributers or manufacturers who distribute sample drugs with a total disregard to FD&C Act shall be fined with a civil penalty not exceed fifty thousand dollars for each of the first two violations (Mossinghoff, 1999).
Part 2
The use of animal for preclinical testing has been under debate by some of the organizations supporting animal rights. Animals, specifically lab rats, are used for testing medical research products before they can be tested in human beings. These animals play a significant role in the research and development of drugs. Additionally, they help in testing possible side effects of new drugs and treatments before they are applied in human trials. Research and development of new medicine and therapies would suffer a great deal in case the use of animals in preclinical testing is abolished. It will force medical researchers to roll out new drugs and therapies without any idea on possible effects they may have on human beings.
References
Mossinghoff, G. J. (1999). Overview of the Hatch-Waxman Act and its impact on the drug development process. Food & Drug LJ, 54, 187.
