(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) Provide evidence of personal insight into the complexity of the FDA's accelerated drug-approval decisions, sometimes driven by political and ideological as well as medical considerations, and also show your understanding of the profound ethical and moral questions posed when shortcuts are taken to allow quick and easy access to a powerful drug for desperately ill patients.
(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 approaches.
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