(a) Explain the essence of process by which a pharmaceutical company and Food and Drug Administration (FDA) function in development of a new medication, showing understanding of conflicts of interest which sometimes occur.

(b) Give evidence of personal insight into complexity of FDA's accelerated drug-approval decisions, sometimes driven by political and ideological also medical considerations, and also illustrate your understanding of profound ethical and moral questions posed when shortcuts are taken to permit quick and easy access to powerful drug for desperately ill patients.

(c) Explain major elements of recent federal approaches to enforcement of our drug laws, and point to some of the enormous difficulties and apparently positive consequences related with those approaches.