The mission of the Food & Drug Administration is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world. The law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive. The job of the FDA could be considered an ethical dilemma in itself. The ethical dilemma of the FDA is found in the fact that one organization is given the supremacy and task of deciding what drugs are used in life saving and life improvement, but by narrowing the assignment of the FDA down to one instance will demonstrate the ethical perplexity faced by the Food & Drug Administration. That one illustration is the approval of the drug thalidomide.
In the early 1960s the very mention of the word "thalidomide" was
enough to conjure up the vision of a parent's worst nightmare: the birth of a
deformed child. During that period, approximately 8,000 babies were born in
Europe with severe defects after their mothers had taken thalidomide. The
drug, a sedative, had been virtually untested for its effects on pregnancy.
Thalidomide first appeared in Germany on the 1st of October 1957. It was
marketed as a sedative with apparently remarkably few side effects. The
drug company who developed it believed it was so safe it was suitable for
prescribing to pregnant women to help combat morning sickness. But
towards the end of the fifties, children began to be born with shocking
disabilities. It was not immediately obvious wh...