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FDA Business Ethics

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

. . .

It is not known if thalidomide is present in male ejaculate (semen). ä: System for

Thalidomide Education and Prescribing Safety. This elevated level may contribute to the detriment of a patient's condition. The deontological theory bases morality on specific, foundational principles of obligation. You must continue these methods until one month after the last dose of thalidomide. The FDA can approve or disapprove the use of thalidomide. All of the foreseeable benefits and harms that would result from each course of action for everyone affected by the action must be acknowledged. Neither Chemie

Grunenthal, the drug company, nor Richardson-Merrell, the American

licensee, could or would answer her questions, and so the drug went

unapproved in the United States. Physicians must register

and receive education and requirements before dispensing prescriptions for

thalidomide. These theories are called deontological theories, from the Greek word deon, or duty, given the foundational nature of our duty or obligation. The use of thalidomide would aid many people by allowing their quality of life to improve.

. Results of this test must show that you are not pregnant.

Approximate Word count = 1956
Approximate Pages = 8 (250 words per page double spaced)

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