The Food and Drug Administration (FDA) regulates 25% of the U.S. economy and exerts decisive authority over the commercial availability of new therapeutic drugs and medical devices by controlling pharmaceutical patents, drug and device manufacturing and clinical research. The Agency plays a leading role in assuring the safety of food grown, imported and distributed in the U.S. and controls food labeling, including use of the terms "organic" and "natural." Through lecture, reading assignments and discussion, this course will provide background on the legislative authority which underlies FDA activities, the processes and procedures by which the Agency carries out its mandate and the public policy debates which deal with the tension between accelerating approval of new treatments for incurable diseases such as AIDS, cancer and Alzheimer's disease and the demand to improve the safety of marketed drugs and foods. Enrollment is limited.
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