LAW7594 - Food and Drug Law

LAW7594 - Food and Drug Law

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The Food and Drug Administration is the oldest federal regulatory agency. Its lineage can be traced back to 1848 when it was established as the Agricultural Division of the Patent Office. It has grown into one of the most important agencies of the federal government; products regulated by FDA account for approximately 25 cents of every dollar spent by US consumers. Its influence is pervasive, extending to standards for foods, drugs, cosmetics, medical devices, and even aspects of consumer products such as microwave ovens and color television sets. This seminar is intended to provide students with a grounding in the basic statutory and regulatory authorities under which FDA operates. Many of the issues to be discussed represent major current policy issues: drug approval standards, food safety regulation, regulation of biotechnology, advertising and promotion (including the tension between the First Amendment and constraints on manufacturer speech), dietary supplements, availability of AIDS and other drugs prior to approval, and FDA's involvement in both the intellectual property and scientific issues surrounding approval of generic drugs and biotech products. The course will require a written paper.