FDA Law

3 hours. Food and drug law involves the statutory and regulatory framework governing the development and marketing of food, drugs, medical devices, biological products, and cosmetics. This introductory course serves as a starting point for understanding how the U.S. Food and Drug Administration attempts both to protect the public health and foster our national desire and need for innovation in science, medicine and the safety of our food supply. In particular, the course will study how FDA and the courts have enforced and interpreted the Federal Food, Drug and Cosmetic Act to implement a regulatory system for a wide range of products that affect our daily lives. Dialogue and questions on how food and drug law has confronted and adapted to scientific and technological progress, public health challenges, constitutional controversies, and policy-based perspectives will be encouraged. Additionally, the course covers such contemporary issues as food safety; balancing the benefits and risks of certain drugs, devices and biological products and how best to communicate that information to healthcare professionals and consumers; expediting approval of drugs designed for life-threatening diseases; clinical trials for experimental products; and regulation of biotechnology, such as tissue engineering and gene therapy. Other specific topics include: regulation of food labeling and sanitation; regulation of dietary supplements; administrative rulemaking; advertising and promotion controls; preemption of state laws; and strategies for handling government investigations and enforcement actions.