FDA Law and Policy

Catalog description

The Food and Drug Administration regulates roughly one quarter of the consumer economy in the United States. This course will introduce students to the basic principles of federal food and drug law, examining how significant doctrines of other bodies of law (such as constitutional law, administrative law, criminal law, tort law, antitrust law, and intellectual property law) have been elaborated and applied in this highly regulated setting. We will focus largely on medical products (pharmaceuticals, biotechnology, and medical devices) and nutritional supplements (a kind of "food") but from year to year there may also be units considering regulation of conventional food, cosmetics, tobacco products, and other categories of product regulated by FDA. We will explore the complex intersection of legal, ethical, policy, scientific, and political considerations that underlie FDA's regulatory authority, its policymaking, and its enforcement activity. Students will be assessed on the basis of class participation (which will weigh heavily) and a substantial writing project that involves research on a food and drug issue selected by the student (and approved by the professor). The course will be helpful preparation for students on a variety of career paths whose work may at some point involve clients, or opposing parties, regulated by FDA. Credit Hour : 1-3 Recommended: (LAW 5220) Constitutional Law, ( LAW 5310 ) Administrative Law, and ( LAW 5640 ) Intellectual Property would be helpful