Analytical Paper Optional: All enrolled students have the option of completing a research paper of at least 20-25 pages, with faculty and peer review of a substantially complete draft. This paper can be used to satisfy the analytical paper requirement for J.D. students.

Prerequisite: None

Exam Type: No Exam
A paper is required.

This course explores the full range of federal regulation of products subject to the jurisdiction of the Food and Drug Administration (FDA). These products include food, prescription and nonprescription drugs, animal food and drugs, biological products, medical devices, cosmetics, and tobacco products, which together account for more than 20 cents of every dollar spent by U.S. consumers. The course examines the public policy choices underlying the substantive law, FDA enforcement power, and agency practice and procedure. The course covers contemporary issues such as health-related claims for food and dietary supplements, protection against unsafe food ingredients and food-borne pathogens, evolving standards for demonstrating drug effectiveness, expedited approval of drugs for serious illnesses, compassionate use of experimental medical products, FDA intervention in the practice of medicine, prescription drug advertising, switches from prescription to nonprescription status, the use of antibiotics in farm animals, regulation of AI and other new medical device technologies, vaccine approval, FDA oversight of cutting-edge biotechnology, and regulation of e-cigarettes.

Note: This course will meet for twelve class sessions through Thursday, January 21st, with no class meetings on Wednesday, January 13th and Wednesday, January 20th. There will be a full day simulation (morning and afternoon) one day during the winter term, date TBD. Further scheduling details will be provided on the course Canvas page closer to the start of the term.