Food and Drug Law, Policy, and Practice

The FDA regulates products accounting for 20 cents of every dollar consumers spend in the United States, making food and drug law a major driver of litigation, corporate practice, intellectual property, administrative law, and regulatory counseling.

Drawing on doctrinal, policy, and practice perspectives, the course examines the law's role in protecting and promoting public health. We will analyze the laws governing FDA jurisdiction, product classification, enforcement, and regulatory authority over food, drugs, and medical devices. We will examine high-stakes controversies including the regulation of artificial intelligence in medical devices, the marketing of cell-cultured meat, the multi-front legal battle over mifepristone, and the market disruption caused by cutting-edge gene therapies and blockbuster GLP-1 weight-loss drugs.

Moving beyond traditional lectures, the course connects legal doctrine with real-world practice through policy debates, simulated Supreme Court arguments, and mock FDA negotiations with regulated companies. In these exercises, students will step into the roles of FDA regulators, Justice Department prosecutors, members of Congress, federal judges, public-interest advocates, and corporate counsel.

We will examine the scope and limits of government enforcement, the First Amendment implications of commercial speech restrictions, the role of recent shifts in presidential assertions of authority and judicial review, and the inherent tension between consumer autonomy and federal oversight.

Materials include the Federal Food, Drug, and Cosmetic Act, Supreme Court and appellate case law, FDA industry guidance, and breaking media reports.