Food and Drug Law: Policy and Practice

The U.S. Food and Drug Administration regulates about a quarter of every dollar people spend in the United States, including $3 trillion worth of products. Its influence is both omnipresent and under continual scrutiny. From the regulation of grain in ancient times through modern-day approval of artificial hearts, COVID-19 countermeasures, and cutting-edge gene therapies, the laws and policies that protect and promote public health are the focus of this course, which examines them from a policy and practice perspective.

The seminar will employ both traditional lectures and experiential learning techniques such as role plays and simulations. Students will conduct discussions and debates from the perspectives of FDA regulators, members of Congress, Justice Department prosecutors, federal judges, doctors, and patients. We will analyze current and enduring issues in the regulation of foods, drugs, and medical devices; the breadth and limits of government enforcement powers; and the proper balance of promotional restrictions with the freedom of speech. Materials will include the Federal Food, Drug, and Cosmetic Act (an 85-year-old statute that has been amended dozens of times to meet changing public health needs), other federal laws and regulations, Supreme Court and lower-court case law, FDA industry guidance, Congressional hearings, and current media reports.