Course Description

601:505. FOOD AND DRUG LAW (3)


Events have refocused public attention on the role of the FDA in protecting public health. Given that more than a quarter of the national economy is directly affected by FDA regulation, the attention is long overdue.

We will approach our study in a couple ways. On one level, the course is a resume of legal efforts stretching back more than a century to assure the quality of foods and medicines Americans consume. That task has often fallen to the FDA, which is obviously a federal agency. In large part, then, this is an illustrative course on Administrative Law. No previous experience needed, although those students who have taken Administrative Law will benefit from seeing its generalized doctrines at play across the workings of a single agency.

A final issue will be the intersection of the FDA regulation with our common law system of litigation.

Grading will be done via take-home exam/paper, which will require substantial outside research.