Prerequisite: None

Exam Type: No Exam

This seminar examines innovation law and policy in the context of drugs and devices regulated by the Food & Drug Administration. It explores problems relating to data generation, patents, market exclusivities, tax credits, funding models, innovation design, public governance, and private ordering. Among the questions we will address are the following:

1. What are the stated and actual effects of laws that regulate drugs and devices?
2. How and why do laws directed at devices and drugs differ in scope and substance?
3. What laws other than the Food, Drug, & Cosmetic Act influence drug and device development?
4. What kind of innovation issues demand new legal regimes rather than a reliance on old ones?
5. How do issues of federalism and interagency cooperation affect innovation of drugs and devices?
6. Which actors are best positioned to competently assess innovation challenges for drugs and devices and to implement appropriate changes?

To examine these questions, students will read cases, legislation, administrative regulations, government documents, and academic works. Student performance will be evaluated based on a final paper (80%) and participation (20%).