COURSE DESCRIPTION 2012 2013

Prof. Marc A. Rodwin,

3 credits day; 3 credits evening. Grading based on a mid-term and end of semester exam and on class participation.

This course focuses on pharmaceutical industry regulation and policy in the United States. It examines: the Food and Drug Administration process used to approve the sale of drugs; exclusive marketing arrangements; regulation of clinical trials to evaluate drug safety and effectiveness; regulation of drug marketing; prescribing drugs for off-label uses; financial and legal responsibility for drug induced injuries; post-marketing drug safety; drug firm financial relations with physicians and medical institutions; funding of research and development; pricing and access to drugs; the relation between U.S. and international drug markets and regulation.

Elective Course

Final Exam Required

E-Commerce and the Law