Pharmaceutical Regulation and Enforcement (Davar)
R 6:30PM - 8:30PM
Tanenbaum Hall 112
The course will introduce students to the complex legal and regulatory framework governing the pharmaceutical industry, as well as current theories of government enforcement against drug companies and individuals as they relate to the federal Food Drug & Cosmetic Act, Anti-Kickback Statute, False Claims Act, and related laws. Sessions will be discussion-based and broken into modules surveying topics such as clinical research regulation, industry relationships with healthcare professionals, drug manufacturing, and other topics. Readings will focus on real-world case studies and regulatory/legal background materials used by private practitioners, regulators, and enforcement officials, such as regulatory policy manuals, agency guidance, and court filings. Some sessions may also include informal presentations by guest speakers who are experts in their field. Students will be evaluated both on their preparation for group discussions, as well as a research paper. No background in healthcare science or administrative law is required, however an interest in the material and participation in discussions is mandatory. This course may be of particular interest to students interested in building upon other coursework in legislation, healthcare law, or cross-divisional coursework in medical ethics.