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Pharmaceutical Regulation and Enforcement (Davar)
Spring 2014   LAW 920-001  

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Meeting Times/Location
R 6:30PM - 8:30PM
Tanenbaum Hall 112

Mahnu Davar

Lecturer in Law
Additional Information

Course Concentrations
Health Law
Administrative and Regulatory Law

Skills Training
Expository Writing

40% Participation,
60% Paper

Satisfies Senior Writing Requirement

With Permission of Instructor
The paper review process will have a thesis/idea review component as well as a final paper submission. Students' grades will factor in the extent to which professor' comments/considerations in the thesis/idea stage were considered in the final draft.



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.