Pharmaceutical Regulation and Enforcement (Davar)
R 6:30PM - 8:30PM
Silverman Hall M28
Description: 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 will 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 structured research paper. No background in healthcare science or administrative law is required, however an interest in the material and participation in discussions is mandatory. Students may only take planned absences (including leaving early or joining late for journal meetings or job interviews) with prior approval of the professor. 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. Because this course focuses on "late breaking" developments in this area of law, the syllabus is likely to evolve as the semester progresses.
Excused Absence Policy: Unless truly unforeseen (sickness, family issue), you must get approval in advance of missing a class. In order to get participation credit for a missed class, you will be asked to provide a brief response paper covering the subject matter presented in the readings that you missed and due by the Tuesday following the missed session. Absent extenuating circumstances, you will lose credit for unexcused absences, particularly if the reasons are reasonably foreseeable.
Law School Comment Policy: If you are interested in using this course for your law school comment (i.e., using your final exam paper to satisfy your comment requirement, you must provide me a signed Registrar form at the start of the 5th session). Due to time constraints, I am afraid I will not be able to serve as a Law Review comment supervisor for this coming year.
Skills Learning outcomes: Demonstrate an understanding of the individual course skill; Demonstrate the ability to receive and implement feedback; Demonstrate an understanding of how and when the individual course skill is employed in practice.
Health Law Learning outcomes: Demonstrate a core understanding of health law and policy; Perform legal analysis in the context of health law and policy; Communicate effectively on topics related to health law and policy; Demonstrate an understanding of the interconnection among health law and policy and issues of access to services, public and private financing of health industries, and the political and economic issues surrounding issues of health law and health services.
Perspectives on the Law Learning outcomes: Demonstrate an understanding of how the law affects, and is affected by, the individual course topic; Perform legal analysis in the context of the individual course topic; Communicate effectively on the legal and other aspects of the individual course topic; Demonstrate the ability to use other disciplines to analyze legal issues relevant to the individual course topic, including economics, philosophy, and sociology, as appropriate.
Administrative and Regulatory Law Learning outcomes: Demonstrate a core understanding of administrative and regulatory law and the administrative process, including the role of statutory authorization and work of administrative agencies; Perform legal analysis in the context of administrative and regulatory law; Communicate effectively on topics related to administrative and regulatory law; Demonstrate an understanding of the role administrative and regulatory law play in our legal system and in society as a whole.