Pharma Regulation and Enforcement (Davar)
R 6:40PM - 8:40PM
Tanenbaum Hall 320
This course will provide students with an overview of the key regulatory, enforcement, and business considerations affecting the biopharmaceutical industry. By the nature of the material, some seminars will be more lecture driven, while others will be more student response driven. However, students are encouraged and expected to participate -- this helps drive the discussion, tailor the subject matter to the interests of the class, and make the experience of taking an evening seminar with a practitioner in the field that much more engaging. The course focuses around a few consistent themes each year and then varies based on cutting-edge issues, such as new regulations, new enforcement theories, policy shifts, or the ability to secure prominent guest speakers with particular perspective. As a result, the syllabus may change. The basic order of the course -- which outlines the theme/topic of each seminar discussion -- is as follows: (1) basics on regulatory agencies - FDA, HHS-OIG, CMS, (2) intended uses and "what is a drug", (3) the FDA drug approval process, (4) clinical research regulation, (5) drug manufacturing and quality, (6) relationships with healthcare providers and an introduction to the fraud and abuse laws, (7) deeper dive on the Anti-Kickback Statute, False Claims Act, and related safe harbors, (8) drug pricing and reimbursment, (9) compliance program design, and (10) anatomy of a regulatory crisis or internal investigation. Apart from these set themes, we will add content based on class preference and guest speaker availability. We usually have guest lecturers for 30-40% of our classes.
Please read: -Approved absences are fine - you should let me know 72 hours in advance of missing a class, if you can. Obviously, sickness or emergencies will allow for same-day notice. You will be asked to complete a reaction paper due 5pm on the Tuesday after the class day you missed, to get credit for the missed class. -Each class builds on the previous one, so students may not drop/add after the second day of class (meaning, if you want to make a change, do it before the second class meets) -Your professor is also a practitioner with a very active practice - there may be a need to reschedule classes or change class format due to unforseen circumstances like travel. You will be given as much advanced notice as possible, and workarounds like Zoom/Teams and lecture recordings will be used whenever possible. -There is no book to buy for this class, but you will be expected to be able to access readings through the web, Lexis/Westlaw, and PDF format. If you are not a full-time law student, please work with the Library to determine how best to get access to these resources if you need them. -Attendance is crtical to this course -- you will find that that in a class of 15 or less, the absence of discussion or debate makes things boring (for the students and the professor). Attendance and *participation* (speaking, emailing, showing interest in the material and what your classmates are saying) count for 60% of your grade. -The other 40% will be your final exam paper. -I will supervise papers for your "senior writing"/"comment" credit. This requires you to submit your final paper for grading just like everyone else, and then make edits/corrections and meet with me at least once to finalize your "comment" on an approved timeline. Please let me know in advance if you are a 3L and using this course for your comment. -Unfortunately, I cannot serve as your supervisor for a law review comment or other formal long form writing during the course year. I am open with talking with you about those opportunities outside of the Spring Semester schedule.
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.