NUSLDrugLaw

 

DRUG LAW AND POLICY -- LAW 7606

Fall 2019

Hyperlinked syllabus available online at: http://bit.ly/NUSLDrugLaw

Course Information

Days           Monday, Wednesday

Time            3:20 – 4:50 PM

Location      42 Dockser Hall

        

Faculty

Michael S. Sinha, MD, JD, MPH

Adjunct Faculty, Northeastern University School of Law

Visiting Scholar, NUSL Center for Health Policy and Law

E-mail: m.sinha@northeastern.edu

Office Hours: By appointment, 14 Knowles, Monday/Wednesday afternoons

 

Teaching Assistant

            Abigail Fletes, 3L (fletes.a@husky.neu.edu)    

 

Course Description

The field of Drug Law spans the discovery, manufacture, distribution, and control of agents and devices that alter the human condition. This course provides an introduction to the regulatory regime created by the Federal Food, Drug and Cosmetics Act and the Food and Drug Administration and maps out connections to additional laws and institutions. In addition to traditional content on pharmaceutical regulation, we will examine topics such as human subjects concerns in clinical trials, the opioid crisis, tobacco control, the drug policy reform movement, and debates between human rights and intellectual property proponents in medication access. The course is intended for students contemplating legal practice involving pharmaceuticals, those thinking critically about the origins and directions of domestic and international drug control, as well as those interested in the interplay of law, policy, and public health. Students will be expected to participate actively and to conduct substantial research and writing.

 

Upon completion of the course, I will assess your achievement of the Learning Outcomes on page two of the evaluation, as follows:

  1. Gain an understanding of the US statutory and regulatory frameworks governing drugs, using Administrative Law and Public Health Law frameworks;
  2. Gain ability to critically assess and leverage strengths and weaknesses in various elements of the drug regulation regime;
  3. Develop skills and vocabulary to facilitate written, oral, and non-verbal communication;
  4. Apply experiential learning tools to prepare you for impactful and rewarding careers.

 

Texts:

Food and Drug Law: Cases and Materials, 4th Edition. Hutt, Merrill, Grossman (West Academic, 2013). ISBN: 9781609301750 (Print edition is required, available at the NUSL bookstore and on reserve); (hereinafter “Hutt”)

 

Online Resources:

HarvardX massive open online course (MOOC), “#HarvardXFDA: The FDA and Prescription Drugs—Current Controversies in Context,” available at: http://bit.ly/HarvardXFDA.

For the IP session, videos are available from the PennX MOOC, “Intellectual Property Law and Policy: Part 1,” available at: http://bit.ly/PennXIP.

For the Opioids sessions, videos are available from the HarvardX MOOC, “The Opioid Crisis in America,” http://bit.ly/OpioidX.

 

Students will register for edX and these three courses in order to peruse content and watch videos. Audit only: do not pay to upgrade to a certificate. The course introduction lecture will include a primer on the edX platform and how to access video content. Completion of edX course content not assigned in the syllabus is optional.

 

Student Responsibilities

  1. Readings and Videos: Readings from Hutt and #HarvardXFDA videos are always required. Optional readings are noted within the syllabus. Assigned readings should be completed before class. Copies of Hutt are available for purchase in NUSL Bookstore and on reserve at the law library.
  2. Attendance and Engagement: This component of the evaluation is based on: A. class attendance and punctuality , B. contribution to in-class structured policy debates (more information here); and C. participation and demonstrated engagement with the subject matter as evidenced by participation during class, during office hours, and at least twice weekly on Twitter (at #NUSLDrugLaw [optional but encouraged]).
  3. Midterm Assignment: A structured “public comment” brief (4-5 pages) will be due before the start of class on Wednesday, October 2, 2019. An assignment document containing the pertinent guidelines is here. Sample public comments can be found here and here.
  4. Final Paper: The final paper on a pre-approved topic should be 18-24 pages in length and contain appropriately formatted BlueBook references. A final paper proposal outlining the topic significance, key questions, expected outcomes and preliminary sources will be due before class on Monday, September 16, 2019.

    An assignment document containing the pertinent guidelines is
    here. Sample paper proposals can be found here and hereThe final assignment will be due before 3PM on Friday, November 15, 2019.

    As an incentive to produce the highest-quality papers possible, I will work with interested students after the quarter ends to prepare their essays for submission to an appropriate law student essay contest (optional).

 

Evaluation

Course evaluation is based on three primary components, apportioned as follows:

Attendance and Engagement                   20%

Midterm Assignment                                 20%

Final Paper                                               60%

 

CLASS SCHEDULE AND ASSIGNMENTS

[subject to change]

 

Aug. 26

1. INTRODUCTORY LECTURE: COURSE THEMES AND EXPECTATIONS

Aug. 28

2. FDA HISTORY and INTELLECTUAL PROPERTY

Sep. 4:

3. OVERVIEW OF ADMINISTRATIVE LAW, DRUG AND MEDICAL DEVICE REGULATION

Sep. 9

4. INVESTIGATIONAL NEW DRUGS, CLINICAL TESTING AND EXPANDED ACCESS/RIGHT TO TRY

Sep. 11:

5. NEW DRUG APPROVAL PROCESS, EXPEDITED PATHWAYS, LABELING, POSTMARKET SURVEILLANCE

Debate 1: Prescription Drug User Fees

Sep. 12:

6. ORPHAN DRUGS, HATCH WAXMAN, AND GENERIC DRUGS

Sep. 16:

7. BIOLOGICS AND BIOSIMILARS

ASSIGNMENT DUE: FINAL PAPER PROPOSAL

 

Sep. 18:

8. PHARMACEUTICAL COSTS

Sep. 23:

9. MARKETING AND FIRST AMENDMENT ISSUES

Debate 2: Off-Label Promotion

Sep. 25:

10. INTRO TO THE OPIOID EPIDEMIC

Oct. 2:

11. MARIJUANA POLICY

  • Readings: TBD
  • Guest Lecture: Shaleen Title, JD; Commissioner, Massachusetts Cannabis Control Commission

ASSIGNMENT DUE: MIDTERM PUBLIC COMMENT BRIEF

Oct. 7:

12. OPIOID LITIGATION, PARALLELS TO TOBACCO

Oct. 16:

13. NALOXONE AND MEDICATIONS FOR OPIOID USE DISORDER

Debate 3: Over-the-Counter Naloxone

Oct. 18:

14. PUBLIC HEALTH & HARM REDUCTION

Oct. 21:

15. CSA and DEA; COLLATERAL IMPACT: CIVIL RIGHTS, HEALTH AND ECONOMY

  • Excerpts from Controlled Substances: Crime, Regulation, and Policy (p.3-18; 52-84; 113-128)
  • Michelle Alexander. The New Jim Crow. New York: The New Press: 30-55.
  • Guest Lecturer: Ayana Jordan MD, PhD; Assistant Professor of Psychiatry, Yale School of Medicine and Medical Director, Recognizing and Eliminating disparities in Addiction through Culturally-informed Healthcare (REACH) Program (via videoconference)

Oct. 23:

16. IMPLEMENTATION GAPS: THE POLICY TRANSFORMATION PROCESS

Oct 28:

17. SCIENCE-BASED REGULATION

Debate 4: Should the FDA be independent?

Oct. 30:

18. MISCELLANEOUS: PHARMACEUTICAL ANTITRUST

Nov. 1:

19. MISCELLANEOUS: TRADEMARKS, OTC DRUGS, AND DIETARY SUPPLEMENTS

Nov. 4:

20. MISCELLANEOUS: ANTIBIOTIC CONSERVATION AND INNOVATION

Nov. 6:

21.  STUDENT PROJECT PRESENTATIONS

Student final project presentations

Wrap-up

 

The final paper is due before 3PM on Friday, November 15, 2019.