CSU East Bay: HSC 335

HSC 335 - Pharmaceutical, Biotechnology and Medical Device Policy

Fall 2020

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

Course Information

Day                 Thursdays

Time                2:45 – 4:00 PM PST

Location          Webinar via Zoom: link in Slack channel

Faculty

Michael S. Sinha, MD, JD, MPH

Research Fellow, Harvard Medical School

Adjunct Faculty, Cal State University East Bay

E-mail: michael.sinha@csueastbay.edu (preferred method of communication is Slack DM)

Office Hours: By appointment

 

LEARNING OUTCOMES

Upon successful completion of the course, students will be able to:

    1. Understand the role and structure of the US pharmaceutical, medical device and biotech industries in the global marketplace.
    2. Recognize the role of manufacturing, research and development, technology, pricing and promotion in transforming the pharmaceutical, medical device and biotech industry.
    3. Discuss the role of government regulation in the pharmaceutical, medical device and biotech industry.
    4. Discuss the impact of mergers and acquisitions, joint ventures and alliances in the pharmaceutical, medical device and biotech industry.
    5. Discuss various ethical issues relevant to the pharmaceutical, medical device and biotech industry.

 

Texts: No required texts, all required readings will be provided in PDF format

Online Resources: Videos will be available on YouTube playlists (released each week)

 

STUDENT RESPONSIBILITIES

  1. Readings and Videos: Readings and videos are always required. Optional readings are noted within the syllabus. Assigned readings and videos should be completed before class.
  2. Question Sets: Each week’s assignments will have an associated question set. Answers must be submitted to me via direct message on Slack prior to the start of class. Each quiz will be worth 3 points, with 1 point deducted for late assignments and 1 point deducted for scores less than 70%. No points will be awarded if the quiz is not submitted by Friday night at 9:00 pm PST.
  3. Attendance and Engagement: This component of the evaluation is based on: A. class attendance and punctuality (5%), B. contribution to in-class discussion and policy debates (10%); and C. posting at least twice weekly on Twitter (at #PharmaPolicy [optional but encouraged]) (5% extra credit).
  4. Midterm Assignment: This will consist of a 600 to 800 word op-ed on a topic of your choosing. The topic must relate to the course or course materials. The topic must be pre-approved by Dr. Sinha, and the op-ed is due by October 1. Early FULL drafts can be submitted for feedback by September 25th.
  5. Presentation: You will give a short presentation based on your op-ed. More details to come.
  6. Final Exam: This will be a take-home exam consisting of a 1000 word policy memo. On December 3rd, I will give you three case scenarios. You will choose one. The policy memo will be due in one week (December 10th). More information to come.

 

Evaluation

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

Attendance and Engagement                                15%

Question Sets                                                        20%

Midterm Assignment                                              20%

Presentation                                                           20%

Final Exam                                                             25%

 

Learning During a Pandemic

Life absolutely sucks right now. None of us is really okay. We’re all just pretending. You most likely know people who have lost their jobs, have tested positive for COVID-19, have been hospitalized, or perhaps have even died. You all have increased (or possibly decreased) work responsibilities and increased family care responsibilities—you might be caring for extra people (young and/or old!) right now, and you are likely facing uncertain career prospects.

I’m fully committed to making sure that you learn everything you were hoping to learn from this class! I will make whatever accommodations I can to help you finish your exercises, do well on your projects, and learn and understand the class material. Under ordinary conditions, I am flexible and lenient with grading and course expectations when students face difficult challenges. Under pandemic conditions, that flexibility and leniency is intensified.

If you tell me you’re having trouble, I will not judge you or think less of you. I hope you’ll extend me the same grace. You never owe me personal information about your health (mental or physical). You are always welcome to talk to me about things that you’re going through, though. If I can’t help you, I can find somebody who can. If you need extra help, or if you need more time with something, or if you feel like you’re behind or not understanding everything, do not suffer in silence! Talk to me! I will work with you. I promise.

I want you to learn lots of things from this class, but I primarily want you to stay healthy, balanced, and grounded during this crisis.

 

Zoom Etiquitte:

With new technology come new guidelines. The following apply to class sessions on Zoom:

  • Attendance is required for all sessions. The sessions will not be recorded. Slides will be posted after class.
  • Unless it is an emergency, a request for an excused absence must come 48 hours before class starts. If you miss the presentation class session, you will not receive credit for that section of the grade.
  • If you are having technical issues, please use the Zoom application on your smartphone or call into the class (number in Slack channel).
  • All participants will be muted during class. You may unmute yourself in order to speak or ask questions.
  • You will not be required to have your video on for the entirety of the class. However, I will assume you are paying attention even if your video is off and may ask a question. Use the raise hand feature when possible.
  • We will take a 5 minute break around 3:25pm each day. Please mute yourself and turn your video off during this time.
  • Please make sure your name appears in Zoom as you’d like to be called.
  • The chat function will not be used during class. Save discussions for the Slack #discussion channel or ask questions during class or during the break.

 

CLASS SCHEDULE

[subject to change]

 

Aug. 20

INTRODUCTORY LECTURE: COURSE THEMES AND EXPECTATIONS

 

Introduction to course, syllabus, and Slack
Introduction to the pharmaceutical and medical device industries
No pre-class assignments

Aug. 27

FDA HISTORY AND LEGAL FRAMEWORK

 

Audio/Video
Week 1 YouTube Videos here.
Week 1 Questions (on Slack and here).
JAMA Podcast with Dr. Stephen Hahn here.

 

Readings
Food and Drug Administration, 80 Years of the Federal Food, Drug, and Cosmetic Act
Chapter 1, Food and Drug Law: Cases and Materials

Sep. 3

OVERVIEW OF ADMINISTRATIVE PROCESS, DRUG AND MEDICAL DEVICE REGULATION

 

Audio/Video
Week 2 YouTube Videos here.
Week 2 Questions (on Slack and here).
IDSA Podcast with Dr. Anthony Fauci here.

 

Readings
How FDA Approves Drugs and Regulates Their Safety and Effectiveness, Congressional Research Service
What is an EUA? Food and Drug Administration
The resurgence of convalescent plasma therapy, Lancet Haematol. 2020 May;7(5):e353.
Testing an Old Therapy Against a New Disease: Convalescent Plasma for COVID-19, JAMA. 2020 Apr 30.doi: 10.1001/jama.2020.7456.
The FDA must stand up for itself and for science not politics, The Washington Post.

Sep. 10

INVESTIGATIONAL NEW DRUGS, CLINICAL TESTING

 

Audio/Video
Week 3 YouTube Videos here.
Week 3 Questions (on Slack and here).

 

Readings
The Emergence of the Randomized, Controlled Trial, N Engl J Med 2016; 375:501-504.
Drug Evaluation during the COVID-19 Pandemic, N Engl J Med. 2020 Jun 11;382(24):2282-2284.
Finding Effective Treatments for COVID-19: Scientific Integrity and Public Confidence in a Time of Crisis, JAMA. 2020;10.1001/jama.2020.6434.
Efficacy of Remdesivir in COVID-19, JAMA. 2020 Aug 21.doi: 10.1001/jama.2020.16337.

Sep. 17

NEW DRUG APPROVAL PROCESS, EXPEDITED PATHWAYS, LABELING, AND POSTMARKETING SURVEILLANCE

 

Audio/Video
Week 4 YouTube Videos here.
Week 4 Questions here.
Podcast: https://edhub.ama-assn.org/jn-learning/audio-player/18526495

 

Readings
Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine doi:10.1001/jama.2020.18860
Fairly Prioritizing Groups for Access to COVID-19 Vaccines doi:10.1001/jama.2020.18513
The Climate Crisis and COVID-19: A Major Threat to the Pandemic Response N Engl J Med 2020; 383:e70

Sep. 24

PHARMACEUTICAL COSTS

 

Audio/Video
Week 5 YouTube Videos here.
Week 5 Questions here.

 

Readings
Kaiser Health News: Talk About Déjà Vu: Senators Set To Re-Enact Drug Price Hearing Of 60 Years Ago.
The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. 316 J. Am. Med. Ass’n. 858 (2016).
I-MAK: Overpatented, Overpriced
TED Talk: Why Are Drug Prices So High?

Oct. 1

MARKET EXCLUSIVITY, GENERIC DRUGS, AND GAMES

 

Audio/Video
Week 6 YouTube Videos here.
Week 6 Questions here.

 

Readings

Strategies That Delay Market Entry of Generic Drugs. 177 J. Am. Med. Ass’n. Internal Med. 1665 (2017).

Podcast: Open Source -- Warped Speed

Oct. 8

PHARMACEUTICAL PROMOTION TO PHYSICIANS

 

Audio/Video
Week 7 YouTube Videos here.
Week 7 Questions here.

 

Readings
Unsustainable Drug Prices: Executive Summaries of 5 New Reports (read this BEFORE watching the videos)

House Committee on Oversight and Reform: Unsustainable Drug Prices: Testimony from the CEOs (Part I) (only watch from 3:18:20 to end)

Oct. 15

DIRECT-TO-CONSUMER ADVERTISING AND OFF-LABEL PROMOTION

 

Audio/Video
Week 8 YouTube Videos here.
Week 8 Questions here.

 

Readings
House Committee on Oversight and Reform: Unsustainable Drug Prices: Testimony from the CEOs (Part II) (only watch from 3:06:51 to 3:19:56)

Drug Companies' Patient-Assistance Programs -- Helping Patients or Profits? N Engl J Med 2014; 371:97-99

Prescription-Drug Coupons -- No Such Thing as a Free Lunch N Engl J Med 2013; 369:1188-1189

Oct. 22

POST-APPROVAL MONITORING AND EVALUATION OF PRESCRIPTION DRUGS

 

Audio/Video
Week 9 YouTube Videos here.
Week 9 Questions here.

 

Readings
What Should I Know About Opioids?
Opioids Videos here. (NO questions associated with these videos)