CSU East Bay: HSC 335

HSC 335 - Pharmaceutical, Biotechnology and Medical Device Policy

Spring 2021

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

Course Information
Day: Thursdays
Time: 2:45 – 4:00 PM Pacific Time
ONLINE ONLY: Webinar via Zoom, link in Slack channel

Faculty
Michael S. Sinha, MD, JD, MPH
Research Fellow, Harvard Medical School
Lecturer, Cal State University East Bay
E-mail: michael.sinha@csueastbay.edu (preferred method of communication is Slack DM)
Office Hours: By appointment

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

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

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.


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 prior to the start of class. The PDF copy is for your records only; I receive your answers as soon as you hit submit and do not need your PDF sent to me. 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 completed 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 discussion forum on Slack (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 by  The op-ed is due by March 26th. 
     
  5. Presentation: You will give a short presentation based on your op-ed. More information to come.
     
  6. Final Exam: This will be a take-home exam consisting of a two-page policy memo. On May 6th, I will give you several case scenarios and a template. You will choose one of the scenarios. The policy memo will be due in one week (May 13th) at MIDNIGHT PACIFIC TIME.
     
Course evaluation is based on three primary components, apportioned as follows:
  • Attendance, Participation, and Online Engagement 15%
  • Question Sets 25%
  • Midterm Assignment 25%
  • Presentation 10%
  • 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 may have increased work or 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 assignments, 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. 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 Etiquette:

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.
  • 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 part 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 should be muted during class. You may unmute yourself in order to speak or ask questions. Use the raise hand feature when possible.
  • 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.
  • We will try to take a short break 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 EXCEPT during presentations. Save discussions for the Slack #discussion channel or ask questions during class or during the break.
     

CLASS SCHEDULE [ALWAYS subject to change]

January 21

 

 

 

 

 

INTRODUCTORY LECTURE: COURSE THEMES AND EXPECTATIONS

Introduction to course, syllabus, and Slack
Introduction to the pharmaceutical and medical device industries

Begin reading the following articles:

January 28

 

 

 

 

FDA HISTORY AND LEGAL FRAMEWORK

Audio/Video
Week 1 YouTube Videos HERE.
Week 1 Questions HERE.


Continue reading the articles from Week 1 (above).

February 4

 

 

 

 

 

OVERVIEW OF ADMINISTRATIVE PROCESS, DRUG AND MEDICAL DEVICE REGULATION

Audio/Video
Week 2 YouTube Videos HERE.
Week 2 Questions HERE.

Readings
A COVID-19 Conversation with Dr. Anthony Fauci (podcast)
Coronavirus: Fact vs. Fiction with Biden's New Covid Team (podcast)
Racial and Ethnic Disparities Related to COVID-19 (article)
Mandating COVID-19 Vaccines (article)

February 11

 

 

 

INVESTIGATIONAL NEW DRUGS, CLINICAL TESTING

Audio/Video
Week 3 YouTube Videos HERE.
Week 3 Questions HERE.

Readings
How FDA Approves Drugs and Regulates Their Safety and Effectiveness (skim this one)
What is an EUA? Food and Drug Administration
The resurgence of convalescent plasma therapy, Lancet Haematology
Testing an Old Therapy Against a New Disease: Convalescent Plasma for COVID-19, JAMA
COVID-19 Vaccination Data by Race/Ethnicity, Kaiser Health News

February 18

 

 

 

 

 

 

 

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

Audio/Video
Week 4 YouTube Videos HERE.
Week 4 Questions HERE.

Readings

OP-ED TOPIC TO BE APPROVED BY DR. SINHA BY THE BEGINNING OF CLASS.

February 25

 

 

 

 

 

 

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, JAMA
I-MAK: Overpatented, Overpriced
TED Talk: Why Are Drug Prices So High?

March 4

 

 

 

 

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, JAMA Internal Medicine

Dr. Rochelle Walensky, JAMA Podcast, February 17, 2021
Dr. Paul Offitt, JAMA Podcast, February 11, 2021

March 11

 

 

 

 

PHARMACEUTICAL PROMOTION TO PHYSICIANS

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

Readings
Medical Marketing in the United States, JAMA
Pharmaceutical Advertising in Medical Journals, CHEST

March 18

 

 

 

 

DIRECT-TO-CONSUMER ADVERTISING AND OFF-LABEL PROMOTION

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

Readings
Drug Companies' Patient-Assistance Programs -- Helping Patients or Profits? NEJM
Prescription-Drug Coupons -- No Such Thing as a Free Lunch NEJM

March 25

 

 

 

 

 

POST-APPROVAL MONITORING AND EVALUATION OF PRESCRIPTION DRUGS, PART 1

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

Readings
Opioids Videos HERE. (NO questions associated with these videos)

OP-ED ASSIGNMENT TO BE SUBMITTED VIA SLACK BY MIDNIGHT PACIFIC TIME ON MARCH 26TH

April 1 SPRING BREAK: NO CLASS

April 8

 

 

 

 

POST-APPROVAL MONITORING AND EVALUATION OF PRESCRIPTION DRUGS, PART 2

Audio/Video
Week 10 YouTube Videos HERE.
Week 10 Questions HERE.

Readings
None

April 15

 

 

 

 

SPECIAL CATEGORIES: BIOLOGICS AND BIOSIMILARS

Audio/Video
Week 11 YouTube Videos HERE.
Week 11 Questions HERE.

Readings
Time to Throw In the Towel on Biosimilars - WSJ
Give Up On Biosimilars: Regulate Prices Instead - STAT News

April 22

 

 

 

 

 

 

 

 

 

 

 

 

SPECIAL CATEGORIES: NUTRITIONAL SUPPLEMENTS, ORPHAN DRUGS, AND DRUGS FOR CHILDREN

Audio/Video
Week 12 YouTube Videos HERE.
Week 12 Questions HERE.

Readings
NEJM Podcast: Vaccine Successes and Vaccine Adverse Events

Class Presentations Week 1
Ydalis Martinez
San Ong
Sabrina Chin
Riyad Murshed
Oriana Morris
Mikhail Barrett
Mark Jennison
Kristina Dacquel
Kiara Clark
Karla Munoz-Oseguera
Jocelyn Rivera
Giana Medeiros
Eshandeep Dhami
Christina Bailen
Brie Longeway

April 29

 

 

 

 

 

 

 

 

 

 

 

 

SPECIAL CATEGORIES: CANCER AND NEGLECTED TROPICAL DISEASES

Audio/Video
Week 13 YouTube Videos HERE.
Week 13 Questions HERE.

Readings
No additional readings

Class Presentations Week 2
Zoya Khan
Serena Vu
Samantha Calderon
Rondelle Cornelson
Richa Parshadh
Mary Antoniette Gular
Nicholas Conn
Lesley Sanchez
Kimberly Hoang
Katalina Luna
Juliet Jiminez Segun
Huy Dao
Fatuma Hussain
Devon Neak
Camila Gonzalez
Agnes Cerda

May 6

 

 

 

 

FINAL CLASS SESSION

No pre-class assignment, please use the additional time to fill out your course evaluation!

In-Class Discussion Groups:
Group 1: Fatuma Hussain, Devon Neak, Camila Gonzalez, Agnes Cerda
Group 2: Zoya Khan, Serena Vu, Samantha Calderon, Rondelle Cornelson
Group 3: Richa Parshadh, Mary Antoniette Gular, Nicholas Conn, Lesley Sanchez
Group 4: Kimberly Hoang, Katalina Luna, Juliet Jiminez Segun, Huy Dao
Group 5: Ydalis Martinez, San Ong, Sabrina Chin, Riyad Murshed
Group 6: Oriana Morris, Mikhail Barrett, Mark Jennison, Kristina Dacquel
Group 7: Kiara Clark, Karla Munoz-Oseguera, Jocelyn Rivera, Giana Medeiros
Group 8: Eshandeep Dhami, Christina Bailen, Brie Longeway

Take-Home Exam (Policy Memo):
Last year's prompt HERE.
Two excellent student exams from last year HERE and HERE.

THIS YEAR'S PROMPT is HERE.
WORD TEMPLATE is HERE.

Please check the #general channel on Slack for more information.

May 13

FINAL EXAM DUE VIA SLACK BY MIDNIGHT PACIFIC TIME (DM via Slack)