Northeastern University College of Professional Studies ...the drug, biologic & medical device...

© 2018 Northeastern University: College of Professional Studies

Northeastern University College of Professional Studies

Course Syllabus

Food, Drug, and Medical Device Law: Topics and Cases (RGA6203) _________________________________________________________________________ _________________________________________________________________________ CRN: 20121 Course: RGA 6203: Food, Drug, and Medical Device Law: Topics and Cases Boston Main Campus (BOS) Winter 2018, 12-week term January 8, 2018 – April 6, 2018 Course Format: On Ground Traditional Time: Tuesday, 5:50 – 8:30

Note: For courses meeting on campus, room assignments will be available online by the start of term in MyNEU/Self Service Banner.

Instructor: Jacob G. Weintraub, Esq. [email protected] Preferred contact method: Email (Emails will returned with 24-48 hours) Phone Number: available upon request or in Blackboard at the start of term.

Required Text(s)/Software/Tools: There is no required textbook for this course. Weekly lecture material may be supplemented with additional reading. This course examines topics found in the Food, Drug & Cosmetic (FD&C) Act so it is advisable to print the relevant section in advance from publicly available databases.

Recommended Textbooks/Resources: Federal Food, Drug, and Cosmetic Act (FD&C Act): http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

Course Prerequisites: RGA6203: Prereq. RGA 6200 or RGA 6202. As a graduate level course, each student should possess a general familiarity with FDA laws and regulations. In addition, each student should have a basic understanding of how a company in an FDA‐regulated industry operates, including knowledge of day‐to‐day activities in areas of research, development, manufacturing and commercialization. Prior undergraduate coursework in biology, chemistry, engineering or general life science areas will provide a good foundation as science issues arise in the context of legal and regulatory requirements.

mailto:[email protected]


Course Description: Analyzes current food, drug, and medical device laws. Reviews legislation and landmark cases, as well as laws governing development, manufacture, and commercial distribution of drugs, biologics, and medical device products and how they relate to the biotechnology, pharmaceutical, and medical device industries. (http://www.cps.neu.edu/courses/detail/RGA6203)

Course Outcomes: RGA6203 is designed to familiarize students with the regulations that govern all facets of the drug, biologic & medical device industry including development, manufacturing and commercial distribution. The course is designed to give students the opportunity to:

• Obtain the skills needed to read, brief and interpret judicial opinions. • Interpret the FD&C Act – laws, regulations and guidance and apply it to

complex issues identified in the drug and medical device industry today.

Course Methodology Each week, you will be expected to: 1. Review the week's learning objectives 2. Complete all assigned readings 3. Complete all lecture materials for the week 4. Participate in the Discussion Board 5. Complete and submit all assignments and tests by the due dates 6. Proactively contact the instructor with any questions or concerns The Food, Drug & Medical Device Law: Topics & Cases course will be taught in “Socratic Method” in which reading assignments are completed, and questions will be raised in class, inviting students to respond and comment. Each student is expected to substantially contribute to the in class discussion and promote debate to explore all aspects of FDA law.

Primary reading assignments consist of prepared presentations, case law/judicial opinions, legal commentary and statutory law. Supplemental readings will either be posted for your reading, or you will be asked to search the web and retrieve them yourselves. Each week you will be expected to complete the lesson, read the appropriate material, and participate in the discussions.

Participation/Discussion Board Students are responsible for any communications sent to their official, NEU-husky e-mail account.


Active participation in regulatory affairs courses is defined by both the quantity and quality of contributions. You are expected to have completed the reading and lecture material, and any assignments prior to class and given the content considerable thought. Your contributions must be submitted by stated deadlines unless other arranged beforehand. High quality contributions advance the class discussions and do not simply summarize the material that was assigned. Quality contributions take into account not only the instructors questions but also your classmates’ contributions. When participating in class, students are expected to be polite, respectful of other students and the instructor, and to contribute to the course at a level fitting of a graduate-level program. The instructor reserves the right to penalize students for repeated violations of the participation policy within a course.

Attendance Policy: In both on-ground and online courses, you are expected to attend all classes and discussions for the entire length of term. In addition, you will also be expected to complete assignments and group projects outside of class.

Students will be penalized for all unexcused absences. The University does allow for certain types of excused absences. ((http://www.cps.neu.edu/student-resources/images/CPS-Stu-

Handbook2013-2014.pdf) However, you will be expected to notify your instructor at least 24 hours in advance for all absences from class. In addition, you may approach your instructor to make prior arrangements for missing a class for other reasons. Approval for absences is at the instructor's discretion. In the case of a missed course or excused absence, including during the add-drop period, students are expected to make arrangements with the instructor to make up all materials in a timely fashion. Attendance of all lectures is a requirement of the course. Any anticipated absence should be discussed with the Professor first, or shortly after such absence. In this regard, Students are responsible for the course material of any lecture that was missed, and are encouraged to discuss with their fellow Students the particulars of how the material was presented. Students may be required to prove their understanding of the course material that they missed, particularly after multiple absences; failure to prove adequate understanding of the material that was missed may result in significant reduction in the Student’s class participation grade. Due to the amount of material covered in this course, students who attempt to join the class after the deadline for adding/dropping courses will require special permission from the instructor, which shall be granted in very limited circumstances.

http://www.cps.neu.edu/student-resources/images/CPS-Stu-Handbook2013-2014.pdf

http://www.cps.neu.edu/student-resources/images/CPS-Stu-Handbook2013-2014.pdf


Tardiness Policy for On-ground Courses Students will be given a single warning for tardiness. Students may be marked down for every late appearance to class after the initial warning. Students should make all possible attempts notify the instructor at least 48 hours prior to missing a course meeting. In the case of a missed course, including during the add-drop period, students are expected to make up all materials. In the case of unexcused absences, a student may be marked down for every missed course after the first week.

TurnItIn® As per departmental policy, all written work for both on-ground and online courses must be submitted in electronic format (.doc, .docx. or .pdf) to the Blackboard site associated with the course by the specified deadline. Your written work will be reviewed by TurnitIn® in order to check for originality and correct citation practices. Additionally, your instructor or TA may request a printed paper copy for his or her records.

Online assessments: In the case of online assessments, all of the general grading particulars apply. In addition, students are expected to be familiar with taking exams on Blackboard. They should consult with Blackboard Technical Help if additional support is required. A guidance document will be provided for students to read prior to launching each assessment. The document explains the reset policy and all expectations regarding taking quizzes and exams. Students are expected to read the document and ask any questions regarding the policies prior to launching the quiz / exam on Blackboard. In the case of technical error during an examination, NUOnline ([email protected]) and the instructor should be notified immediately and the e-mail and help-ticket reference case retained. Grading of work affected by technical error is still at the discretion of the instructor.

Technical Issues: In the case of technical issues for online assignments, NUOnline ([email protected] or 24/7 Phone support at 1-855-836-3520) and the instructor should be notified immediately and the e-mail and help-ticket reference case retained. Please note, technical issues are not a sufficient excuse for missing deadlines, therefore students may or may not receive credit for late material at the discretion of the instructor.

Late Assignment policy: A student should make every effort to turn his or her work in on time. No late work will be accepted without prior agreement with the instructor. Academic honesty standards will be strictly enforced by the instructor and the department. A deduction of 20% percent/ one letter grade will be made for each day that an assignment is late. Work will no longer be accepted 3 days after the specified deadline, unless specific arrangements have been made with the instructor.

Grading/Evaluation Standards This course will adopt the standard Northeastern University – University College policies on class attendance.




Student participation during class will weigh heavily on the overall grade for the course (30%). The balance of the final grade will be based upon: 1) A writing assignment (~ 1,000 word memorandum format; 20% of grade) 2) A short midterm exam (Exam 1) “take home” (20%)

3) A final examination (20%). An in-class exam consisting of true / false, multiple choice, short answer and short essay questions. 4) A series of in-class quizzes (10%). These quizzes are designed to ensure students are studying the material covered in prior lectures; the total of which shall be aggregated and averaged to determine their final Quiz grade.

Outstanding performance in this course will be evidenced by diligent attention to weekly reading assignment, meaningful participation (online or in class), demonstrated ability to understand and relate legal and regulatory concepts introduced during the course, and well researched and persuasively written final exam essay questions. A reduced grade is likely for assignments submitted late. In addition, students that do not reasonably adhere to the length limitations for writing assignments will likely receive a grade deduction. Written Assignments Content, organization, and mechanics all will be considered in grading final versions of written assignments. There is the expectation that students’ written work will be clear, comprehensible and competently produced. Students who submit work after the deadline (i.e., late) will be penalized at the Instructor’s discretion. Work is considered late if it is not handed in at the start of the class in which it is due. Students that do not adhere to the page limitations for assignments will receive deductions Written Assignment 1 In this course, students will learn to dissect a legal brief. Using the internet, law library or other resource, students will identify a legal case of personal interest and relevant to the course. Students will prepare a brief according to the Conclusion, Rule, Explanation, Application, and Conclusion (CREAC) system. Additional detail will be provided with the directions of the Assignment.


Grading Scale The grades will be broken down by the following scale:

95-100% A 4.0

90-94% A- 3.7

87-89% B+ 3.3

84-86% B 3.0

80-83% B- 2.7

77-79% C+ 2.3

74-76% C 2.0

70-73% C- 1.7

69% or below F 0.0

Please remember, each student’s performance in a given course will be evaluated independently of the quality or work completed for- or the grade he or she has earned in other courses.


Class Schedule /Topical Outline

Week Topics/Readings Weekly Outcomes/ Objectives

Assignments / Assessments

Part I: Legal Foundation for Regulatory Affairs

Week 1

1/9/18

Introductory comments Summary overview of FDA Regulatory Affairs from a legal perspective; Overview of the U.S. Legal system and State/Federal system of governance;

Structure and Function; branches of Government;

Delegation of Powers, Legislative process;

Relationship among Bills, Statutes, Executive Orders, Regulations, Guidance documents; Federal register

Overview of the Food, Drug and Cosmetic Act (FD&C Act) and related laws; Structure of Federal Agencies including the Food & Drug Administration; Reading: Posted Slides

Obtain general understanding of Legal System and Office of Regulatory Affairs from a legal perspective

Week 2

1/16/18

Introduction to Administrative Law (basis for FDA Regulatory Affairs)

Federal Administrative Procedures Act (FAPA)

Agency Rulemaking practices & procedures (per FAPA)

Judicial challenges to Agency exercise of Power Understanding Case Law – “How to 'brief' a judicial opinion” Issue, Rule, Analysis and Conclusion (IRAC) The “other” IRAC: Conclusion, Rule, Explanation, Application, and Conclusion (CREAC) Administrative Law: Summary of Seminal Case law

Obtain an understanding of statutory language and brief understanding of Administrative Law (ultimately to be seen in FDCA)


• Skidmore v. Swift & Co., 323 U.S. 134 (1944) • Chevron U.S.A. Inc. v. Natural Res. Def. Coun., Inc., 467 U.S. 837 (1984) • United States v. Mead Corp., 120 S. Ct. 2164, 2188 (2001)

Reading: Posted Slides

Week 3

1/23/18

Administrative Law: Detailed Review of Seminal Case law

• Principle of Stare Decisis

• “Skidmore acknowledgement of Executive Agency role” • “Chevron Deference” to Agency decisions • “Agency authority and influence waning? Pendulum swings both ways

End of Administrative Law review: Legal underpinnings of Regulatory Affairs Reading: Posted Slides

Obtain the skills needed to read, brief and interpret judicial opinions

Assignment 1 (distributed)

Part II: Statutory Foundation for Regulatory Affairs –

Federal Food, Drug & Cosmetic Act

Week 4

1/30/18

Overview of the Food, Drug & Cosmetic (FD&C) Act, Reading: Chapters I-X

Interpret the cited FD&C Act Chapters, and apply it to complex issues identified in the drug and medical device industry today

Assignment 1 Due;

Read section(s) of FD&C Act;

Exam 1 (Weeks 1‐3) distributed

Week 5

2/6/18

FD&C Act and progeny FDA regulations: Reading: § 501 (Adulteration), §502 (Misbranding)

Interpret the cited FD&C Act Sections, and apply it to complex issues

Exam 1 Due Read section(s)

of FD&C Act


identified in the drug and medical device industry today

Week 6

2/13/18

FD&C Act and progeny FDA regulations: Reading: § 503 (Exemptions…) through §505 (New Drugs) compare §§ 505(b)(1) vs 505(b)(2) vs 505(j)

Interpret the cited FD&C Act Sections, and apply it to complex issues identified in the drug and medical device industry today

Read section(s) of FD&C Act

Week 7

2/20/18

FD&C Act and progeny FDA regulations: Reading: § 503 (Exemptions…) through §505 (New Drugs) compare §§ 505(b)(1) vs 505(b)(2) vs 505(j)



Week 8

2/27/18

FD&C Act and progeny FDA regulations: Reading: § 510 (cont’d) through § 515 (Premarket Approval)



Week 9

3/6/18

FD&C Act and progeny FDA regulations: Reading: § 510 (cont’d) through § 515 (Premarket Approval)




Week 10

3/13/18

FD&C Act and progeny FDA regulations: Reading: § 516 , § 520 (Miscellaneous) through § 523 (Accredited Persons)



Assignment 2 distributed

Week 11

3/20/18

FD&C Act and progeny FDA regulations: selected remaining sections of the Act. End of FD&C Act review: Statutory underpinnings of FDA Regulatory Affairs


Assignment 2 due


Week 12 3/27/18

Final Exam – Part I Multiple Choice Exam Interpret the FD&C Act, and apply it to complex issues identified in the drug and medical device industry today


Exam 2 (Weeks 4‐12)

Complete your course evaluations in EvalKit

You can find term dates with your contract documents or on the Registrar website/Calendar page. http://www.northeastern.edu/registrar/calendars.html

Academic Integrity Policy

The University views academic dishonesty as one of the most serious offenses that a student can commit while in college and imposes appropriate punitive sanctions on violators. Here are some examples of academic dishonesty. While this is not an all-inclusive list, we hope this will help you to understand some of the things instructors look for. The following is excerpted from the University’s policy on academic integrity; the complete policy is available in the Student Handbook. The Student Handbook is available on the CPS Student Resources page > Policies and Forms. Cheating – intentionally using or attempting to use unauthorized materials, information or study aids in an academic exercise

Unauthorized use of notes, text, the Internet, or other aids during an examination.

Copying from another student’s academic work.

Unauthorized communication during an examination.

http://www.northeastern.edu/registrar/calendars.html

http://www.cps.neu.edu/student-resources/


Handing in the same paper for more than one course without explicit permission from the instructor(s).

Fabrication – intentional and unauthorized falsification, misrepresentation, or invention of any data, or citation in an academic exercise Plagiarism – intentionally representing the words, ideas, or data of another as one’s own in any academic exercise without providing proper citation

Word-for-word quotations from a source, including another student’s work.

Paraphrasing (using the ideas of others in your own words).

Unusual or controversial facts not widely recognized.

Audio, video, digital, or live exchanges of ideas, dialogues, or information. Additionally, the Regulatory Affairs Department and its instructors would like to remind all students that proper citation requires both quotation marks and thoroughly documented references:

1. When writing, if using someone else’s exact words, these words, phrases, sentences, paragraphs, etc. must be enclosed in quotation marks and their source be properly cited in parenthetical documentation, footnote, or endnote format as specified by the instructor. Any use of the words of another person without quotation marks will be considered academically dishonest.

2. Any use of the idea of another person, even if paraphrased by the student author, must be marked by proper citation, whether parenthetical documentation, footnote, or endnote format as specified by the instructor. The use of the idea of another author without proper citation will be considered academically dishonest.

Unauthorized collaboration – instances when students submit individual academic works that are substantially similar to one another; while several students may have the same source material, the analysis, interpretation, and reporting of the data must be each individual’s independent work. Participation in academically dishonest activities – any action taken by a student with the intent of gaining an unfair advantage Facilitating academic dishonesty – intentionally or knowingly helping or attempting to violate any provision of this policy For more information on Academic Integrity, including examples, please refer to the Student Handbook, pages 9-11.


Northeastern University Online Policies and Procedures For comprehensive information please see the download the Student Handbook also available on the Student Resources page of the Northeastern University College of Professional Studies website.

End-of-Course Evaluation Surveys Your feedback regarding your educational experience in this class is very important to the College of Professional Studies. Your comments will make a difference in the future planning and presentation of our curriculum. At the end of this course, please take the time to complete the evaluation survey at https://neu.evaluationkit.com. Your survey responses are completely anonymous and confidential. For courses 6 weeks in length or shorter, surveys will be open one week prior to the end of the courses; for courses greater than 6 weeks in length, surveys will be open for two weeks. An email will be sent to your HuskyMail account notifying you when surveys are available.

Northeastern University Online Copyright Statement Northeastern University Online is a registered trademark of Northeastern University. All other brand and product names are trademarks or registered trademarks of their respective companies. This course material is copyrighted and Northeastern University Online reserves all rights. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the express prior written permission of Northeastern University Online. Copyright 2014 - 2018 © by Northeastern University Online All Rights Reserved

Instructor Biographical Sketch Graduating cum laude from Suffolk University Law School, Mr. Weintraub has been an instructor of this course for 7 years, and has about 17 years of experience in drafting and prosecuting both U.S. and foreign patent applications, preparing opinions, and counseling both small and large clients on a range of strategic intellectual property issues. Mr. Weintraub is Senior Counsel at the law firm of JWIP & Patent Services, LLC, and prior to that was an integral member of the Global Intellectual Property Department of a major international pharmaceutical company. Prior to joining this global in-house team, he practiced in the Boston office of an international general practice law firm as a senior associate in the Intellectual Property Group, specializing in chemistry and biotechnology. The years preceding this, Mr. Weintraub practiced patent law at a leading Boston-based patent boutique law firm.

http://www.cps.neu.edu/images/CPS-Stu-Handbook2012-2013.pdf

http://www.cps.neu.edu/student-resources/

http://www.cps.neu.edu/

https://neu.evaluationkit.com/


Recommended Writing Resources:

Northeastern University Tutoring Services: http://www.cps.neu.edu/student-resources/tutoring-services.php Services include Tutoring Center, Writing Center, and Smarthinking – available to online and on-ground students Northeastern University Academic Integrity page: http://www.cps.neu.edu/student-resources/academic-integrity.php Purdue University Online Writing Lab Purdue University (2014). Purdue University Online Writing Lab (OWL). Available: https://owl.english.purdue.edu/owl/

http://www.cps.neu.edu/student-resources/tutoring-services.php

http://www.cps.neu.edu/student-resources/academic-integrity.php

https://owl.english.purdue.edu/owl/

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